<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03781271</url>
  </required_header>
  <id_info>
    <org_study_id>143-2018</org_study_id>
    <nct_id>NCT03781271</nct_id>
  </id_info>
  <brief_title>ElectroMagnetic-guided Interstitial Catheter Navigation for Gynecological brachyTherapy</brief_title>
  <acronym>E-MINT</acronym>
  <official_title>ElectroMagnetic-guided Interstitial Catheter Navigation for Gynecological brachyTherapy: A Phase I Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase I study evaluating the feasibility of using electromagnetic navigation (EMN) for the&#xD;
      catheter implantation procedure required of cervical brachytherapy. The addition of EMN to&#xD;
      the current HDR brachytherapy workflow has the potential to dramatically improve implant&#xD;
      quality and efficiency for the gynecological interstitial brachytherapy program. Implant&#xD;
      quality has been reported to be an important predictive factor for local control and late&#xD;
      toxicity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cervical cancer poses a significant local and global health problem. In 2017 over 1,500&#xD;
      Canadian women were predicted to develop cervical cancer, and another 400 were approximated&#xD;
      to die from the disease. Cervical cancer rates have steadily decreased in developed nations&#xD;
      largely due to regular gynaecological screening and public human papillomavirus vaccination&#xD;
      programs; however, the disease accounts for up to 12% of all female cancer diagnoses in&#xD;
      developing nations, and poses a disproportionate burden on aboriginal women across Canada.&#xD;
      Much work needs to be done to address disparities in care and treatment for cervical cancer,&#xD;
      both in Canada and worldwide.&#xD;
&#xD;
      FIGO stage IA - IB1 is considered localized disease and treated primarily with surgery. In&#xD;
      contrast to early stage disease, tumours that extend greater than 4 cm and beyond the cervix&#xD;
      are considered locally advanced. The standard of care for locally advanced cervical cancer&#xD;
      defined as FIGO stages IB2 - IVA is external beam radiation therapy with concurrent&#xD;
      chemotherapy followed by brachytherapy.&#xD;
&#xD;
      Brachytherapy is a crucial component of therapeutic management that has been shown to be&#xD;
      associated with improved local control. High dose rate brachytherapy involves the treatment&#xD;
      of local bulky disease using a remotely loaded Iridium-192 source. Brachytherapy delivery&#xD;
      exploits rapid dose fall off, allowing for the central pelvis to receive a very high dose&#xD;
      while sparing the bladder, rectum, sigmoid and small bowel. This dose escalation is beyond&#xD;
      what is conventionally achievable using external radiation therapy methods. More&#xD;
      specifically, image guided adaptive brachytherapy employing intracavitary applicators allows&#xD;
      for dose optimization and improves target dose coverage for limited size tumours.&#xD;
&#xD;
      Intracavitary applicators have been shown to be adequate from covering symmetric small&#xD;
      tumours less than 30 cc. However, for large or complex asymmetric tumours with/without&#xD;
      vaginal involvement they are not sufficient to cover the target while respecting normal&#xD;
      tissue tolerances. To compensate for these limitations, improvements in local control have&#xD;
      been achieved using a combined interstitial and intracavitary technique for larger tumours.&#xD;
      Combined intracavitary - interstitial applicators have been designed to target tumours that&#xD;
      are not adequately covered by intracavitary applicators alone. The addition of the&#xD;
      interstitial technique involves the insertion of catheters into the tumour enabling higher&#xD;
      dose conformity and normal tissue sparing. This combined technique has been shown in large&#xD;
      tumours with extensive parametrial involvement as well as in cases with unfavourable&#xD;
      topography to be effective. Employing this combined technique, perineal-based interstitial&#xD;
      image guided adaptive brachytherapy makes it possible to deliver higher doses to the high&#xD;
      risk clinical target volume without increasing dose to the bladder, rectum or sigmoid.&#xD;
&#xD;
      The combined interstitial and intracavitary brachytherapy workflow for locally advanced&#xD;
      cervical cancer at the Odette Cancer Centre typically consists of four treatment fractions.&#xD;
      The workflow begins with a pre-brachytherapy assessment MRI that is taken before&#xD;
