The Effects of Radiation in Reconstructed Breasts

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292772
• Other study ID #: UPCC 12110
• Status: Completed
• Start date: December 2010
• Est. completion date: May 5, 2019

Study information

• Verified date: April 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 5, 2019
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reconstructed Breast Volume	This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.	up to 1 year after radiation
Primary	Vascular Fibrosis	This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.	up to 1 year after radiation
Primary	Dermal Thickness	This will be compared at 2 pionts: before radiation and 1 year after radiation is completed between the 2 breasts	up to 1 year after radiation
Secondary	Presence of Fat Necrosis in the Breast	This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.	up to 1 year after radiation
Secondary	Evidence of Cancer Recurrence	This will assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.	up to 1 year after radiation
Secondary	Symmetry	This will be assessed at 2 points; before radiation and 1 year after radiation is completed between the 2 breasts.	up to 1 year after radiation
Secondary	Hyperpigmentation	This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.	up to 1 year after radiation
Secondary	Contracture	This will be assessed at 2 points:before radiation and 1 year after radiation is completed between the 2 breasts.	up to 1 year after radiation
Secondary	Aesthetic Result	This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.	up to 1 year after radiation