The Effects of Radiation in Reconstructed Breasts

NCT01292772 | Completed DMC

• 1 other identifier: UPCC 12110
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

breast cancer; bilateral mastectomy; immediate breast reconstruction; locally advanced unilateral breast cancer; bilateral mastectomy for prophylaxis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Presence of Fat Necrosis in the Breast

  up to 1 year after radiation

• Evidence of Cancer Recurrence

  up to 1 year after radiation

• Symmetry

  up to 1 year after radiation

• Hyperpigmentation

  up to 1 year after radiation

• Contracture

  up to 1 year after radiation

Interventions

contract-enhanced MRI PROCEDURE

Patients will have contrast-enhanced MRI of the breasts.

Unilateral Adjuvant Radiation Therapy RADIATION

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 10, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: May 5, 2019
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

US (1)