The Effects of Radiation in Reconstructed Breasts
This study is currently recruiting participants.
Verified February 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
Abramson Cancer Center of the University of Pennsylvania
Information provided by:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01292772
First received: February 1, 2011
Last updated: February 25, 2013
Last verified: February 2013
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Purpose
The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant radiation therapy on reconstructed breasts.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Procedure: contract-enhanced MRI Radiation: Unilateral Adjuvant Radiation Therapy |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | The Effects of Radiation Therapy on the Reconstructed Breast: An Evaluation Using MR Imaging |
Resource links provided by NLM:
Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:
Primary Outcome Measures:
- Reconstructed Breast Volume [ Time Frame: up to 1 year after radiation ] [ Designated as safety issue: No ]This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
- Vascular Fibrosis [ Time Frame: up to 1 year after radiation ] [ Designated as safety issue: No ]This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
- Dermal Thickness [ Time Frame: up to 1 year after radiation ] [ Designated as safety issue: No ]This will be compared at 2 pionts: before radiation and 1 year after radiation is completed between the 2 breasts
Secondary Outcome Measures:
- Presence of Fat Necrosis in the Breast [ Time Frame: up to 1 year after radiation ] [ Designated as safety issue: No ]This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
- Evidence of Cancer Recurrence [ Time Frame: up to 1 year after radiation ] [ Designated as safety issue: No ]This will assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
- Symmetry [ Time Frame: up to 1 year after radiation ] [ Designated as safety issue: No ]This will be assessed at 2 points; before radiation and 1 year after radiation is completed between the 2 breasts.
- Hyperpigmentation [ Time Frame: up to 1 year after radiation ] [ Designated as safety issue: No ]This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
- Contracture [ Time Frame: up to 1 year after radiation ] [ Designated as safety issue: No ]This will be assessed at 2 points:before radiation and 1 year after radiation is completed between the 2 breasts.
- Aesthetic Result [ Time Frame: up to 1 year after radiation ] [ Designated as safety issue: No ]This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Procedure: contract-enhanced MRI
Patients will have contrast-enhanced MRI of the breasts.
Radiation: 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.
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| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| 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.
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292772
Contacts
| Contact: Liza Wu, MD | 855-216-0098 | PennCancerTrials@emergingmed.com |
Locations
| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Liza Wu, MD 855-216-0098 PennCancerTrials@emergingmed.com | |
| Principal Investigator: Liza Wu, MD | |
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
More Information
No publications provided
| Responsible Party: | Liza Wu, Abramson Cancer Center of the University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01292772 History of Changes |
| Other Study ID Numbers: | UPCC 12110 |
| Study First Received: | February 1, 2011 |
| Last Updated: | February 25, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
|
breast cancer bilateral mastectomy immediate breast reconstruction locally advanced unilateral breast cancer bilateral mastectomy for prophylaxis |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013