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NCT04861077 · ClinicalTrials.gov registry record · Early Phase 1
Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)
A Early Phase 1 study of Triple Negative Breast Cancer, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04861077: Recruiting Early Phase 1 study of Triple Negative Breast Cancer, sponsored by University of Alabama at Birmingham.
NCT04861077 is a Early Phase 1 study of Triple Negative Breast Cancer that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 20 participants, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04861077, a Early Phase 1 study of Triple Negative Breast Cancer, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical study will investigate the utility of Fludeoxyglucose (18F) fluoromisonidazole (FMISO), in patients diagnosed with triple negative breast cancer (stage II-IV disease), to monitor and predict the effect of immunotherapy. This is a parallel imaging study to current treatment strategies and no clinical decisions or outcomes will be based on the imaging. If promising, this data will be used to design larger trials. A total of 20 patients will be recruited for this study. This trial will not designate the participant's treatment plan; they will be eligible based on their treatment plan designated from their oncologist.
Primary Outcome
Compare baseline metrics from PET/MRI
Conditions Studied
Interventions
- DRUG [18F]FMISO-PET with contrast-enhanced MRI
Study Locations (1)
Alabama
- UAB - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-06 |
| Est. Completion | 2028-08 |
| Phase | Early Phase 1 |
What NCT04861077 shows while recruiting
NCT04861077 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which [18F]FMISO-PET with contrast-enhanced MRI is the first listed.
NCT04861077 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT04861077 about?
NCT04861077 is a clinical study titled "Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)". This clinical study will investigate the utility of Fludeoxyglucose (18F) fluoromisonidazole (FMISO), in patients diagnosed with triple negative breast cancer (stage II-IV disease), to monitor and predict the effect of immunotherapy. This is a parallel imaging study to current treatment strategies a...
What is the current status of trial NCT04861077?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2026-06. Estimated completion is 2028-08.
What conditions does trial NCT04861077 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer.
What interventions are being tested in trial NCT04861077?
The interventions under investigation include: [18F]FMISO-PET with contrast-enhanced MRI (DRUG).
Who is sponsoring clinical trial NCT04861077?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04861077 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Triple Negative 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 NCT04861077's enrollment target sits among peer trials
20 103rd of 118 higher than 15 of 118 other Triple Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Triple Negative 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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