      brachytherapy treatment to assist in preplanning of catheter depth and location. At the time&#xD;
      of this MRI the patient will have a vaginal cylinder in place. 1-2 weeks after the MRI, the&#xD;
      implant and treatment is performed. Prior to the implantation procedure, the patient is given&#xD;
      light sedation and a spinal anesthetic, subsequently a vaginal cylinder (Best Medical&#xD;
      Systems, Inc, Springfield VA) is inserted into the patient. A perineal template that contains&#xD;
      a central opening is fit on the vaginal cylinder. The template is then advanced until it is&#xD;
      appositional on the perineum of the patient. Plastic catheters (6F 24 cm) containing metal&#xD;
      stylets are inserted through the template and along the grooves of the vaginal cylinder&#xD;
      thereby penetrating the perineum and the vagina, respectively. The number, position and depth&#xD;
      of the catheters that are used are based on the pre-brachytherapy assessment MRI. After the&#xD;
      implantation procedure the template is sutured to the patient and the patient is transferred&#xD;
      to an MRI suite where an image of her anatomy is acquired with the catheters and applicators&#xD;
      in place. The patient is then sent for a CT scan that is to be used for treatment planning.&#xD;
&#xD;
      Treatment planning involves the registration of the CT and MR datasets. The MR images are&#xD;
      used to identify the soft tissue organs at risk and the targets. The CT is used to identify&#xD;
      the catheters implanted in the patient. Using the knowledge of where the applicator/catheters&#xD;
      are with respect to the targets and organs at risk, a dose distribution is designed to target&#xD;
      the cancer while sparing normal tissue. On the same day as the implantation, one treatment&#xD;
      fraction is delivered and the patient is admitted overnight. The next day the patient may as&#xD;
      a standard of care, depending on the clinical indication undergo one or two additional&#xD;
      fractions, separated by at least 6 hours. A week later the same process for the first two&#xD;
      fractions will be repeated for the remaining two fractions.&#xD;
&#xD;
      During the insertion of catheters, it has been recognized that they can converge or diverge&#xD;
      as they pierce stiff tissues along the implantation path. Without proper image guidance, a&#xD;
      template guided interstitial implant could result in an increase in risk of normal tissue&#xD;
      complications. Real-time image guidance for catheter insertion is institution dependent, at&#xD;
      the Odette Cancer Centre trans-abdominal ultrasound is used for placement of the tandem and&#xD;
      more recently the trans-rectal ultrasound has been investigated for catheter placement. Other&#xD;
      forms of real-time catheter guidance used at different centres include fluoroscopy, computed&#xD;
      tomography (CT), and magnetic resonance imaging (MRI).&#xD;
&#xD;
      The quality of interstitial brachytherapy implants has been reported to be an important&#xD;
      predictive factor for local control and late toxicity. The quality of the implant is&#xD;
      dependent on the geometry of the catheters, and real time image guidance for interstitial&#xD;
      cervical brachytherapy is markedly lacking.&#xD;
&#xD;
      At the Odette Cancer Centre, a four-patient study was conducted to characterize the amount of&#xD;
      catheter deflection and angulation during gynaecological high-dose-rate interstitial&#xD;
      brachytherapy. Results from this study demonstrated that the mean value of the maximum&#xD;
      catheter deflection at the level of the GTV was 9.1 mm +/- 3.2 mm (range 3.0 - 18.4 mm) and&#xD;
      can approach as much as 2 cm at the level of the GTV. Although the catheter deflection&#xD;
      observed in this study did not result in any significant dosimetric impact the sample size&#xD;
      was small and the authors of the study suggested that further investigation into real-time&#xD;
      catheter guidance may be necessary into alleviating this deviation to prevent suboptimal plan&#xD;
      quality.&#xD;
&#xD;
      Electromagnetic tracking can minimize the uncertainties related to implant quality. The&#xD;
      operation of an electromagnetic tracking device depends on a field generator producing a&#xD;
      magnetic field that extends across the anatomy of interest. The tracked sensor in this system&#xD;
      induces a distance-dependent voltage that is used to determine the spatial position of the&#xD;
      sensor within the volume of interest. This technology is extensively used in clinical&#xD;
