Actively Recruiting
GammaPod Registry and Quality of Life Nomogram
Led by University of Maryland, Baltimore · Updated on 2026-02-20
160
Participants Needed
4
Research Sites
621 weeks
Total Duration
On this page
Sponsors
U
University of Maryland, Baltimore
Lead Sponsor
U
University of Texas, Southwestern Medical Center at Dallas
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
GammaPod Registry and Quality of Life Nomogram
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with invasive or non-invasive breast cancer treated by partial mastectomy
- Candidates for breast conserving therapy (not pregnant, no prior radiation to treated breast, suitable breast size for cosmesis)
- Patients with involved lymph nodes
- Negative surgical margins (no tumor on ink for invasive cancer, 2 mm margin for non-invasive cancer)
- Tumor size less than 4 cm before surgery
- Multifocal disease allowed if removed by single lumpectomy and breast conservation maintained
- Age 18 years or older
- Women of childbearing potential must have negative pregnancy test or complete pregnancy waiver
- Surgical cavity clearly visible on CT images (clips recommended but not required)
- Weight less than 150 kg (330 lb)
- Height less than 6 feet 6 inches
- Comfortable lying prone
- Prior contralateral breast cancer allowed
- Synchronous bilateral cancers allowed (bilateral boosts not on same day)
- Oncoplastic reduction surgery allowed if cavity visible
You will not qualify if you...
- Multi-centric carcinoma (tumors in different quadrants or separated by at least 4 cm)
- Prior radiation therapy to the treated breast or hemi thorax
- Unable to fit into immobilization breast cup with adequate seal
- Male gender
- Unable to comfortably lie prone (physical disability)
- Unable to fit breast immobilization device due to size or anatomy
- Mastectomy performed as surgery
- Tumor bed less than 3 mm from skin surface
- More than 50% of target volume above upper border of treatment table
- Skin involvement by tumor
- Connective tissue disorders (systemic lupus erythematosus, scleroderma, dermatomyositis)
- Psychiatric or addictive disorders preventing informed consent
- Pregnant or lactating women
- Presence of breast implants, tissue expanders, or flap reconstruction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Upper Chesapeake Health
Bel Air, Maryland, United States, 21014
Actively Recruiting
2
Central Maryland Oncology Center
Columbia, Maryland, United States, 21044
Actively Recruiting
3
Baltimore Washington Medical Center
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
4
UTSouthwestern
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
E
Elizabeth M. Nichols, M.D.
CONTACT
M
Madiha Qutab, M.S.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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