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NCT04332588 · ClinicalTrials.gov registry record · Phase 1

Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI

A Phase 1 study of HER2-positive Breast Cancer, sponsored by University of Alabama at Birmingham.

Recruiting
Registry status
Phase 1
Development phase
25
Enrollment target
1
Study location

NCT04332588: Recruiting Phase 1 study of HER2-positive Breast Cancer, sponsored by University of Alabama at Birmingham.

NCT04332588 is a Phase 1 study of HER2-positive Breast Cancer that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 25 participants, below the 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04332588, a Phase 1 study of HER2-positive Breast Cancer, is actively recruiting participants, sponsored by University of Alabama at Birmingham.

RECRUITING
Registry status
Phase 1
Development phase
25 participants
Enrollment target
1
Study location

Study Summary

The purpose of the study is to see if using an investigational drug called \[18F\]FMISO with PET/MRI imaging can help monitor and predict the effect of trastuzumab (Herceptin) on chemotherapy in patients diagnosed with advanced HER2 positive breast cancer. This study is for imaging purposes only and is not a treatment study. The results of this study will not change a patient's clinical treatment plan but it may help physicians and researchers better understand how best to treat patients with breast cancer in the future.

Primary Outcome

Compare baseline metrics from PET/MRI

Interventions

  • DRUG [18F]FMISO PET/MRI imaging

Study Locations (1)

Alabama

  • The University of Alabama at Birmingham - Birmingham

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2022-03-25
Est. Completion 2027-08
Phase Phase 1
University of Alabama at Birmingham

1,160 total trials

What NCT04332588 shows while recruiting

NCT04332588 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (89% lower).

The record links to 1 condition, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which [18F]FMISO PET/MRI imaging is the first listed.

NCT04332588 reports a single indexed study location in Alabama.

Frequently Asked Questions

What is clinical trial NCT04332588 about?

NCT04332588 is a clinical study titled "Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI". The purpose of the study is to see if using an investigational drug called \[18F\]FMISO with PET/MRI imaging can help monitor and predict the effect of trastuzumab (Herceptin) on chemotherapy in patients diagnosed with advanced HER2 positive breast cancer. This study is for imaging purposes only and...

What is the current status of trial NCT04332588?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2022-03-25. Estimated completion is 2027-08.

What conditions does trial NCT04332588 study?

This clinical trial studies the following conditions: HER2-positive Breast Cancer.

What interventions are being tested in trial NCT04332588?

The interventions under investigation include: [18F]FMISO PET/MRI imaging (DRUG).

Who is sponsoring clinical trial NCT04332588?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04332588 being conducted?

This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for HER2-positive 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 NCT04332588's enrollment target sits among peer trials

25 47th of 58 higher than 11 of 58 other HER2-positive Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HER2-positive 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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Source: ClinicalTrials.gov NCT04332588, the US trial registry maintained by the National Library of Medicine. NCT04332588 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.