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

Trial Summary

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 data supports the effectiveness of the treatment GammaPod Radiation for early stage breast cancer?

The GammaPod is a specialized device designed to deliver precise radiation to small breast cancers, using 25 rotating cobalt-60 sources to target the tumor accurately. Studies have shown that it can provide highly conformal (precisely shaped) radiation doses, which is important for effectively treating cancer while minimizing damage to surrounding healthy tissue. ^{1 2 3 4 5}

Is GammaPod Radiation safe for humans?

The GammaPod device has undergone detailed safety testing, including checks on radiation safety, mechanical systems, and safety interlocks, all of which performed correctly and met regulatory limits, indicating it is generally safe for use in humans. ^{1 2 3 4 6}

How is GammaPod Radiation treatment different from other breast cancer treatments?

GammaPod Radiation is unique because it uses a specialized device with 25 rotating cobalt-60 sources to deliver precise, high-dose radiation directly to early-stage breast cancer tumors. This treatment is highly targeted, minimizing exposure to surrounding healthy tissue, and can be administered in fewer sessions compared to traditional radiation therapy. ^{1 2 3 4 5}

What is the purpose of this trial?

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. The GammaPod can pinpoint radiation to the tumor bed in the breast which lowers the amount of radiation to nearby tissues. The machine uses a breast cup system to hold the breast in place for the treatment. This breast cup system was tested at MSGCCC (Marlene Stewart Greenebaum Comprehensive Cancer Center). Patients reported this system was more comfortable than an MRI or mammogram. The cup system was able to securely position the breast for treatment in the correct location. Receiving radiation before surgery is not a new concept in cancer management. Preoperative radiation has proven to result in improved disease free survival in certain types of cancer. With this study treatment, the participants will receive a dose of breast radiation therapy before the lumpectomy surgery. The lumpectomy surgery is where they remove the participant's tumor. The purpose of this research study is to determine a safe and effective dose of pre-operative radiation to treat early stage breast cancer. The pre-operative radiation is delivered using the FDA approved, GammaPod machine. The study will also determine the cosmesis of pre-operative radiation at different doses. Cosmesis is another word for looking at skin changes. The research team will use questionnaires for patient and physicians to assess adverse cosmesis changes as accurately as possible. In addition, the investigators are going to assess radiation related changes using photo software analysis tools and patients quality of life.

Research Team

Elizabeth Nichols, MD

Principal Investigator

University of Maryland, Baltimore

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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™ 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

SU-E-T-399: Dosimetric and Geometric Evaluation of a Novel Stereotactic Radiotherapy Device for Breast Cancer: The GammaPod. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A How-To Compendium for GammaPod Treatments, Clinical Workflow, and Clinical Program at an Early Adopting Institution. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Correlation of treatment time to target volume for GammaPod treatments: A simple second calculation. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Dosimetric and geometric evaluation of a novel stereotactic radiotherapy device for breast cancer: the GammaPod™. [2018]

5. United States 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Commissioning and acceptance guide for the GammaPod. [2020]