<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/NCT04497051</url>
  </required_header>
  <id_info>
    <org_study_id>202001028RINB</org_study_id>
    <nct_id>NCT04497051</nct_id>
  </id_info>
  <brief_title>CT-DSA Evaluation of Embolization in Debulking Spinal Surgery</brief_title>
  <official_title>Using CT-DSA With Deformable Registration Technique to Predict Efficacy in Preoperative Embolization for Spinal Metastasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      Vertebra is one of the most common site of metastatic disease, which may cause severe pain or&#xD;
      neurological deficit. Decompressive surgery or radiation therapy are of limited efficacy and&#xD;
      recurrence is very likely. Debulking surgery usually has better local control and survival&#xD;
      benefit. However, debulking surgery often accompany with massive blood loss, which may cause&#xD;
      hemorrhagic shock or death. It is known that intraoperative blood loss is associated with&#xD;
      tumoral vascularity. However, there is current no objective method to evaluate vascularity&#xD;
      status. On the other hand, preoperative embolization is considered as major method to&#xD;
      decrease blood loss. There is also objective method to evaluate the embolization effect. By&#xD;
      our innovative dual energy computed tomography angiography - digital subtraction angiography&#xD;
      (CT-DSA), the tumoral vascularity status and embolization effect of spinal tumor can be&#xD;
      objectively assessed. We aim to utilize CT-DSA to investigate spinal tumor, in a hope to find&#xD;
      out correlation of vascularity status, embolization method, and surgical outcome, which can&#xD;
      help individual disease status and tailored treatment decision.&#xD;
&#xD;
      Key word: spine/embolization/computed tomography&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vertebral osseus metastasis, can cause neoplastic spinal cord compression and neurological&#xD;
      deficit. The treatment strategy depend on the pathological type, performance status, and life&#xD;
      expectancy. The goal of treatment is to avoid neurological deterioration, to keep functional&#xD;
      life, and to control bone pain. Treatment strategy involve multidisciplinary approaches&#xD;
      between spinal surgeon, medical and radiation oncologist, and radiologist. When presence of&#xD;
      acute neurological deterioration or intractable pain due to neoplastic compression or&#xD;
      vertebral instability, surgical approach is often warranted. In term of surgical approach,&#xD;
      simple decompression and fixation is often applied, but the long-term control rate is&#xD;
      suboptimal. Aggressive spinal surgery, including extensive debulking surgery or&#xD;
      spondylectomy, has relative longstanding effect to maintain neurological and oncological&#xD;
      outcome.&#xD;
&#xD;
      Despite relative good outcome of aggressive spinal surgery, it is a relative massive&#xD;
      procedure in which life-threatening blood loss commonly occur. To achieve better surgical&#xD;
      outcome and decrease complication, preoperative embolization is suggested to control blood&#xD;
      loss . The procedure is performed by an interventional radiologist to deliver embolic agent&#xD;
      into vascular pedicles of target vertebra, in hope to achieve optimal devascularization of&#xD;
      the tumour. The concept is simple and the similar procedure has been performed thousands of&#xD;
      times in the world. However, its efficacy and utilization are not yet proven by clinical&#xD;
      trials. When and how to perform this procedure largely depends on experience of operating&#xD;
      interventional radiologist.&#xD;
&#xD;
      CT is an important imaging tool for spinal disease. Because of its rapid acquisition,&#xD;
      adequate resolution, and easy reformatting, it is optimal for intolerable patients.&#xD;
      Nevertheless, osseous structure is extremely radiopaque, evaluation of tumoral enhancement in&#xD;
      vertebrae is not easy. Nevertheless, the enhancement of osseous tumour can be evaluated with&#xD;
      advanced subtraction reformatting technique. The technique is similar to digital subtraction&#xD;
      angiography (DSA) of catheter angiography, and we call it CT-DSA image. As compared with&#xD;
      traditional catheter-based DSA, CT-DSA has following additional advantages: 1)&#xD;
      non-invasiveness; 2) non-selective enhancement of the target; 3) allowing multiplanar&#xD;
      reformatting and additional post-processing and quantification. The tool is very versatile to&#xD;
      investigate the vascularity of the vertebral neoplasm. In our earlier result, we found the&#xD;
      CT-DSA has good correlation with DSA in vascularity assessment, suggestive of its utilization&#xD;
      in pre-operative and pre-embolization evaluation of spinal tumour. It can be used in&#xD;
      semi-quntitative and quantitative fashion.&#xD;
&#xD;
      Traditionally, the efficacy of embolization is determined by surgical outcome, usually with&#xD;
      gold standard of blood loss. However, blood loss is determined by many different factors,&#xD;
