Clinical trial · Interventional
Effect of Radiation on Tissue for Delayed Breast Reconstruction
NCT01666899CI-TRIAL-00027850completedN/AClinicalTrials.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 purpose of this study is to investigate the effects of radiation therapy following mastectomy on skin and blood vessels and to use information gathered to determine an ideal time for breast reconstruction after radiation.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Skin and blood vessel procedures | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Skin and blood vessel procedures
- description
- All patients will be placed into Arm 1. They will undergo punch biopsies of the breast skin at the time of mastectomy and at 2, 4, 6, 8 and 12 months after completion of radiation therapy. Three more biopsies will be taken at 3, 6, and 12 months after completion of reconstruction. Patients will also undergo skin blood flow studies with a laser imaging device prior to each biopsy procedure. Ultrasound studies of the chest vessels will be performed 4 times over the course of the study- once prior to radiation and at 2, 6 and 12 months after radiation.
- interventionNames
- Procedure: Skin and blood vessel procedures
Primary outcomes (1)
- measure
- To evaluate cellular and histologic changes in mastectomy skin over time following completion of radiation therapy.
- timeFrame
- 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with invasive breast cancer who will require mastectomy and postmastectomy radiation therapy. 2. Patients who meet criteria 1, who plan on postmastectomy breast reconstruction Exclusion Criteria: 1. Male patients 2. Patients under the age of 18 3. Patients of advanced age (greater than 75) 4. Patients with comorbidities that affect wound healing.
References
Publications (0)
Data not yet available
No reference posted for this study.