      practice, examples include, surgical interventions, guidance of biopsies, and motion&#xD;
      monitoring.&#xD;
&#xD;
      Electromagnetic navigation can be incorporated into the cervical interstitial brachytherapy&#xD;
      workflow as a form of real-time catheter guidance. By incorporating this guidance into the&#xD;
      current workflow it is possible that a higher degree of accuracy in catheter placement will&#xD;
      be achieved when used in conjunction with image-guided brachytherapy. This study seeks to&#xD;
      evaluate the efficacy of electromagnetic navigation on the perineal-based interstitial cervix&#xD;
      image-guided brachytherapy workflow as part of a phase I clinical trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">October 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>2 arms of patients will undergo standard routine brachytherapy treatment. A part of the treatment involves the placement of catheters. For both arms of the study the placement of these catheters will be assisted by an electromagnetic navigation system. The difference between the arms will be that the navigation system will be used at different times in the course of their brachytherapy treatment to eliminate bias. One group will undergo electromagnetic navigation assisted catheter placement during their first fraction of treatment while the second arm will undergo electromagnetic navigation assisted catheter placement during their third fraction of treatment.</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment Plan Target Volume and Organs at Risk Dosimetry</measure>
    <time_frame>14 days</time_frame>
    <description>The treatment plans generated during the course of treatment for participants will be evaluated. The evaluation of the treatment plans will use the dose received by specific target structures and the dose received by structures that are defined as organs at risk. The specific metric that will be used represents how much dose is received by a certain percentage of a volume. For example, the D98 GTV refers to how much dose is received by 98 percent of the gross tumour volume. The dose is a value that is measured in the unit, Gray. In addition to the dose constraint for the D98 GTV the other dose constraints that will be used for evaluation purposes are, D90 HR-CTV, D98 HR-CTV, D98 IR-CTV and OAR constraints. A significance level of 5% will be used to identify differences between the dose constraints for treatment plans that are generated when EMN is used and when EMN is not used.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>Fraction 1-Addition of EMN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the fraction 1 insertion, the custom MRI-compatible vaginal cylinder will be placed in the patient, and will contain the 6 degree-of-freedom (DOF) sensor. The electromagnetic navigation system and computer will have been setup in the operating room (OR) prior to the procedure and will be used to actively insert up to 25 catheters into the target. The catheters will be inserted using a custom metallic stylet that has a custom 5-DOF sensor embedded in the tip for tracking its position in real-time. The physician may use ultrasound for assistance in target visualization as well. Catheter deflections will be detected and corrected for in real-time by the radiation oncologist as the catheter is inserted into the patient during the procedure, this will occur when the EM system is in use.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fraction 3-Addition of EMN</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the second group of patients in the trial the same protocol will be followed as in the first group, the only difference will be that the electromagnetic navigation is used during the second implantation procedure immediately preceding fraction 3 as opposed to fraction 1, the time at which it was used for the first group of patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electromagnetic Navigation</intervention_name>
    <description>Electromagnetic navigation is a form of surgical navigation that can be incorporated into the cervical interstitial brachytherapy workflow to improve the current standards of guidance.</description>
    <arm_group_label>Fraction 1-Addition of EMN</arm_group_label>
    <arm_group_label>Fraction 3-Addition of EMN</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women diagnosed with FIGO stage IB2-IVA (locally advanced) cervical cancer being&#xD;
             treated with combined 3D interstitial / intracavitary HDR brachytherapy in 4 fractions&#xD;
             and concurrent chemotherapy&#xD;
&#xD;
          -  Minimum of 2 brachytherapy implantation procedures.&#xD;
&#xD;
