<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/NCT03801850</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01</org_study_id>
    <secondary_id>2017-A02489-44</secondary_id>
    <nct_id>NCT03801850</nct_id>
  </id_info>
  <brief_title>Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: MorphoBreast3D</brief_title>
  <acronym>MB3D</acronym>
  <official_title>Quantitative Evaluation of the Breast's Morphological Variations During Radiotherapy: Monocentric Feasibility Study MorphoBreast3D</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Paul Strauss</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Paul Strauss</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>
      Quantitative evaluation of the breast's morphological variations during radiotherapy&#xD;
      consisting in performing three-dimensional surface acquisitions of the breast in order to&#xD;
      study its shape and volume. Evaluation of the dosimetric impact of these variations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2018</start_date>
  <completion_date type="Actual">May 7, 2020</completion_date>
  <primary_completion_date type="Actual">May 7, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of breast morphology or volume changes during the breast irradiation on the total dose administered</measure>
    <time_frame>Change of the dose delivered in the breast from the baseline treatment planification at the end of the treatment (at 5 weeks for in-situ carcinoma and at 6.5 weeks for invasive carcinoma)</time_frame>
    <description>To analyse the effect of morphological changes in the breast during breast radiotherapy on the dose really administered in the remaining mammary gland after breast-conserving surgery compared to the dose initially planned.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preliminary quantitative assessment of breast volume changes (mL) during breast radiotherapy following breast cancer conservative surgery</measure>
    <time_frame>At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preliminary quantitative assessment of breast deformations (mm) during breast radiotherapy following breast cancer conservative surgery</measure>
    <time_frame>At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breast deformation and volume measurements reproducibility</measure>
    <time_frame>before treatment start</time_frame>
    <description>Evaluation of the reproducibility of deformation and volume measurements between 2 consecutive surface scan acquisition. Reproducibility was calculated in accordance with International Organization of Standardisation (ISO 5725-2) and American Society for Testing and Material E177</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deviation between the breast volume calculated and the breast volume manually delineated</measure>
    <time_frame>before treatment start</time_frame>
    <description>Evaluation of the difference between the initial breast volume calculated by the software developed for the study and the delineated volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Required measurement time (surface scan)</measure>
    <time_frame>At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)</time_frame>
    <description>Mean time (in minutes) needed to perform a surface scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between textural data and radio-induced erythema</measure>
    <time_frame>At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential dose distribution alteration despite no variation of the 95Recalculated or the D2Recalculated</measure>
    <time_frame>at the end of each treatment (at 5 weeks for in-situ carcinoma and at 6.5 weeks for invasive carcinoma)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Breast Cancer Female</condition>
  <condition>Adjuvant Radiotherapy</condition>
  <arm_group>
    <arm_group_label>observational cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D surface scan</intervention_name>
    <description>measurement of inter fractional deformations by surface scanning</description>
    <arm_group_label>observational cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women&#xD;
&#xD;
          -  In situ or invasive breast carcinoma&#xD;
&#xD;
          -  Treated by conservative breast surgery&#xD;
&#xD;
          -  Pre-treatment with authorized chemotherapy&#xD;
&#xD;
          -  Eligible for conventional breast irradiation in 25 sessions of 2 Gy with or without&#xD;
             irradiation of the tumor bed and lymph nodes area&#xD;
&#xD;
          -  Conventional 3D radiotherapy technique&#xD;
&#xD;
          -  Bra cup size from A to D included&#xD;
&#xD;
          -  Speaking and understanding french&#xD;
&#xD;
          -  Having given written consent&#xD;
&#xD;
          -  Patient with health insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Surgical treatment by mastectomy&#xD;
&#xD;
          -  No indication for breast radiotherapy&#xD;
&#xD;
          -  Local or diffuse inflammatory state of the breast at inclusion&#xD;
&#xD;
          -  History of epilepsy or anticonvulsive treatment for preventive or curative purposes&#xD;
&#xD;
          -  BMI&gt; 30kg / m2&#xD;
&#xD;
          -  T4 stage tumor&#xD;
&#xD;
          -  Bilateral breast tumor&#xD;
&#xD;
          -  Use of a ventilatory control to treat the patient&#xD;
&#xD;
          -  Minor patient or major incompetent&#xD;
&#xD;
          -  Patient deprived of liberty&#xD;
&#xD;
          -  Patient under safeguard of justice&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Georges NOEL, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Paul Strauss</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre paul Strauss</name>
      <address>
        <city>Strasbourg</city>
        <zip>67065</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>volume variation</keyword>
  <keyword>deformation</keyword>
  <keyword>repositioning</keyword>
  <keyword>dosimetric quality</keyword>
  <keyword>3D scan</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03801850
org study id: 2018-01
secondary id: 2017-A02489-44
nct id: NCT03801850
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Quantitative evaluation of the breast's morphological variations during radiotherapy
      consisting in performing three-dimensional surface acquisitions of the breast in order to
      study its shape and volume. Evaluation of the dosimetric impact of these variations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Impact of breast morphology or volume changes during the breast irradiation on the total dose administered
time frame: Change of the dose delivered in the breast from the baseline treatment planification at the end of the treatment (at 5 weeks for in-situ carcinoma and at 6.5 weeks for invasive carcinoma)
description: To analyse the effect of morphological changes in the breast during breast radiotherapy on the dose really administered in the remaining mammary gland after breast-conserving surgery compared to the dose initially planned.
measure: Preliminary quantitative assessment of breast volume changes (mL) during breast radiotherapy following breast cancer conservative surgery
time frame: At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)
measure: Preliminary quantitative assessment of breast deformations (mm) during breast radiotherapy following breast cancer conservative surgery
time frame: At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)
measure: Breast deformation and volume measurements reproducibility
time frame: before treatment start
description: Evaluation of the reproducibility of deformation and volume measurements between 2 consecutive surface scan acquisition. Reproducibility was calculated in accordance with International Organization of Standardisation (ISO 5725-2) and American Society for Testing and Material E177
measure: Deviation between the breast volume calculated and the breast volume manually delineated
time frame: before treatment start
description: Evaluation of the difference between the initial breast volume calculated by the software developed for the study and the delineated volume
measure: Required measurement time (surface scan)
time frame: At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)
description: Mean time (in minutes) needed to perform a surface scan
measure: Correlation between textural data and radio-induced erythema
time frame: At 1, 5, 12, 19, 26, 33 and 43 days from the start of the treatment (corresponding to the fraction number 1, 5, 10, 15, 20, 25, 33)
measure: Potential dose distribution alteration despite no variation of the 95Recalculated or the D2Recalculated
time frame: at the end of each treatment (at 5 weeks for in-situ carcinoma and at 6.5 weeks for invasive carcinoma)
arm group label: observational cohort
arm group type: Experimental
intervention type: Device
intervention name: 3D surface scan
description: measurement of inter fractional deformations by surface scanning
arm group label: observational cohort
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Georges NOEL, MD PhD
role: Principal Investigator
affiliation: Centre Paul Strauss
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided