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Advanced PET/MRI Imaging for Breast Cancer

Phase 1
Recruiting
Led By Jonathan McConathy, MD, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Locally advanced stage II-III HER2+ breast cancer patients eligible for neoadjuvant therapy who are naïve to beginning treatment
Patients must be ≥ 18 years old and ≤ 75 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 5 years
Awards & highlights

Study Summary

This trial is testing whether using a new imaging technique can help predict how well a patient with advanced breast cancer will respond to chemotherapy.

Who is the study for?
This trial is for adults aged 18-75 with advanced HER2+ breast cancer, eligible for neoadjuvant therapy and not yet started treatment. Participants must have a tumor identifiable by imaging and an expected lifespan over one year. Pregnant or breastfeeding women, those with MRI contraindications like certain metal implants, tattoos, or weighing over 350 lbs., are excluded.Check my eligibility
What is being tested?
[18F]FMISO PET/MRI imaging is being tested to monitor the response of HER2+ breast cancer to trastuzumab (Herceptin) combined with chemotherapy. This study aims to improve future treatments but won't alter current patient care plans.See study design
What are the potential side effects?
Since this trial focuses on imaging rather than treatment, side effects may include reactions related to the PET/MRI procedure such as discomfort from lying still or potential allergic reactions to contrast agents used during the scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have stage II-III HER2+ breast cancer and haven't started treatment yet.
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I am between 18 and 75 years old.
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My breast cancer is HER2 positive based on lab tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Baseline measure of PET standardized uptake value (SUV).
Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.
Baseline measure of signal enhancement ratio (SER) from MRI.
+3 more
Secondary outcome measures
Changes in ADC (mm2/sec) from MRI.
Changes in SER from MRI.
Changes in SUV from PET.
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Herceptin monotherapy cohortExperimental Treatment1 Intervention
Herceptin monotherapy cohort. Locally advanced HER2+ breast cancer patients receiving neoadjuvant Herceptin monotherapy prior to combination therapy will undergo three contrast-enhanced [18F]FMISO PET/MRI scans. Each imaging session will be identical. Imaging session one will be after diagnosis and before beginning monotherapy. Imaging session two will be within 10 days prior to beginning combination therapy with targeted HER2 agents. Imaging session three will be within 10 days prior to beginning the second round of combination therapy with targeted HER2 agents.
Group II: Combination therapy cohortExperimental Treatment1 Intervention
Locally advanced HER2+ breast cancer patients that receiving neoadjuvant combination therapy including Herceptin will undergo two contrast-enhanced [18F]FMISO PET/MRI imaging. Imaging session one will be after diagnosis and before beginning combination therapy. Imaging session two will be within 10 days prior to beginning the second round of combination therapy with targeted HER2 agents.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,457 Total Patients Enrolled
32 Trials studying Breast Cancer
4,491 Patients Enrolled for Breast Cancer
Jonathan McConathy, MD, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
5 Previous Clinical Trials
169 Total Patients Enrolled
Janis O'Malley, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

[18F]FMISO PET/MRI imaging Clinical Trial Eligibility Overview. Trial Name: NCT04332588 — Phase 1
Breast Cancer Research Study Groups: Herceptin monotherapy cohort, Combination therapy cohort
Breast Cancer Clinical Trial 2023: [18F]FMISO PET/MRI imaging Highlights & Side Effects. Trial Name: NCT04332588 — Phase 1
[18F]FMISO PET/MRI imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT04332588 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the main purpose of this clinical exploration?

"The scope of this medical trial, which is slated to run for 6 months from Baseline measurements, will evaluate changes in ADC from MRI scans. Additional endpoints include SER comparisons between imaging visits and baseline results; clinical response assessments such as disease free-survival or recurrence; and percent change evaluation of SUV between imaging visit 2 and the initial measurement."

Answered by AI

How many candidates are participating in this clinical trial?

"Affirmative, the information on clinicaltrials.gov denotes that this experiment is presently enrolling patients. This endeavour was originally advertised on December 31st 2022 and its details were last updated on January 26th 2022. Specifically, 25 participants are sought from a single site."

Answered by AI

Are enrollees currently being accepted into this research program?

"Affirmative. Clinicaltrials.gov shows that this medical investigation, first advertised on December 31st 2022, is still enrolling patients. 25 individuals are needed from one particular site for the study to be successful."

Answered by AI

Has the [18F]FMISO PET/MRI imaging been validated by federal regulations?

"A score of 1 was given to [18F]FMISO PET/MRI imaging due to its Phase 1 status, implying that the safety and efficacy data is still limited."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI
Jonathan E McConathy 2025. "Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04332588.
~17 spots leftby Aug 2027
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