      including tumor volume, surgical technique, and other anatomical factors. Using CT-DSA,&#xD;
      evaluation of the embolization effect directly is possible. As the study can be repeated&#xD;
      after embolization, the interval change can be observed with objective measurement.&#xD;
&#xD;
      In summary, using CT-DSA, it is possible to evaluate the vascularity of the osseous tumour&#xD;
      and efficacy of devascularization after embolization before surgery. We can therefore design&#xD;
      study to test efficacy of different intervention strategy, and find out the more beneficial&#xD;
      indication, which can incorporate into clinical workflow and help patients.&#xD;
&#xD;
      Purpose&#xD;
&#xD;
        1. The establish subjective risk classification of debulking surgery in term of tumour&#xD;
           vascularity&#xD;
&#xD;
        2. To subjectively evaluate efficacy of preoperative embolization&#xD;
&#xD;
        3. To design appropriate clinical workflow in management of patient with vertebral&#xD;
           malignancy&#xD;
&#xD;
      Importance Vertebrae is 3rd most common site of metastatic malignancy, and is usually warrant&#xD;
      aggressive spinal surgery. Since preoperative embolization is commonly done in this patient,&#xD;
      it needs subjective tool to assess its efficacy and clear indication. By using CT-DSA, there&#xD;
      is potential to provide tailored strategy of patient management before surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">March 29, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 29, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>estimated blood loss during surgery</measure>
    <time_frame>24 hours</time_frame>
    <description>blood lose in debulking spinal surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>transfusion amount</measure>
    <time_frame>24 hours</time_frame>
    <description>perioperative blood transfusion</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Spinal Metastases</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Embolized patients</arm_group_label>
    <description>subjects receiving preoperative embolization for aggressive spinal debulking surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CT-DSA</intervention_name>
    <description>CTA before and after embolization</description>
    <arm_group_label>Embolized patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with clinical diagnosis for thoracolumbar vertebral malignancy who can receive&#xD;
        preoperative emoblization&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient with clinical diagnosis for thoracolumbar vertebral primary or metastatic&#xD;
             malignancy&#xD;
&#xD;
          2. Eligible for aggressive spinal surgery, including debulking and en bloc spondylectomy&#xD;
&#xD;
          3. Life expectancy more than 6 months&#xD;
&#xD;
          4. Serum creatinine less than 1.5 mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age less than 20 year old&#xD;
&#xD;
          2. Woman in pregnancy or breast feeding&#xD;
&#xD;
          3. Serious allergic reaction to contrast medium&#xD;
&#xD;
          4. Instable neurological condition warrant urgent operation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Yen-Heng Lin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yen-Heng Lin, MD</last_name>
    <phone>886-02-23123456</phone>
    <phone_ext>62570</phone_ext>
    <email>cryhungry@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yen-Heng Lin, MD</last_name>
      <email>cryhungry@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Fon-Yih Tsuang, MD, PhD</last_name>
      <email>tsuangfy@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Fon-Yih Tsuang, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vertebra</keyword>
  <keyword>embolization</keyword>
  <keyword>surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <!-- 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/NCT04497051
org study id: 202001028RINB
nct id: NCT04497051
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Vertebra is one of the most common site of metastatic disease, which may cause severe pain or
      neurological deficit. Decompressive surgery or radiation therapy are of limited efficacy and
      recurrence is very likely. Debulking surgery usually has better local control and survival
      benefit. However, debulking surgery often accompany with massive blood loss, which may cause
      hemorrhagic shock or death. It is known that intraoperative blood loss is associated with
      tumoral vascularity. However, there is current no objective method to evaluate vascularity
      status. On the other hand, preoperative embolization is considered as major method to
      decrease blood loss. There is also objective method to evaluate the embolization effect. By
      our innovative dual energy computed tomography angiography - digital subtraction angiography
      (CT-DSA), the tumoral vascularity status and embolization effect of spinal tumor can be
      objectively assessed. We aim to utilize CT-DSA to investigate spinal tumor, in a hope to find
      out correlation of vascularity status, embolization method, and surgical outcome, which can
      help individual disease status and tailored treatment decision.

