Effect of Radiation on Tissue for Delayed Breast Reconstruction
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
To evaluate cellular and histologic changes in mastectomy skin over time following completion of radiation therapy.
時間枠：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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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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To evaluate the vascular density of the skin and perfusion changes following radiation therapy.
時間枠：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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その他の成果指標
結果測定 |
時間枠 |
|---|---|
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To evaluate changes in internal mammary vessel structure and flow characteristics over time following completion of radiation therapy.
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Adeyiza Momoh, MD、Univeristy of Michigan
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2012.032
- HUM00059038 (その他の識別子：University of Michigan Medical School IRB)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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