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Radiation Therapy

GammaPod Radiation for Early Stage Breast Cancer

N/A
Recruiting
Led By Elizabeth Nichols, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tumor must be unifocal
Patients must be estrogen-receptor positive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing a new way to give radiation therapy to people with early stage breast cancer. The hope is that this will be a more effective and less harmful treatment than current methods.

Who is the study for?
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).Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include skin changes at the radiation site such as redness or irritation. Since this is an investigational study determining safety, other side effects will be monitored including any discomfort from lying prone during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is located in just one area.
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My cancer is estrogen-receptor positive.
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My cancer has not spread to my lymph nodes.
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I am a good candidate for surgery that aims to save most of my breast.
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I am currently on hormonal therapy.
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I am older than 45 years.
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I am a woman diagnosed with invasive ductal carcinoma.
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I have had an MRI to check my cancer and any new spots were tested and are not cancer.
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My tumor does not affect the skin or chest wall.
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My cancer is not HER2 positive.
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My largest tumor is smaller than 3 cm, as confirmed by ultrasound or MRI before biopsy.
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I can lie on my stomach for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Establish the single-fraction radiation dose (MTD)
Incidence of Dose-Limiting Toxicities (DLTs)
Secondary outcome measures
Establish a Comprehensive Safety Profile of single-fraction PBI delivered with the GammaPod
Rate of ipsilateral local tumor recurrence
Rate of pathologic complete response (pCR)

Trial Design

4Treatment groups
Active Control
Group I: Dose Level 1: 21 GyActive Control1 Intervention
Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.
Group II: Dose Level 3: 27 GyActive Control1 Intervention
Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.
Group III: Dose Level 2: 24 GyActive Control1 Intervention
Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.
Group IV: Dose Level 4: 30 GyActive Control1 Intervention
Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
685 Previous Clinical Trials
372,996 Total Patients Enrolled
11 Trials studying Breast Cancer
311 Patients Enrolled for Breast Cancer
Elizabeth Nichols, MDPrincipal InvestigatorUniversity of Maryland, Baltimore
3 Previous Clinical Trials
65 Total Patients Enrolled
3 Trials studying Breast Cancer
65 Patients Enrolled for Breast Cancer

Media Library

GammaPod Radiation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04234386 — N/A
Breast Cancer Research Study Groups: Dose Level 1: 21 Gy, Dose Level 3: 27 Gy, Dose Level 2: 24 Gy, Dose Level 4: 30 Gy
Breast Cancer Clinical Trial 2023: GammaPod Radiation Highlights & Side Effects. Trial Name: NCT04234386 — N/A
GammaPod Radiation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04234386 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sample size of this research endeavor?

"Affirmative, the information posted on clinicaltrials.gov affirms that this research project is actively seeking participants. The trial was originally posted on September 15th 2021 and has most recently been revised on November 8th 2021. This investigation requires 50 volunteers to be recruited from 4 different medical centres."

Answered by AI

To what extent has this trial been disseminated to medical institutions?

"Participants can choose from 4 distinct clinical sites, such as Upper Chesapeake Health in Bel Air and UMMC in Baltimore. Additionally, Central Maryland Oncology Center located in Columbia is available for enrollment. The other locations will be listed during the application process."

Answered by AI

Is there still availability to join this clinical exploration?

"Clinicaltrials.gov affirms that recruitment for this medical research is currently ongoing, with the experiment originally posted on September 15th 2021 and recently updated on November 8th 2021."

Answered by AI
~26 spots leftby Dec 2026