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The Effects of Radiation in Reconstructed Breasts

This study is currently recruiting participants.
Verified September 2016 by Abramson Cancer Center of the University of Pennsylvania
Sponsor:
ClinicalTrials.gov Identifier:
NCT01292772
First Posted: February 10, 2011
Last Update Posted: September 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
  Purpose
The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant radiation therapy on reconstructed breasts.

Condition Intervention
Breast Cancer Procedure: contract-enhanced MRI Radiation: Unilateral Adjuvant Radiation Therapy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Effects of Radiation Therapy on the Reconstructed Breast: An Evaluation Using MR Imaging

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: December 2010
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.
  Eligibility

Information from the National Library of Medicine

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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
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Liza Wu, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
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         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
  More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01292772     History of Changes
Other Study ID Numbers: UPCC 12110
First Submitted: February 1, 2011
First Posted: February 10, 2011
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