This phase I trial studies the usefulness of [18F]FMISO-PET/MRI in monitoring treatment response in patients with HER2+ stage II-III breast cancer who are receiving therapy before surgery. It is thought that many cancers contain areas with low oxygen. This lack of oxygen may affect the growth of cancer cells and the response to different cancer treatments. 18F]FMISO is a small molecule with a radioactive portion call fluorine-18 (18F). [18F]FMISO builds up in cells that do not have enough oxygen. PET is a type of imaging test that uses a small amount of radioactive drug injected into the vein to see how cells or tissues are functioning. It is combined with an MRI machine which uses magnetic fields and radio waves to generate images of the inside of the body. Diagnostic procedures, such as [18F]FMISO-PET/MRI, may help monitor and predict treatment response in patients with breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT04332588.
Locations matching your search criteria
United States
Alabama
Birmingham
University of Alabama at Birmingham Cancer CenterStatus: Active
Contact: Janis P. O'Malley
Phone: 205-934-1388
PRIMARY OBJECTIVES:
I. To determine the diagnostic quality of quantitative [18F]fluoromisonidazole (FMISO)-positron emission tomography (PET)/magnetic resonance imaging (MRI) with contrast to monitor response to neoadjuvant therapy in patients with newly diagnosed HER2+ locally advanced breast cancer.
II. To determine biologically relevant quantitative imaging metrics to predict changes in tumor microenvironment in response to targeted or combination therapies.
EXPLORATORY OBJECTIVES:
I. Quantify how tumor heterogeneity (through imaging metrics of biological alterations) changes throughout the course of therapy to identify spatial sub-regions of response or non-response to treatment.
II. Compare tumor changes at imaging time point 3 in cohort one to imaging time point two in cohort 2 to assess how monotherapy affects combination therapy to quantify how Herceptin alters the primary breast cancer tumor environment.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients receive [18F]FMISO intravenously (IV) over 1 minute, gadoteridol IV over less than 1 minute, and undergo PET/MRI over 90 minutes prior to starting therapy, after monotherapy but before combination therapy, and after cycle 1 but before cycle 2 of combination therapy.
COHORT II: Patients receive [18F]FMISO IV over 1 minute, gadoteridol IV over less than 1 minute, and undergo PET/MRI over 90 minutes prior to starting therapy and after cycle 1 but before cycle 2 of combination therapy.
After completion of study, patients are followed up every 6 months for up to 5 years.
Lead OrganizationUniversity of Alabama at Birmingham Cancer Center
Principal InvestigatorJanis P. O'Malley
