New radiation device aims to cut breast cancer treatment time
NCT ID NCT03562273
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a special radiation device called the GammaPod to give a single, precise dose of radiation to the area where breast cancer was removed. The goal is to see if this approach can shorten the overall treatment time by a few days and improve patients' quality of life. About 160 women who have had breast-conserving surgery will participate. Researchers will track side effects, tumor control, and use questionnaires to measure quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2019
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Women with breast cancer
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baltimore Washington Medical Center
RECRUITINGGlen Burnie, Maryland, 21061, United States
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Central Maryland Oncology Center
RECRUITINGColumbia, Maryland, 21044, United States
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UTSouthwestern
RECRUITINGDallas, Texas, 75390, United States
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Upper Chesapeake Health
RECRUITINGBel Air, Maryland, 21014, United States
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Other studies related to the condition(s) this trial covers.
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