The Effects of Radiation in Reconstructed Breasts
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ClinicalTrials.gov Identifier: NCT01292772 |
Recruitment Status
:
Recruiting
First Posted
: February 10, 2011
Last Update Posted
: September 26, 2016
|
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Condition or disease | Intervention/treatment |
---|---|
Breast Cancer | Procedure: contract-enhanced MRI Radiation: Unilateral Adjuvant Radiation Therapy |
Study Type : | Observational |
Estimated Enrollment : | 20 participants |
Time Perspective: | Prospective |
Official Title: | The Effects of Radiation Therapy on the Reconstructed Breast: An Evaluation Using MR Imaging |
Study Start Date : | December 2010 |
Estimated Primary Completion Date : | December 2016 |

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Procedure: contract-enhanced MRI
- Reconstructed Breast Volume [ Time Frame: up to 1 year after radiation ]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 ]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 ]This will be compared at 2 pionts: before radiation and 1 year after radiation is completed between the 2 breasts
- Presence of Fat Necrosis in the Breast [ Time Frame: up to 1 year after radiation ]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 ]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 ]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 ]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 ]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 ]This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292772
Contact: Liza Wu, MD | 855-216-0098 | PennCancerTrials@emergingmed.com |
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 |
Responsible Party: | Abramson Cancer Center of the University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT01292772 History of Changes |
Other Study ID Numbers: |
UPCC 12110 |
First Posted: | February 10, 2011 Key Record Dates |
Last Update Posted: | September 26, 2016 |
Last Verified: | September 2016 |
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 |