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GammaPod Radiation for Early Stage Breast Cancer

This study is testing a new way to deliver radiation called GammaPod Radiation for early-stage breast cancer. The GammaPod machine is designed specifically for breast cancer and aims to precisely target the tumor, reducing radiation to healthy tissues. You would receive GammaPod Radiation before lumpectomy surgery. The study is trying to find the highest safe dose of this radiation and track any side effects over five years. To join, you must be a woman at least 45 years old with invasive ductal carcinoma (a type of breast cancer) who is a candidate for breast-conserving surgery. The study plans to enroll 50 participants.

Study design
This is a dose-escalation study with 4 different dose levels of GammaPod Radiation. It plans to enroll 50 participants.
What's involved
You would receive a specific dose level of GammaPod Radiation before your lumpectomy surgery. The study will track your progress and any side effects for 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years to measure the radiation dose and any side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04234386

GammaPod Dose Escalation Radiation for Early Stage Breast Cancer

Recruiting
NAAges 45+InterventionalTreatment
University of Maryland, Baltimore
~50 participants
Updated 2026-02-20 on ClinicalTrials.gov
What's tested:GammaPod Radiation

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Establish the single-fraction radiation dose (MTD)
Measured over 5 years
+1 more outcome measured

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

4 sites across 1 states
Maryland4

Study leadership

  • Elizabeth Nichols, MD · PRINCIPAL_INVESTIGATOR · University of Maryland, Baltimore

Who to contact

Elizabeth Nichols, MD
[email protected]
410-328-6080
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients must sign consent for study participation.
Patients must be female with a diagnosis of invasive ductal carcinoma. Lobular histologies will not be included, because of difficulty in defining the extent of disease with imaging.
Patients must be deemed appropriate candidates for breast-conserving therapy (i.e., not pregnant, never had RT to the treated breast, breast size would allow adequate cosmesis after volume loss from partial mastectomy).
Tumor must not involve the overlying skin or underlying chest wall, based on imaging evaluation and/or clinical exam.
Greatest tumor dimension is \<3 cm based on US. MR imaging measurements can be included only if performed BEFORE the biopsy (postbiopsy measurements can be larger as a result of hematoma formation or increased edema).
Tumor must be unifocal.
Patients must be \> 45 years old.
The tumor must be visible on a CT scan.
Patients must undergo MR imaging for work-up to aid in tumor delineation and to rule out additional foci of disease. If additional foci of disease are found to be present, then these must be biopsied with negative results to proceed with treatment.
The tumor must be clinically and radiographically N0 (node negative). If a suspicious node is visualized, it must be biopsied with negative results.
Patients must be estrogen-receptor positive.
Patients must be HER2neu negative.
Patients must weigh \<150 kg (330 lb), which is the limit of the imaging loader.
Patients must be \<6'6" in height, again because of instrumentation limitations.
Patients must be able to lie prone for treatment.
Patients must have no lymphovascular invasion on biopsy.
Patients may be taking hormonal therapy prior to initiation of treatment. This will be documented.

Exclusion

Multicentric disease.
Prior RT to the involved breast.
Inability to fit into the immobilization breast cup because of breast size or other anatomic reasons.
Inability to obtain an adequate seal when using the immobilization breast cup.
Male sex.
Breast implants.
Patient cannot comfortably lie in the prone position (i.e., physical disability).
Patients who are planned to be treated surgically with a mastectomy.
Tumor \<5 mm from the skin surface or chest wall on clinical exam and/or radiographic imaging.
Tumor size \>3 cm.
Patients with psychiatric or addictive disorders that would preclude obtaining informed consent or study completion.
Patients who are pregnant or lactating (because of potential RT exposure to the fetus and unknown effects of RT in lactating women).
Patient unable to undergo MR imaging (e.g., because of known contrast reaction or concerns about contrast and existing health status).
Lymphovascular invasion on original biopsy.
Tumor histologies other than invasive ductal carcinoma (including invasive lobular carcinoma).
ER-negative tumors.
HER2neu-positive tumors.
Pure ductal carcinoma in situ (no invasive component).
Weight \>330 lb
Prior ipsilateral breast cancer.
Diffuse calcifications on mammogram (BIRADS 3, 4, 5).

What this trial measures

  • Establish the single-fraction radiation dose (MTD)5 years

    To establish the single-fraction radiation dose (MTD) delivered with the GammaPod that causes an incidence of dose-limiting toxicities (DLTs) that is statistically significantly 10% or lower.

  • Incidence of Dose-Limiting Toxicities (DLTs)5 years

    The primary endpoint is DLTs defined as one or more instances of: * Surgical infection: Defined as redness that resolves on antibiotics (sometimes the surgical site may look red as a result of natural healing processes and does not resolve with antibiotics) with or without fever and/or elevated white blood cell count. The risk of infection for this surgical procedure (lumpectomy ± SLN biopsy) is \<5%. * Nonhealing surgical incision (\>30 days). The risk is \<5%. * Reoperation secondary to infection/wound healing problem. Risk is \<5%.