The phase I trial studies how well 11C-glutamine and 18F-FSPG positron emission tomography (PET) imaging works in detecting tumors in patients with metastatic colorectal cancer compared to standard imaging methods such as magnetic resonance imaging (MRI) or computed tomography (CT) scanning.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03275974.
PRIMARY OBJECTIVE:
I. To evaluate the ability of carbon C 11 glutamine (11C-Gln) and fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET) imaging to predict response to EGFR-targeted therapy in patients with advanced wild-type RAS colorectal cancer (CRC).
SECONDARY OBJECTIVES:
I. To identify and quantify gene expression profiles and patterns that collectively, with confirmation by PET, will establish a ‘glutaminolysis gene signature.
II. To evaluate the ability of 11C-Gln and 18F-FSPG PET imaging to predict clinical efficacy following EGFR-targeted therapy in patients with advanced wild-type RAS CRC.
EXPLORATORY OBJECTIVE:
I. To compare 11C-Gln PET/computed tomography (CT) and 18F-FSPG PET/CT imaging to conventional fludeoxyglucose F 18 (18F-FDG) PET when feasible, although the stage IV metastatic (mCRC) setting may preclude this option in some patients.
OUTLINE:
Patients receive carbon C 11 glutamine intravenously (IV) and undergo PET imaging over 108 minutes. Beginning 2 hours to 7 days after carbon C 11 glutamine PET, patients receive fluorine F 18 L-glutamate derivative BAY94-9392 IV and also undergo PET imaging over 108 minutes.
After completion of study treatment, patients are followed up within 14 days and then every 3 months for up to 2 years.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorSimone Krebs
