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NCT04234386 · ClinicalTrials.gov registry record · NA
GammaPod Dose Escalation Radiation for Early Stage Breast Cancer
A NA study of Breast Cancer, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 4
- Study locations
NCT04234386: Recruiting NA study of Breast Cancer, sponsored by University of Maryland, Baltimore.
NCT04234386 is a NA study of Breast Cancer that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 50 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04234386, a NA study of Breast Cancer, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- RADIATION GammaPod Radiation
Study Locations (4)
Maryland
- UMMC - Baltimore
- Upper Chesapeake Health - Bel Air
- Central Maryland Oncology Center - Columbia
- Baltimore Washington Medical Center - Glen Burnie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-09-15 |
| Est. Completion | 2030-12 |
| Phase | NA |
What NCT04234386 shows while recruiting
NCT04234386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which GammaPod Radiation is the first listed.
NCT04234386 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04234386 about?
NCT04234386 is a clinical study titled "GammaPod Dose Escalation Radiation for Early Stage Breast Cancer". 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...
What is the current status of trial NCT04234386?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2021-09-15. Estimated completion is 2030-12.
What conditions does trial NCT04234386 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT04234386?
The interventions under investigation include: GammaPod Radiation (RADIATION).
Who is sponsoring clinical trial NCT04234386?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04234386 being conducted?
This trial has 4 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04234386's enrollment target sits among peer trials
50 789th of 1224 higher than 410 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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