          -  The Syed-Neblett applicator is indicated for use due to the extent/complexity of the&#xD;
             disease&#xD;
&#xD;
          -  Given informed consent to take part in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metastatic disease&#xD;
&#xD;
          -  Bilateral or unilateral hip prostheses&#xD;
&#xD;
          -  Pacemakers&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ananth Ravi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ananth Ravi, PhD</last_name>
    <phone>416 480 6100</phone>
    <phone_ext>1092</phone_ext>
    <email>ananth.ravi@sunnybrook.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ananth Ravi, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>March 16, 2020</last_update_submitted>
  <last_update_submitted_qc>March 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
    <investigator_full_name>Ananth Ravi</investigator_full_name>
    <investigator_title>Clinical Operations Lead of Brachytherapy</investigator_title>
  </responsible_party>
  <keyword>Interstitial Brachytherapy</keyword>
  <keyword>Electromagnetic tracking</keyword>
  <keyword>Implant quality</keyword>
  <keyword>Image guidance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Results will be made available to relevant stakeholders within the Odette Cancer Centre as these results may assist in the translation of this trial into routine clinical practice.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data will be made available within 6 months of study completion.</ipd_time_frame>
    <ipd_access_criteria>Data access requests external to the Odette Cancer Centre will be reviewed by the REB at Sunnybrook Health Science Centre prior to permitting access.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03781271
org study id: 143-2018
nct id: NCT03781271
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Phase I study evaluating the feasibility of using electromagnetic navigation (EMN) for the
      catheter implantation procedure required of cervical brachytherapy. The addition of EMN to
      the current HDR brachytherapy workflow has the potential to dramatically improve implant
      quality and efficiency for the gynecological interstitial brachytherapy program. Implant
      quality has been reported to be an important predictive factor for local control and late
      toxicity.
Cervical cancer poses a significant local and global health problem. In 2017 over 1,500
      Canadian women were predicted to develop cervical cancer, and another 400 were approximated
      to die from the disease. Cervical cancer rates have steadily decreased in developed nations
      largely due to regular gynaecological screening and public human papillomavirus vaccination
      programs; however, the disease accounts for up to 12% of all female cancer diagnoses in
      developing nations, and poses a disproportionate burden on aboriginal women across Canada.
      Much work needs to be done to address disparities in care and treatment for cervical cancer,
      both in Canada and worldwide.

      FIGO stage IA - IB1 is considered localized disease and treated primarily with surgery. In
      contrast to early stage disease, tumours that extend greater than 4 cm and beyond the cervix
      are considered locally advanced. The standard of care for locally advanced cervical cancer
      defined as FIGO stages IB2 - IVA is external beam radiation therapy with concurrent
      chemotherapy followed by brachytherapy.

      Brachytherapy is a crucial component of therapeutic management that has been shown to be
      associated with improved local control. High dose rate brachytherapy involves the treatment
      of local bulky disease using a remotely loaded Iridium-192 source. Brachytherapy delivery
      exploits rapid dose fall off, allowing for the central pelvis to receive a very high dose
      while sparing the bladder, rectum, sigmoid and small bowel. This dose escalation is beyond
      what is conventionally achievable using external radiation therapy methods. More
      specifically, image guided adaptive brachytherapy employing intracavitary applicators allows
      for dose optimization and improves target dose coverage for limited size tumours.

      Intracavitary applicators have been shown to be adequate from covering symmetric small
      tumours less than 30 cc. However, for large or complex asymmetric tumours with/without
      vaginal involvement they are not sufficient to cover the target while respecting normal
      tissue tolerances. To compensate for these limitations, improvements in local control have
      been achieved using a combined interstitial and intracavitary technique for larger tumours.
