<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/NCT01666899</url>
  </required_header>
  <id_info>
    <org_study_id>2012.032</org_study_id>
    <secondary_id>HUM00059038</secondary_id>
    <nct_id>NCT01666899</nct_id>
  </id_info>
  <brief_title>Effect of Radiation on Tissue for Delayed Breast Reconstruction</brief_title>
  <official_title>Effect of Radiation on Tissue for Delayed Breast Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan Rogel Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan Rogel Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to investigate the effects of radiation therapy following&#xD;
      mastectomy on skin and blood vessels and to use information gathered to determine an ideal&#xD;
      time for breast reconstruction after radiation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the setting of post-mastectomy radiation therapy delayed autologous reconstruction,&#xD;
      favored by many attempts to avoid complications encountered with radiating the immediately&#xD;
      reconstructed breast. The timing of delayed reconstruction is however not known. The goal of&#xD;
      this proposal is to study the gross, structural and vascular changes in radiated mastectomy&#xD;
      skin in addition to possible structural and flow changes of the underlying internal mammary&#xD;
      vessels over time. We plan to use these objective findings as a basis for determining an&#xD;
      ideal time frame for delayed autologous breast reconstruction.&#xD;
&#xD;
      Sequential mastectomy skin specimens will be obtained from 20 patients undergoing&#xD;
      post-mastectomy radiation therapy over a 24 month period and these specimens will be&#xD;
      evaluated histologically. These same patients will also undergo serial examinations and&#xD;
      photographic documentation of gross skin changes. Skin perfusion will be assessed by laser&#xD;
      Doppler imaging and internal mammary vessel structure, and flow characteristics will be&#xD;
      assessed by color Doppler sonography.&#xD;
&#xD;
      Based on these studies, we will elucidate short and long term changes in radiated breast&#xD;
      skin, showing inflammatory, structural and perfusion patterns that can be correlated with&#xD;
      optimal conditions for reconstruction. This has the potential to dramatically change practice&#xD;
      patterns of delayed reconstruction for many reconstructive surgeons and more importantly&#xD;
      restore what patients loose with mastectomy in a consistent, timely fashion. There is also&#xD;
      potential for improved outcomes of delayed breast reconstruction by decreasing the number of&#xD;
      reconstructions performed too soon after completion of radiation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 15, 2015</completion_date>
  <primary_completion_date type="Actual">June 15, 2015</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate cellular and histologic changes in mastectomy skin over time following completion of radiation therapy.</measure>
    <time_frame>2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the vascular density of the skin and perfusion changes following radiation therapy.</measure>
    <time_frame>2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>To evaluate changes in internal mammary vessel structure and flow characteristics over time following completion of radiation therapy.</measure>
    <time_frame>2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Skin and blood vessel procedures</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will be placed into Arm 1. They will undergo punch biopsies of the breast skin at the time of mastectomy and at 2, 4, 6, 8 and 12 months after completion of radiation therapy. Three more biopsies will be taken at 3, 6, and 12 months after completion of reconstruction. Patients will also undergo skin blood flow studies with a laser imaging device prior to each biopsy procedure. Ultrasound studies of the chest vessels will be performed 4 times over the course of the study- once prior to radiation and at 2, 6 and 12 months after radiation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Skin and blood vessel procedures</intervention_name>
    <description>Biopsies, skin blood flow studies and ultrasound studies will be performed as described.</description>
    <arm_group_label>Skin and blood vessel procedures</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with invasive breast cancer who will require mastectomy and postmastectomy&#xD;
             radiation therapy.&#xD;
&#xD;
          2. Patients who meet criteria 1, who plan on postmastectomy breast reconstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Male patients&#xD;
&#xD;
          2. Patients under the age of 18&#xD;
&#xD;
          3. Patients of advanced age (greater than 75)&#xD;
&#xD;
          4. Patients with comorbidities that affect wound healing.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adeyiza Momoh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univeristy of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>May 24, 2017</last_update_submitted>
  <last_update_submitted_qc>May 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01666899
org study id: 2012.032
secondary id: HUM00059038
nct id: NCT01666899
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the effects of radiation therapy following
      mastectomy on skin and blood vessels and to use information gathered to determine an ideal
      time for breast reconstruction after radiation.
In the setting of post-mastectomy radiation therapy delayed autologous reconstruction,
      favored by many attempts to avoid complications encountered with radiating the immediately
      reconstructed breast. The timing of delayed reconstruction is however not known. The goal of
      this proposal is to study the gross, structural and vascular changes in radiated mastectomy
      skin in addition to possible structural and flow changes of the underlying internal mammary
      vessels over time. We plan to use these objective findings as a basis for determining an
      ideal time frame for delayed autologous breast reconstruction.

      Sequential mastectomy skin specimens will be obtained from 20 patients undergoing
      post-mastectomy radiation therapy over a 24 month period and these specimens will be
      evaluated histologically. These same patients will also undergo serial examinations and
      photographic documentation of gross skin changes. Skin perfusion will be assessed by laser
      Doppler imaging and internal mammary vessel structure, and flow characteristics will be
      assessed by color Doppler sonography.

      Based on these studies, we will elucidate short and long term changes in radiated breast
      skin, showing inflammatory, structural and perfusion patterns that can be correlated with
      optimal conditions for reconstruction. This has the potential to dramatically change practice
      patterns of delayed reconstruction for many reconstructive surgeons and more importantly
      restore what patients loose with mastectomy in a consistent, timely fashion. There is also
      potential for improved outcomes of delayed breast reconstruction by decreasing the number of
      reconstructions performed too soon after completion of radiation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: To evaluate cellular and histologic changes in mastectomy skin over time following completion of radiation therapy.
time frame: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
measure: To evaluate the vascular density of the skin and perfusion changes following radiation therapy.
time frame: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
measure: To evaluate changes in internal mammary vessel structure and flow characteristics over time following completion of radiation therapy.
time frame: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
arm group label: Skin and blood vessel procedures
arm group type: Experimental
description: All patients will be placed into Arm 1. They will undergo punch biopsies of the breast skin at the time of mastectomy and at 2, 4, 6, 8 and 12 months after completion of radiation therapy. Three more biopsies will be taken at 3, 6, and 12 months after completion of reconstruction. Patients will also undergo skin blood flow studies with a laser imaging device prior to each biopsy procedure. Ultrasound studies of the chest vessels will be performed 4 times over the course of the study- once prior to radiation and at 2, 6 and 12 months after radiation.
intervention type: Procedure
intervention name: Skin and blood vessel procedures
description: Biopsies, skin blood flow studies and ultrasound studies will be performed as described.
arm group label: Skin and blood vessel procedures
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Adeyiza Momoh, MD
role: Principal Investigator
affiliation: Univeristy of Michigan
facility: 
country: United States
responsible party type: Sponsor