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


N/A
18 Years
90 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Reconstructed Breast Volume

Outcome Description:

This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.

Outcome Time Frame:

up to 1 year after radiation

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

UPCC 12110

NCT ID:

NCT01292772

Start Date:

December 2010

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • breast cancer
  • bilateral mastectomy
  • immediate breast reconstruction
  • locally advanced unilateral breast cancer
  • bilateral mastectomy for prophylaxis
  • Breast Neoplasms

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283