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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01292772 |
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Date of registration:
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01/02/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effects of Radiation in Reconstructed Breasts
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Scientific title:
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The Effects of Radiation Therapy on the Reconstructed Breast: An Evaluation Using MR Imaging |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01292772 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Procedure: contract-enhanced MRI
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Radiation: Unilateral Adjuvant Radiation Therapy
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Primary Outcome(s)
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Vascular Fibrosis
[Time Frame: up to 1 year after radiation]
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Reconstructed Breast Volume
[Time Frame: up to 1 year after radiation]
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Dermal Thickness
[Time Frame: up to 1 year after radiation]
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Secondary Outcome(s)
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Presence of Fat Necrosis in the Breast
[Time Frame: up to 1 year after radiation]
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Aesthetic Result
[Time Frame: up to 1 year after radiation]
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Symmetry
[Time Frame: up to 1 year after radiation]
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Contracture
[Time Frame: up to 1 year after radiation]
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Evidence of Cancer Recurrence
[Time Frame: up to 1 year after radiation]
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Hyperpigmentation
[Time Frame: up to 1 year after radiation]
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Secondary ID(s)
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UPCC 12110
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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