The Effects of Radiation in Reconstructed Breasts

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2019-05-05

Brief Summary

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

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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contract-enhanced MRI

Patients will have contrast-enhanced MRI of the breasts.

Intervention Type PROCEDURE

Unilateral Adjuvant Radiation Therapy

The study group will consist breasts receiving post-operative radiation, and the control group will consist of the patient's breasts on the non-radiated side. In this way, patients will act as their own control.

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No