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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

Must not have

Contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)

Unable to lie still on the imaging table for one (1) hour

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot use a specific dye (ProHance) for MRI scans due to health reasons.

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I cannot stay still for an hour on an imaging table.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Changes in ADC (mm2/sec) from MRI.

Changes in SER from MRI.

Changes in SUV from PET.

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met