← Back to Search

Advanced PET/MRI Imaging for Breast Cancer

Phase < 1

Waitlist Available

Led By Janis O'Malley, MD

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

Triple negative breast cancer (TNBC) patients (biopsy-proven) stage II-IV eligible

Patients with >50% Programmed death-ligand 1 (PD-L1) positive

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

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate whether a certain imaging method can predict how well immunotherapy will work for patients with breast cancer. 20 patients will be recruited and their existing treatment plans will not be affected.

Who is the study for?

This trial is for adults aged 18-75 with stage II-IV triple negative breast cancer who are eligible for immunotherapy but haven't started it yet. They must have a lesion over 1 cm, not be pregnant or breastfeeding, and have good kidney function. It's not for those unable to consent, with MRI contraindications like certain metal implants or tattoos, allergies to gadolinium contrast agents, previous immunotherapy treatment, or if they weigh over 350 lbs.

What is being tested?

[18F]FMISO-PET combined with contrast-enhanced MRI is being tested in this study of 20 patients to see how well it can monitor the effects of immunotherapy on breast cancer without influencing treatment decisions. The imaging results may help design future larger trials.

What are the potential side effects?

Since the trial focuses on imaging techniques rather than new medications, side effects might include reactions to the PET tracer [18F]FMISO or MRI contrast agent (like mild allergic reactions), discomfort from lying still during scans, and potential risks associated with radiation exposure from PET.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have stage II-IV triple negative breast cancer.

Select...

My cancer is more than 50% PD-L1 positive.

Select...

I have a cancer lesion larger than 1 cm.

Select...

I have not started any immunotherapy treatments yet.

Select...

I am between 18 and 75 years old.

Exclusion Criteria

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

Select...

I cannot use the contrast dye ProHance due to health reasons.

Select...

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

Select...

I have received immunotherapy before or after surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 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.

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Breast [18F]FMISO-PET with contrast-enhanced magnetic resonance (MR)Experimental Treatment1 Intervention

The patient will have a plastic peripheral intravenous catheter placed in the arm for administration of 10 millicuries (mCi)/10milliliters (mL) \[18F\]FMISO (≤ 15 µg/injected dose) followed by an uptake of 120 minutes. The injection will be infused nominally over one minute followed by a saline flush. After uptake, the patient will be scanned on the PET/MR for 60 minutes and will receive a contrast injection of gadoteridol during the dynamic sequence of the exam. The patient can be scanned on the PET/CT if the PET/MR is unavailable. During this study patients will be scheduled for up to 3 imaging visits. The first imaging visit will be at baseline prior to starting immunotherapy and is required for study eligibility. If for some reason the patient cannot complete the remaining 2 imaging visits, only one additional imaging visit during the identified times is necessary to remain eligible.

0 / 8Eligibility criteria met