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

NCT04861077 | Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: IRB-300007307 R21-072Radiology Research Pilot Award
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study will investigate the utility of Fludeoxyglucose (18F) fluoromisonidazole (FMISO), in patients diagnosed with triple negative breast cancer (stage II-IV disease), to monitor and predict the effect of immunotherapy. This is a parallel imaging study to current treatment strategies and no clinical decisions or outcomes will be based on the imaging. If promising, this data will be used to design larger trials. A total of 20 patients will be recruited for this study. This trial will not designate the participant's treatment plan; they will be eligible based on their treatment plan designated from their oncologist.

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Baseline measure of PET standardized uptake value (SUV).

  Compare baseline metrics from PET/MRI

  Baseline

• Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.

  Compare baseline metrics from PET/MRI.

  Baseline

Study Arms (1)

Breast [18F]FMISO-PET with contrast-enhanced magnetic resonance (MR)

EXPERIMENTAL

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.

Drug: [18F]FMISO-PET with contrast-enhanced MRI

Interventions

[18F]FMISO-PET with contrast-enhanced MRI DRUG

Triple negative breast cancer patients that are planning to undergo immunotherapy and consent to this study will have 3 imaging visits. Imaging visit 1 will take place before the patients start immunotherapy. Imaging Visit 2 will take place after the patient completes the 1st cycle of immunotherapy and before they start their 2nd cycle. Imaging Visit 3 will take place when the patient completes the 2nd cycle of immunotherapy and before they start the 4th cycle.

Breast [18F]FMISO-PET with contrast-enhanced magnetic resonance (MR)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be ≥ 18 years old and ≤ 75 years old
• Triple negative breast cancer (TNBC) patients (biopsy-proven) stage II-IV eligible
• \>50%Programmed death-ligand 1 (PD-L1) positive
• Eligible for immunotherapy who are naïve to beginning any immunotherapy treatment
• May not be pregnant or breastfeeding
• Subjects must be willing to sign consent
• Adequate creatinine clearance per institutional guidelines and within 30 days
• Estimated life expectancy of greater than one year
• Patients must have one lesion with RECIST measurable disease (greater than 1 cm in diameter, measured from diagnostic breast MRI or staging CT)

You may not qualify if:

• Inability to provide informed consent
• Weight over 350 lbs., due to the scanner bore size
• Lactating, known or suspected pregnancy. Women with child-bearing potential must a have a negative serum Human chorionic gonadotropin (β-hCG) pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 24 hours of each PET imaging study.
• Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
• Unable to lie still on the imaging table for one (1) hour
• contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)
• Have received immunotherapy in the neoadjuvant or adjuvant setting

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB

Birmingham, Alabama, 35249, United States

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janis O'Malley, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian Eady

CONTACT

205-996-2636; smeady@uabmc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Advanced Imaging Facility, Director, Division of Molecular Imaging and Therapeutics Professor, Division of Molecular Imaging and Therapeutics

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)