      Combined intracavitary - interstitial applicators have been designed to target tumours that
      are not adequately covered by intracavitary applicators alone. The addition of the
      interstitial technique involves the insertion of catheters into the tumour enabling higher
      dose conformity and normal tissue sparing. This combined technique has been shown in large
      tumours with extensive parametrial involvement as well as in cases with unfavourable
      topography to be effective. Employing this combined technique, perineal-based interstitial
      image guided adaptive brachytherapy makes it possible to deliver higher doses to the high
      risk clinical target volume without increasing dose to the bladder, rectum or sigmoid.

      The combined interstitial and intracavitary brachytherapy workflow for locally advanced
      cervical cancer at the Odette Cancer Centre typically consists of four treatment fractions.
      The workflow begins with a pre-brachytherapy assessment MRI that is taken before
      brachytherapy treatment to assist in preplanning of catheter depth and location. At the time
      of this MRI the patient will have a vaginal cylinder in place. 1-2 weeks after the MRI, the
      implant and treatment is performed. Prior to the implantation procedure, the patient is given
      light sedation and a spinal anesthetic, subsequently a vaginal cylinder (Best Medical
      Systems, Inc, Springfield VA) is inserted into the patient. A perineal template that contains
      a central opening is fit on the vaginal cylinder. The template is then advanced until it is
      appositional on the perineum of the patient. Plastic catheters (6F 24 cm) containing metal
      stylets are inserted through the template and along the grooves of the vaginal cylinder
      thereby penetrating the perineum and the vagina, respectively. The number, position and depth
      of the catheters that are used are based on the pre-brachytherapy assessment MRI. After the
      implantation procedure the template is sutured to the patient and the patient is transferred
      to an MRI suite where an image of her anatomy is acquired with the catheters and applicators
      in place. The patient is then sent for a CT scan that is to be used for treatment planning.

      Treatment planning involves the registration of the CT and MR datasets. The MR images are
      used to identify the soft tissue organs at risk and the targets. The CT is used to identify
      the catheters implanted in the patient. Using the knowledge of where the applicator/catheters
      are with respect to the targets and organs at risk, a dose distribution is designed to target
      the cancer while sparing normal tissue. On the same day as the implantation, one treatment
      fraction is delivered and the patient is admitted overnight. The next day the patient may as
      a standard of care, depending on the clinical indication undergo one or two additional
      fractions, separated by at least 6 hours. A week later the same process for the first two
      fractions will be repeated for the remaining two fractions.

      During the insertion of catheters, it has been recognized that they can converge or diverge
      as they pierce stiff tissues along the implantation path. Without proper image guidance, a
      template guided interstitial implant could result in an increase in risk of normal tissue
      complications. Real-time image guidance for catheter insertion is institution dependent, at
      the Odette Cancer Centre trans-abdominal ultrasound is used for placement of the tandem and
      more recently the trans-rectal ultrasound has been investigated for catheter placement. Other
      forms of real-time catheter guidance used at different centres include fluoroscopy, computed
      tomography (CT), and magnetic resonance imaging (MRI).

      The quality of interstitial brachytherapy implants has been reported to be an important
      predictive factor for local control and late toxicity. The quality of the implant is
      dependent on the geometry of the catheters, and real time image guidance for interstitial
      cervical brachytherapy is markedly lacking.

      At the Odette Cancer Centre, a four-patient study was conducted to characterize the amount of
      catheter deflection and angulation during gynaecological high-dose-rate interstitial
      brachytherapy. Results from this study demonstrated that the mean value of the maximum
      catheter deflection at the level of the GTV was 9.1 mm +/- 3.2 mm (range 3.0 - 18.4 mm) and
      can approach as much as 2 cm at the level of the GTV. Although the catheter deflection
      observed in this study did not result in any significant dosimetric impact the sample size
      was small and the authors of the study suggested that further investigation into real-time
      catheter guidance may be necessary into alleviating this deviation to prevent suboptimal plan
      quality.

      Electromagnetic tracking can minimize the uncertainties related to implant quality. The
      operation of an electromagnetic tracking device depends on a field generator producing a
      magnetic field that extends across the anatomy of interest. The tracked sensor in this system
      induces a distance-dependent voltage that is used to determine the spatial position of the
      sensor within the volume of interest. This technology is extensively used in clinical
      practice, examples include, surgical interventions, guidance of biopsies, and motion
      monitoring.

