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Effect of Radiation on Tissue for Delayed Breast Reconstruction

18 Years
75 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Effect of Radiation on Tissue for Delayed Breast Reconstruction

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.

Inclusion Criteria:

1. Patients with invasive breast cancer who will require mastectomy and postmastectomy
radiation therapy.

2. Patients who meet criteria 1, who plan on postmastectomy breast reconstruction

Exclusion Criteria:

1. Male patients

2. Patients under the age of 18

3. Patients of advanced age (greater than 75)

4. Patients with comorbidities that affect wound healing.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

To evaluate cellular and histologic changes in mastectomy skin over time following completion of radiation therapy.

Outcome Time Frame:

2, 4, 6, 8, 12 months post radition therapy; 3, 6, 12 months post reconstruction

Safety Issue:


Principal Investigator

Adeyiza Momoh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Univeristy of Michigan


United States: Institutional Review Board

Study ID:




Start Date:

October 2012

Completion Date:

September 2015

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



University of Michigan Ann Arbor, Michigan  48109-0624