Effect of Radiation on Tissue for Delayed Breast Reconstruction
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Effect of Radiation on Tissue for Delayed Breast Reconstruction|
- 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 radition therapy; 3, 6, 12 months post reconstruction ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: 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.
Procedure: Skin and blood vessel procedures
Biopsies, skin blood flow studies and ultrasound studies will be performed as described.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666899
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Adeyiza Momoh, MD||Univeristy of Michigan|