NCT03562273 · University of Maryland, Baltimore
GammaPod Registry and Quality of Life Nomogram
(GCC 1876)
What this study is about
This study is a forward-looking, single treatment group$1 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- The patient must sign consent for study participation.
- The patient must be female and have a diagnosis of an invasive or non-invasive breast cancer that was treated surgically by a partial mastectomy.
- The patient must be deemed an appropriate candidate for breast conserving therapy (i.e. not pregnant, never had radiation to the treated breast, breast size would allow adequate cosmesis after volume loss from partial mastectomy).
- Patients with involved lymph nodes are candidates for the study.
- Surgical margins are negative for invasive (no tumor on ink) or non-invasive breast cancer (2 mm negative margin).
- The greatest dimension of the tumor is less than 4cm before surgery.
- Multifocal disease is allowed if it was removed by a single lumpectomy resection and the patient remained a candidate for breast conservation.
- Age 18 years and older.
- Women of childbearing potential (pre-menopausal defined as having a menstrual period within the past 1 year) must have a negative serum pregnancy test or complete a pregnancy waiver form per institutional policy.
- The surgical cavity is clearly visible on CT images. Of note, clips are not required but recommended.
- The patient must weigh less than 150Kg (330lb), which is the limit of the imaging couch.
- The patient must be less than 6'6" in height.
- The patient must feel comfortable in the prone position.
- Diagnosis of prior contralateral breast cancer is allowed.
- Diagnosis of synchronous bilateral cancers is allowed. In this case if bilateral boosts are required, a patient would not have both treatments on the same day.
- Oncoplastic reduction surgery is allowed if the lumpectomy cavity can be clearly visualized.
Exclusion criteria
- Patients with proven multi-centric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm).
- Prior radiation therapy to that breast or that hemi thorax.
- Unable to fit into the immobilization breast cup with an adequate seal.
- Male gender.
- Patient cannot comfortably be set up in the prone position (i.e. physical disability)
- Unable to fit into the breast immobilization device due to breast size or other anatomical reason.
- Mastectomy is the surgery performed.
- Patient has received prior radiotherapy to the involved breast.
- Tumor bed is less than 3 mm from the skin surface.
- Greater than 50% of the target volume is above the upper border of the table.
- Patients with skin involvement, regardless of tumor size.
- Patients with connective tissue disorders specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.
- Patients with psychiatric or addictive disorders that would preclude obtaining informed consent.
- Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females.
- Patients with breast implants/tissue expanders or flap reconstruction.
Where
- Bel Air, Maryland
- Columbia, Maryland
- Glen Burnie, Maryland
- Dallas, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 20, 2026 · Source of record for eligibility and locations