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Completed

NCT Number: NCT01292772

The Effects of Radiation in Reconstructed Breasts

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

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Key information

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2019
First posted
Feb 10, 2011
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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