      Key word: spine/embolization/computed tomography
Vertebral osseus metastasis, can cause neoplastic spinal cord compression and neurological
      deficit. The treatment strategy depend on the pathological type, performance status, and life
      expectancy. The goal of treatment is to avoid neurological deterioration, to keep functional
      life, and to control bone pain. Treatment strategy involve multidisciplinary approaches
      between spinal surgeon, medical and radiation oncologist, and radiologist. When presence of
      acute neurological deterioration or intractable pain due to neoplastic compression or
      vertebral instability, surgical approach is often warranted. In term of surgical approach,
      simple decompression and fixation is often applied, but the long-term control rate is
      suboptimal. Aggressive spinal surgery, including extensive debulking surgery or
      spondylectomy, has relative longstanding effect to maintain neurological and oncological
      outcome.

      Despite relative good outcome of aggressive spinal surgery, it is a relative massive
      procedure in which life-threatening blood loss commonly occur. To achieve better surgical
      outcome and decrease complication, preoperative embolization is suggested to control blood
      loss . The procedure is performed by an interventional radiologist to deliver embolic agent
      into vascular pedicles of target vertebra, in hope to achieve optimal devascularization of
      the tumour. The concept is simple and the similar procedure has been performed thousands of
      times in the world. However, its efficacy and utilization are not yet proven by clinical
      trials. When and how to perform this procedure largely depends on experience of operating
      interventional radiologist.

      CT is an important imaging tool for spinal disease. Because of its rapid acquisition,
      adequate resolution, and easy reformatting, it is optimal for intolerable patients.
      Nevertheless, osseous structure is extremely radiopaque, evaluation of tumoral enhancement in
      vertebrae is not easy. Nevertheless, the enhancement of osseous tumour can be evaluated with
      advanced subtraction reformatting technique. The technique is similar to digital subtraction
      angiography (DSA) of catheter angiography, and we call it CT-DSA image. As compared with
      traditional catheter-based DSA, CT-DSA has following additional advantages: 1)
      non-invasiveness; 2) non-selective enhancement of the target; 3) allowing multiplanar
      reformatting and additional post-processing and quantification. The tool is very versatile to
      investigate the vascularity of the vertebral neoplasm. In our earlier result, we found the
      CT-DSA has good correlation with DSA in vascularity assessment, suggestive of its utilization
      in pre-operative and pre-embolization evaluation of spinal tumour. It can be used in
      semi-quntitative and quantitative fashion.

      Traditionally, the efficacy of embolization is determined by surgical outcome, usually with
      gold standard of blood loss. However, blood loss is determined by many different factors,
      including tumor volume, surgical technique, and other anatomical factors. Using CT-DSA,
      evaluation of the embolization effect directly is possible. As the study can be repeated
      after embolization, the interval change can be observed with objective measurement.

      In summary, using CT-DSA, it is possible to evaluate the vascularity of the osseous tumour
      and efficacy of devascularization after embolization before surgery. We can therefore design
      study to test efficacy of different intervention strategy, and find out the more beneficial
      indication, which can incorporate into clinical workflow and help patients.

      Purpose

        1. The establish subjective risk classification of debulking surgery in term of tumour
           vascularity

        2. To subjectively evaluate efficacy of preoperative embolization

        3. To design appropriate clinical workflow in management of patient with vertebral
           malignancy

      Importance Vertebrae is 3rd most common site of metastatic malignancy, and is usually warrant
      aggressive spinal surgery. Since preoperative embolization is commonly done in this patient,
      it needs subjective tool to assess its efficacy and clear indication. By using CT-DSA, there
      is potential to provide tailored strategy of patient management before surgery.
observational model: Cohort
time perspective: Prospective
measure: estimated blood loss during surgery
time frame: 24 hours
description: blood lose in debulking spinal surgery
measure: transfusion amount
time frame: 24 hours
description: perioperative blood transfusion
arm group label: Embolized patients
description: subjects receiving preoperative embolization for aggressive spinal debulking surgery
intervention type: Diagnostic Test
intervention name: CT-DSA
description: CTA before and after embolization
arm group label: Embolized patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
last name: Yen-Heng Lin, MD
role: Principal Investigator
affiliation: National Taiwan University Hospital
last name: Yen-Heng Lin, MD
phone: 886-02-23123456
phone ext: 62570
email: cryhungry@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Neoplasm Metastasis