The Effects of Radiation in Reconstructed Breasts

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
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

February 1, 2011
February 25, 2013
December 2010
December 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01292772 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Effects of Radiation in Reconstructed Breasts
The Effects of Radiation Therapy on the Reconstructed Breast: An Evaluation Using MR Imaging

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

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

Breast Cancer
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 90 Years
No
Contact: Liza Wu, MD 855-216-0098 PennCancerTrials@emergingmed.com
United States
 
NCT01292772
UPCC 12110
Yes
Liza Wu, Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Not Provided
Abramson Cancer Center of the University of Pennsylvania
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP