GammaPod Radiation for Early Stage Breast Cancer

Recruiting at 3 trial locations

Overseen By Elizabeth Nichols, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must be taking: Hormonal therapy

Disqualifiers: Multicentric disease, Breast implants, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation therapy for early-stage breast cancer using a machine called the GammaPod. The goal is to determine the safe amount of radiation that can be administered before surgery to remove the tumor. Researchers aim to assess whether this approach can improve skin appearance and overall quality of life after treatment. Women with a single, small breast tumor (less than 3 cm) that hasn't spread and who are estrogen-receptor positive may be suitable candidates for this trial. As an unphased study, this trial provides a unique opportunity to explore innovative treatment options that could enhance post-treatment outcomes.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients may continue taking hormonal therapy before starting the treatment.

What prior data suggests that the GammaPod machine is safe for treating early stage breast cancer?

Research has shown that GammaPod radiation therapy is generally easy for patients with early-stage breast cancer to handle. In studies, participants who received this treatment reported fewer side effects compared to those who underwent standard radiation therapy. The GammaPod targets radiation precisely at the tumor, protecting nearby healthy tissues.

Previous trials demonstrated that a single dose of this targeted radiation led to promising early cancer control and was well-tolerated. The FDA has approved this treatment, indicating it has met safety standards for treating breast cancer.

Patients have found the breast cup system used during treatment more comfortable than an MRI or mammogram. This system keeps the breast steady and in the correct position during radiation. Overall, GammaPod radiation therapy has maintained a good safety record, with patients experiencing fewer side effects than with traditional methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about GammaPod radiation for early-stage breast cancer because it offers a precise, targeted approach that minimizes damage to surrounding healthy tissue. Unlike traditional whole-breast radiation therapy, GammaPod focuses on delivering radiation directly to the tumor area, which could potentially reduce side effects and shorten treatment times. This technology allows for varying doses, such as 21 Gy, 24 Gy, 27 Gy, and 30 Gy, to find the optimal balance between effectiveness and safety. By concentrating the radiation only where it's needed, GammaPod aims to improve patient outcomes and quality of life.

What evidence suggests that the GammaPod Radiation is effective for early stage breast cancer?

Research has shown that the GammaPod machine can effectively target radiation directly at breast tumors. This technology focuses radiation precisely on the tumor, protecting nearby healthy tissue. In this trial, participants will receive varying dose levels of GammaPod radiation before breast cancer surgery. Studies have found that the GammaPod may cause fewer side effects than standard treatments. Additionally, it can deliver a single, strong dose of radiation to the tumor without increasing expected side effects. This targeted approach may improve treatment outcomes by accurately targeting the cancer while sparing healthy breast tissue. ^{1 2 3 4 6}

Who Is on the Research Team?

Elizabeth Nichols, MD

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This trial is for women over 45 with early-stage invasive ductal breast cancer, visible on a CT scan, node-negative, estrogen-receptor positive, HER2neu negative, and tumors under 3 cm. Candidates must be able to lie prone and fit within the GammaPod machine's size limits (under 330 lb in weight and less than 6'6" tall).

Inclusion Criteria

Your biopsy results show no invasion of lymphatic vessels or blood vessels.

My cancer is located in just one area.

Patients must sign consent for study participation

Exclusion Criteria

My cancer is not invasive ductal carcinoma.

My tumor is HER2 positive.

You have breast implants.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive a single-fraction preoperative radiation therapy using the GammaPod technology before lumpectomy

1 day

1 visit (in-person)

Surgery

Participants undergo lumpectomy surgery to remove the tumor

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and cosmesis changes after treatment

5 years

Regular visits (in-person and virtual) over 5 years

What Are the Treatments Tested in This Trial?

Interventions

• GammaPod Radiation

Trial Overview The study tests pre-operative radiation doses using the GammaPod system before lumpectomy surgery in breast cancer patients. It aims to find a safe dose that effectively treats the cancer while assessing skin changes and quality of life through questionnaires and photo software analysis.

How Is the Trial Designed?

Group I: Dose Level 1: 21 Gy Active Control 1 Intervention

Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.

Group II: Dose Level 3: 27 Gy Active Control 1 Intervention

Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.

Group III: Dose Level 2: 24 Gy Active Control 1 Intervention

Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.

Group IV: Dose Level 4: 30 Gy Active Control 1 Intervention

Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.

GammaPod Radiation is already approved in United States, European Union for the following indications:

Approved in United States as GammaPod for:

• Early stage breast cancer

Approved in European Union as GammaPod for:

• Early stage breast cancer

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

The GammaPodTM device, designed for stereotactic radiotherapy in early-stage breast cancer, demonstrated excellent dosimetric accuracy with a spatial precision of less than 1 mm and a high Gamma index pass rate of over 97% in dosimetric verifications for eight patients.

With a delivery rate of 5.31 Gy/min and the ability to create complex treatment plans through dynamic dose shaping, the GammaPod provides uniform doses to targets, indicating its potential efficacy in improving treatment outcomes for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SU-E-T-399: Dosimetric and Geometric Evaluation of a Novel Stereotactic Radiotherapy Device for Breast Cancer: The GammaPod. Mutaf, Y., Yu, C., Zhang, J., et al.[2019]

The GammaPod™ device, designed specifically for treating small breast cancers, demonstrated high dosimetric accuracy and spatial precision, with an isocenter location accuracy of less than 1 mm and a gamma index pass rate of over 97% in dosimetric verifications for seven patients.

This innovative stereotactic radiotherapy system delivers uniform doses with a rate of 5.31 Gy/min, utilizing dynamic dose shaping and noncoplanar beam arrangements, making it a promising option for complex breast cancer treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric and geometric evaluation of a novel stereotactic radiotherapy device for breast cancer: the GammaPod™. Mutaf, YD., Zhang, J., Yu, CX., et al.[2018]

The study developed a reliable method to estimate treatment times for the GammaPod device used in breast cancer therapy, based on target volume, using data from 59 patient treatments.

The method demonstrated high accuracy in predicting treatment times for an additional 30 patients, with an average difference of only 1.0 minute from actual times, making it a useful tool for quality assurance in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation of treatment time to target volume for GammaPod treatments: A simple second calculation. Chen, L., Becker, SJ., McAvoy, SA., et al.[2022]

The GammaPod breast treatment device effectively delivers stereotactic radiation therapy while patients are in a prone position, utilizing 25 non-overlapping Co-60 beams for precise targeting of breast tissue.

Comprehensive testing of the GammaPod's subsystems, including mechanical, dosimetric, and safety features, confirmed its reliability and compliance with safety regulations, ensuring accurate and safe treatment delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commissioning and acceptance guide for the GammaPod. Becker, S., Sabouri, P., Niu, Y., et al.[2020]

GammaPod is a specialized device for stereotactic radiation therapy of breast cancer, which has been effectively used at our institution for various treatment protocols, including adjuvant partial breast irradiation and preoperative radiation.

In our experience with 93 patients treated from 2019 to 2021, we developed techniques to improve workflow efficiency, highlighting the practical application and potential benefits of GammaPod in breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A How-To Compendium for GammaPod Treatments, Clinical Workflow, and Clinical Program at an Early Adopting Institution. Zhang-Velten, E., Zhang, Y., Radpour, S., et al.[2022]

The GammaPod, a specialized machine for breast stereotactic radiosurgery, has been validated with a patient-specific quality assurance (PSQA) system that ensures accurate dose delivery, showing agreement within 2.7% of the treatment planning system.

The PSQA methods, including both measurement and calculation approaches, demonstrated high precision with a gamma pass rate of 97.0% for relative dose distributions, confirming the GammaPod's efficacy in delivering targeted radiation therapy safely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of a comprehensive patient-specific quality assurance program for a novel stereotactic radiation delivery system for breast lesions. Becker, SJ., Niu, Y., Mutaf, Y., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11110030/

A Prospective Trial of Single-Fraction Radiation to the ... The GammaPod device successfully delivered a single-fraction boost treatment to the tumor bed with no change in expected acute toxicities.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3637326/

GammaPod—A new device dedicated for stereotactic ... It is envisioned that the GammaPod technology has the potential to significantly shorten radiation treatments and even eliminate surgery by ablating the tumor ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2020-07926

Single Dose Preoperative Breast Stereotactic Body ... A single dose of preoperative breast stereotactic body radiation therapy using the GammaPod machine may produce fewer side effects than standard treatment and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03581136

Study Details | NCT03581136 | Phase II Multi-center Trial ... As the GammaPod will allow us to minimize the volume of normal breast being irradiated, and decrease the PTV volume we hypothesize that a stereotactic technique ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0360301625064004?dgcid=rss_sd_all

Post-Operative Single Fraction Stereotactic Partial Breast ... GammaPod™ represents a dedicated stereotactic system specifically developed for breast radiotherapy. The clinical procedure for the GammaPod™ ...

6. umms.org umms.org/umgccc/news/2017/stereotactic-radiation-therapy-system-designed-to-treat-early-stage-breast-cancer

First Stereotactic Radiation Therapy System Designed To ... The GammaPod enables this technology to be used for breast cancer. The GammaPod system targets a tumor with thousands of precisely focused beams ...