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NCT05912231 · ClinicalTrials.gov registry record · NA
Ultrahypofractionation and Normal Tissue Toxicity
A NA study of Breast Cancer and Breast Cancer Female, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05912231: Active NA study of Breast Cancer and Breast Cancer Female, sponsored by Massachusetts General Hospital.
NCT05912231 is a NA study of Breast Cancer and Breast Cancer Female that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 60 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05912231, a NA study of Breast Cancer and Breast Cancer Female, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This research is being done to see if proton beam radiation therapy (PBT) results in fewer changes to a participant's heart measured with MRI-imaging than conventional or "photon" radiation therapy (XRT) for participants with non-metastatic left sided breast cancer. The names of the two study groups in this research study are: * Proton Radiation Therapy (PBT) * Conventional or "Photon" Radiation Therapy (XRT)
Primary Outcome
The primary outcome is to determine whether participants who receive accelerated PBT show no increase in myocardial fibrosis on Cardiac MRI (CMR) compared to an estimated 4% increase in extracellular matrix volume fraction (ECV) in participants who receive accelerated XRT. CMR will be performed using a 3T system (Skyra, Siemens). The T1 phase on MRI will be used to measure ECV.
Conditions Studied
Interventions
- RADIATION Accelerated Proton Beam Radiation Therapy (PBT)
- RADIATION Accelerated Photon Radiation Therapy (XRT)
Study Locations (1)
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-08-15 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What the registry record for NCT05912231 still lists
NCT05912231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 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 5 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Accelerated Proton Beam Radiation Therapy (PBT) is the first listed.
NCT05912231 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05912231 about?
NCT05912231 is a clinical study titled "Ultrahypofractionation and Normal Tissue Toxicity". This research is being done to see if proton beam radiation therapy (PBT) results in fewer changes to a participant's heart measured with MRI-imaging than conventional or "photon" radiation therapy (XRT) for participants with non-metastatic left sided breast cancer. The names of the two study group...
What is the current status of trial NCT05912231?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2023-08-15. Estimated completion is 2026-12-31.
What conditions does trial NCT05912231 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Cancer Female, Breast Cancer Stage II, Breast Cancer Stage III, Myocardial Fibrosis.
What interventions are being tested in trial NCT05912231?
The interventions under investigation include: Accelerated Proton Beam Radiation Therapy (PBT) (RADIATION), Accelerated Photon Radiation Therapy (XRT) (RADIATION).
Who is sponsoring clinical trial NCT05912231?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05912231 being conducted?
This trial has 1 study location across Massachusetts. 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 NCT05912231's enrollment target sits among peer trials
60 736th of 1224 higher than 468 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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