Effect of Radiation on Tissue for Delayed Breast Reconstruction
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- University of Michigan
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with invasive breast cancer who will require mastectomy and postmastectomy radiation therapy.
- Patients who meet criteria 1, who plan on postmastectomy breast reconstruction
Exclusion Criteria:
- Male patients
- Patients under the age of 18
- Patients of advanced age (greater than 75)
- Patients with comorbidities that affect wound healing.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Skin and blood vessel procedures
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.
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Biopsies, skin blood flow studies and ultrasound studies will be performed as described.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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To evaluate cellular and histologic changes in mastectomy skin over time following completion of radiation therapy.
기간: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
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2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
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2차 결과 측정
결과 측정 |
기간 |
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To evaluate the vascular density of the skin and perfusion changes following radiation therapy.
기간: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
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2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
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기타 결과 측정
결과 측정 |
기간 |
|---|---|
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To evaluate changes in internal mammary vessel structure and flow characteristics over time following completion of radiation therapy.
기간: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
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2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
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공동 작업자 및 조사자
수사관
- 수석 연구원: Adeyiza Momoh, MD, Univeristy of Michigan
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2012.032
- HUM00059038 (기타 식별자: University of Michigan Medical School IRB)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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