Clinical trial · Observational
The Effects of Radiation in Reconstructed Breasts
The Effects of Radiation Therapy on the Reconstructed Breast: An Evaluation Using MR Imaging
NCT01292772CI-TRIAL-00044538completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant radiation therapy on reconstructed breasts.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| contract-enhanced MRI | Procedure | — | UNRESOLVED |
| Unilateral Adjuvant Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Reconstructed Breast Volume
- timeFrame
- up to 1 year after radiation
- description
- This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
- measure
- Vascular Fibrosis
- timeFrame
- up to 1 year after radiation
- description
- This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
- measure
- Dermal Thickness
- timeFrame
- up to 1 year after radiation
- description
- This will be compared at 2 pionts: before radiation and 1 year after radiation is completed between the 2 breasts
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.