← 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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.

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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,581 Previous Clinical Trials

2,278,009 Total Patients Enrolled

32 Trials studying Breast Cancer

4,491 Patients Enrolled for Breast Cancer

Janis O'Malley, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

1 Previous Clinical Trials

25 Total Patients Enrolled

Media Library

[18F]FMISO-PET with contrast-enhanced MRI Clinical Trial Eligibility Overview. Trial Name: NCT04861077 — Phase < 1

Breast Cancer Research Study Groups: Breast [18F]FMISO-PET with contrast-enhanced magnetic resonance (MR)

Breast Cancer Clinical Trial 2023: [18F]FMISO-PET with contrast-enhanced MRI Highlights & Side Effects. Trial Name: NCT04861077 — Phase < 1

[18F]FMISO-PET with contrast-enhanced MRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT04861077 — Phase < 1

Frequently Asked Questions

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

Do the age restrictions for this trial cap at 80 years old?

"This research is enrolling individuals aged 18 or above, but not exceeding 75 years of age."

Answered by AI

Is enrollment currently open for this clinical investigation?

"According to clinicaltrials.gov, this trial is no longer actively recruiting participants; it was initially posted on June 1st 2023 and last updated November 15th 2022. In spite of that, there are over two thousand three hundred fifty-three other trials seeking enrolment right now."

Answered by AI

Am I eligible to contribute to this clinical investigation?

"This research trial is taking on 20 participants who suffer from triple negative breast neoplasms, between 18 and 75 years of age. The following are the major requirements for potential applicants: not currently pregnant or nursing, eligible for immunotherapy treatment with no prior exposure to it, willing to give consent in writing, have an estimated life expectancy of more than one year old, and be aged between 18-75."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)

Janis P. O'Malley, MD 2025. "Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04861077.