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The Effects of Radiation in Reconstructed Breasts

Abramson Cancer Center at Penn Medicine logo

Abramson Cancer Center at Penn Medicine

Status

Completed

Conditions

Breast Cancer

Treatments

Procedure: contract-enhanced MRI
Radiation: Unilateral Adjuvant Radiation Therapy

Study type

Observational

Funder types

Other

Identifiers

NCT01292772
UPCC 12110

Details and patient eligibility

About

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

Full 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.

Enrollment

12 patients

Sex

Female

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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