      Electromagnetic navigation can be incorporated into the cervical interstitial brachytherapy
      workflow as a form of real-time catheter guidance. By incorporating this guidance into the
      current workflow it is possible that a higher degree of accuracy in catheter placement will
      be achieved when used in conjunction with image-guided brachytherapy. This study seeks to
      evaluate the efficacy of electromagnetic navigation on the perineal-based interstitial cervix
      image-guided brachytherapy workflow as part of a phase I clinical trial.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: 2 arms of patients will undergo standard routine brachytherapy treatment. A part of the treatment involves the placement of catheters. For both arms of the study the placement of these catheters will be assisted by an electromagnetic navigation system. The difference between the arms will be that the navigation system will be used at different times in the course of their brachytherapy treatment to eliminate bias. One group will undergo electromagnetic navigation assisted catheter placement during their first fraction of treatment while the second arm will undergo electromagnetic navigation assisted catheter placement during their third fraction of treatment.
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Treatment Plan Target Volume and Organs at Risk Dosimetry
time frame: 14 days
description: The treatment plans generated during the course of treatment for participants will be evaluated. The evaluation of the treatment plans will use the dose received by specific target structures and the dose received by structures that are defined as organs at risk. The specific metric that will be used represents how much dose is received by a certain percentage of a volume. For example, the D98 GTV refers to how much dose is received by 98 percent of the gross tumour volume. The dose is a value that is measured in the unit, Gray. In addition to the dose constraint for the D98 GTV the other dose constraints that will be used for evaluation purposes are, D90 HR-CTV, D98 HR-CTV, D98 IR-CTV and OAR constraints. A significance level of 5% will be used to identify differences between the dose constraints for treatment plans that are generated when EMN is used and when EMN is not used.
arm group label: Fraction 1-Addition of EMN
arm group type: Experimental
description: During the fraction 1 insertion, the custom MRI-compatible vaginal cylinder will be placed in the patient, and will contain the 6 degree-of-freedom (DOF) sensor. The electromagnetic navigation system and computer will have been setup in the operating room (OR) prior to the procedure and will be used to actively insert up to 25 catheters into the target. The catheters will be inserted using a custom metallic stylet that has a custom 5-DOF sensor embedded in the tip for tracking its position in real-time. The physician may use ultrasound for assistance in target visualization as well. Catheter deflections will be detected and corrected for in real-time by the radiation oncologist as the catheter is inserted into the patient during the procedure, this will occur when the EM system is in use.
arm group label: Fraction 3-Addition of EMN
arm group type: Experimental
description: For the second group of patients in the trial the same protocol will be followed as in the first group, the only difference will be that the electromagnetic navigation is used during the second implantation procedure immediately preceding fraction 3 as opposed to fraction 1, the time at which it was used for the first group of patients.
intervention type: Device
intervention name: Electromagnetic Navigation
description: Electromagnetic navigation is a form of surgical navigation that can be incorporated into the cervical interstitial brachytherapy workflow to improve the current standards of guidance.
arm group label: Fraction 1-Addition of EMN
arm group label: Fraction 3-Addition of EMN
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ananth Ravi, PhD
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
last name: Ananth Ravi, PhD
phone: 416 480 6100
phone ext: 1092
email: ananth.ravi@sunnybrook.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Sunnybrook Health Sciences Centre
investigator full name: Ananth Ravi
investigator title: Clinical Operations Lead of Brachytherapy
mesh term: Uterine Cervical Neoplasms
sharing ipd: Yes
ipd description: Results will be made available to relevant stakeholders within the Odette Cancer Centre as these results may assist in the translation of this trial into routine clinical practice.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data will be made available within 6 months of study completion.
ipd access criteria: Data access requests external to the Odette Cancer Centre will be reviewed by the REB at Sunnybrook Health Science Centre prior to permitting access.