Clinical trial NCT01292772: The Effects of Radiation in Reconstructed Breasts
Official title: The Effects of Radiation Therapy on the Reconstructed Breast: An Evaluation Using MR Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
bilateral mastectomy
immediate breast reconstruction
locally advanced unilateral breast cancer
bilateral mastectomy for prophylaxis
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2011-02-10
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reconstructed Breast Volume
timeFrame: up to 1 year after radiation
measure: Vascular Fibrosis
timeFrame: up to 1 year after radiation
measure: Dermal Thickness
timeFrame: up to 1 year after radiation
Secondary outcomes:
measure: Presence of Fat Necrosis in the Breast
timeFrame: up to 1 year after radiation
measure: Evidence of Cancer Recurrence
timeFrame: up to 1 year after radiation
measure: Symmetry
timeFrame: up to 1 year after radiation
measure: Hyperpigmentation
timeFrame: up to 1 year after radiation
measure: Contracture
timeFrame: up to 1 year after radiation
measure: Aesthetic Result
timeFrame: up to 1 year after radiation
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
References: