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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 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.

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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.

Interventions

  • DRUG [18F]FMISO-PET with contrast-enhanced MRI

Study Locations (1)

Alabama

  • UAB - Birmingham

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2026-06
Est. Completion 2028-08
Phase Early Phase 1

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT04861077

The ClinicalTrials.gov registry entry for NCT04861077 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (92% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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