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New treatment option for Breast Cancer
Official title GammaPod Dose Escalation Radiation for Early Stage Breast Cancer
ClinicalTrials.gov ID: NCT04234386
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older, women only
You may be able to join if
- 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...
- Patients must be deemed appropriate candidates for breast-conserving therapy (i.e., not pregnant, never had RT to the treated breast, breast size...
- 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...
You likely can't join if
- 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.
See the full eligibility criteria
- 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...
- 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Bel Air, Maryland, United States
- Columbia, Maryland, United States
- Glen Burnie, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Bel Air, Maryland, United States; Columbia, Maryland, United States; Glen Burnie, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.