The Effects of Radiation in Reconstructed Breasts

The Effects of Radiation Therapy on the Reconstructed Breast: An Evaluation Using MR Imaging

The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant radiation therapy on reconstructed breasts.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: contract-enhanced MRI; Radiation: Unilateral Adjuvant Radiation Therapy

Detailed Description

Immediate breast reconstruction following mastectomy has become an increasingly popular and accepted treatment option among breast cancer patients. This change in practice has resulted in a significant number of patients who undergo radiation therapy after breast reconstruction. Following irradiation, the reconstructed breast often experiences fibrotic contracture, volume loss, altered pigmentation, or some combination thereof, producing an asymmetric and aesthetically compromised result. The effects of radiation on reconstructed breasts as well as the implications that such changes have for timing of reconstructive surgery, post-operative management and surveillance imaging are topics of growing importance in plastic surgery, radiology and surgical oncology.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The target population will consist of patients with a diagnosis of unilateral breast cancer who elect to undero bilateral mastectomy with immediate free flap reconstruction. Patients will be treated by members of the Division of Plastic and Reconstructive Surgery and will receive postoperative radiation therapy to the affected breast.

Description

Inclusion Criteria:

• Female patients between 18 and 90 years of age.
• Patients with a diagnosis of unilateral breast cancer who elect to undergo bilateral mastectomy with immediate free flap reconstruction.
• Patients must also have a locally advanced tumor that requires adjuvant radiation therapy following reconstruction.

Exclusion Criteria:

• Women who do not undergo immediate, bilateral breast reconstruction using a free flap.
• Women who do not require unilateral, adjuvant radiation therapy
• Women who are pregnant
• Women who have altered renal function, defined as a personal history of diabetic, hypertensive or autoimmune nephropathy and/or on routine preoperative testing are found to have a serum creatinine greater than or equal to 1.3

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reconstructed Breast Volume	This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.	up to 1 year after radiation
Vascular Fibrosis	This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.	up to 1 year after radiation
Dermal Thickness	This will be compared at 2 pionts: before radiation and 1 year after radiation is completed between the 2 breasts	up to 1 year after radiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Fat Necrosis in the Breast	This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.	up to 1 year after radiation
Evidence of Cancer Recurrence	This will assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.	up to 1 year after radiation
Symmetry	This will be assessed at 2 points; before radiation and 1 year after radiation is completed between the 2 breasts.	up to 1 year after radiation
Hyperpigmentation	This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.	up to 1 year after radiation
Contracture	This will be assessed at 2 points:before radiation and 1 year after radiation is completed between the 2 breasts.	up to 1 year after radiation
Aesthetic Result	This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.	up to 1 year after radiation

Collaborators and Investigators

• Sponsor: Abramson Cancer Center of the University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2010
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): May 5, 2019

Study Registration Dates

• First Submitted: February 1, 2011
• First Submitted That Met QC Criteria: February 9, 2011
• First Posted (Estimate): February 10, 2011

Study Record Updates

• Last Update Posted (Actual): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: breast cancer; immediate breast reconstruction; bilateral mastectomy; locally advanced unilateral breast cancer; bilateral mastectomy for prophylaxis
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: UPCC 12110