Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Screening, Supportive care | Active | 18 to 90 | Other | UPCC 12110 NCT01292772 |
Summary
The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant radiation therapy on reconstructed breasts.
Further Study Information
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
Trial Lead Organizations/Sponsors
Abramson Cancer Center of the University of Pennsylvania
| Liza Wu, MD |  | Ph: (215)-662-2812 |
| Email: admin@ctsrmc.org | ||
Trial Sites
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| U.S.A. | |||
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| Pennsylvania | |||
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| Philadelphia | |||
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| Abramson Cancer Center of the University of Pennsylvania | |||
| Liza Wu, MD | Ph: 215-662-2812 | ||
| Email: admin@ctsrmc.org | |||
| Liza Wu, MD | Principal Investigator | ||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01292772
Information obtained from ClinicalTrials.gov on May 20, 2012
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