Actively Recruiting
GammaPod Dose Escalation Radiation for Early Stage Breast Cancer
Led by University of Maryland, Baltimore · Updated on 2026-02-20
50
Participants Needed
4
Research Sites
480 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The GammaPod machine was made by Xcision Medical Systems and is already FDA cleared to deliver focused radiation within the breast. Unlike current radiation machines, the GammaPod was designed specifically for treating breast cancer. The GammaPod can pinpoint radiation to the tumor bed in the breast which lowers the amount of radiation to nearby tissues. The machine uses a breast cup system to hold the breast in place for the treatment. This breast cup system was tested at MSGCCC (Marlene Stewart Greenebaum Comprehensive Cancer Center). Patients reported this system was more comfortable than an MRI or mammogram. The cup system was able to securely position the breast for treatment in the correct location. Receiving radiation before surgery is not a new concept in cancer management. Preoperative radiation has proven to result in improved disease free survival in certain types of cancer. With this study treatment, the participants will receive a dose of breast radiation therapy before the lumpectomy surgery. The lumpectomy surgery is where they remove the participant's tumor. The purpose of this research study is to determine a safe and effective dose of pre-operative radiation to treat early stage breast cancer. The pre-operative radiation is delivered using the FDA approved, GammaPod machine. The study will also determine the cosmesis of pre-operative radiation at different doses. Cosmesis is another word for looking at skin changes. The research team will use questionnaires for patient and physicians to assess adverse cosmesis changes as accurately as possible. In addition, the investigators are going to assess radiation related changes using photo software analysis tools and patients quality of life.
CONDITIONS
Official Title
GammaPod Dose Escalation Radiation for Early Stage Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must sign consent for study participation.
- Female patients with invasive ductal carcinoma diagnosis.
- Suitable candidates for breast-conserving therapy.
- Tumor does not involve overlying skin or underlying chest wall.
- Tumor size less than 3 cm based on ultrasound.
- Tumor must be unifocal.
- Patients older than 45 years.
- Tumor visible on CT scan.
- Patients must undergo MRI for tumor assessment and rule out additional disease.
- Clinically and radiographically node-negative (N0).
- Estrogen receptor positive tumors.
- HER2neu negative tumors.
- Weight less than 150 kg (330 lb).
- Height less than 6 feet 6 inches.
- Able to lie prone for treatment.
- No lymphovascular invasion on biopsy.
- Hormonal therapy allowed prior to treatment initiation.
You will not qualify if you...
- Multicentric disease.
- Prior radiation therapy to the involved breast.
- Unable to fit or seal immobilization breast cup.
- Male sex.
- Breast implants.
- Unable to lie prone comfortably due to physical disability.
- Planned mastectomy surgery.
- Tumor less than 5 mm from skin or chest wall.
- Tumor size greater than 3 cm.
- Psychiatric or addictive disorders preventing consent or completion.
- Pregnant or lactating women.
- Unable to undergo MRI.
- Lymphovascular invasion on biopsy.
- Tumors other than invasive ductal carcinoma.
- Estrogen receptor-negative tumors.
- HER2neu-positive tumors.
- Pure ductal carcinoma in situ.
- Weight over 330 lb.
- Prior cancer in the same breast.
- Diffuse calcifications on mammogram (BIRADS 3,4,5).
AI-Screening
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Trial Site Locations
Total: 4 locations
1
UMMC
Baltimore, Maryland, United States, 21201
Actively Recruiting
2
Upper Chesapeake Health
Bel Air, Maryland, United States, 21014
Actively Recruiting
3
Central Maryland Oncology Center
Columbia, Maryland, United States, 21044
Actively Recruiting
4
Baltimore Washington Medical Center
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
Research Team
E
Elizabeth Nichols, MD
CONTACT
C
Caitlin Eggleston
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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