Clinical Trials Directory

Trials / Completed

CompletedNCT01292772

The Effects of Radiation in Reconstructed Breasts

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

Status
Completed
Phase
Study type
Observational
Enrollment
12 (actual)
Sponsor
Abramson Cancer Center at Penn Medicine · Academic / Other
Sex
Female
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

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

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREcontract-enhanced MRIPatients will have contrast-enhanced MRI of the breasts.
RADIATIONUnilateral Adjuvant Radiation TherapyThe 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.

Timeline

Start date
2010-12-01
Primary completion
2016-12-01
Completion
2019-05-05
First posted
2011-02-10
Last updated
2020-04-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01292772. Inclusion in this directory is not an endorsement.