Clinical Trial · NCT04861077

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

Overview

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.

Sponsor

University of Alabama at Birmingham

Phase

Early Phase 1

Contacts

Sebastian Eady (CONTACT)

smeady@uabmc.edu

205-996-2636

Janis O'Malley, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04861077

Drug / Compound

FMISO

Isotope(s):

Target(s):

Hypoxia

Ligand Class: Small Molecules

Eligibility

Inclusion

1. Patients must be ≥ 18 years old and ≤ 75 years old
\>50%Programmed death-ligand 1 (PD-L1) positive
May not be pregnant or breastfeeding
Triple negative breast cancer (TNBC) patients (biopsy-proven) stage II-IV eligible
Eligible for immunotherapy who are naïve to beginning any immunotherapy treatment

Exclusion

Weight over 350 lbs., due to the scanner bore size
Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
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.
Unable to lie still on the imaging table for one (1) hour
1. Inability to provide informed consent