GammaPod Registry and Quality of Life Nomogram
NCT03562273 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 160
Last updated 2026-02-20
Summary
This study is a prospective, single arm study (registry) summarizing patient-level adverse-event and tumor outcomes as well as a number of feasibility and dosimetric characteristics of delivering a single-fraction boost with the GammaPod.
Conditions
- Breast Cancer Female
Interventions
- RADIATION
-
Quality Of Life Sizing Nomogram
If the participant meets the eligibility criteria of the study, and participant chooses to take part, they will receive the tumor bed boost in 8 Gy in 1 fraction just prior to starting whole breast radiation after joining the study. Treatment to the whole breast will begin within 7-8 days from the TB boost (GammaPodTM) treatment. The radiation therapy will take approximately 6 weeks to complete. Follow-up visits specifically for this study will continue for one year, although the physician will continue to follow as part of routine care.
Sponsors & Collaborators
-
University of Texas, Southwestern Medical Center at Dallas
collaborator OTHER -
University of Maryland, Baltimore
lead OTHER
Principal Investigators
-
Elizabeth M. Nichols, M.D. · University of Maryland
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-03
- Primary Completion
- 2028-12-31
- Completion
- 2030-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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