Single FrAction Interstitial BreaSt BracHytherApy
Part of paid clinical trials in Richmond, Virginia.
- Sponsor
- Virginia Commonwealth University
- Study ID
- NCT07654257
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- FEMALE
- Age
- 40 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Partial Breast Irradiation — DRUG16 Gy × 1 fraction via multicatheter brachytherapy delivered over 1 day
Study Details
This phase 2, single arm prospective study has been designed to determine the safety of delivering accelerated partial breast irradiation (APBI) with a multicatheter interstitial implant in a single fraction over 1 day. This is a method of delivering radiation therapy directly into or close to a tumor.
Key Dates
- Start date
- Sep 1, 2026
- Status verified
- Jun 2026
- Primary completion
- Sep 30, 2036
- Completion
- Sep 30, 2036
Study Design
- Enrollment
- 134 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Partial Breast IrradiationBrachytherapy delivered with multiple interstitial catheters, given in a single fraction over 1 day
Primary Outcome Measure
Assess and compare the toxicity of a 1-day course of accelerated partial breast irradiation (APBI) to that of clinical trials: NSABP-B-39 (NCT00103181), RTOG-0413, TRIUMPH-T (NCT02526498), and ASHBY (NCT06185205) [ Time Frame: Baseline through 30 days following treatment, up to 5 years. ]
Central Contacts
- Massey IIT Research Operations804-628-6430
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | Bridget Quinn, MD (PRINCIPAL_INVESTIGATOR) |
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