This early phase I trial studies two new imaging techniques called 11C-glutamine positron emission tomography (PET) and 18F-FSPG PET to determine where and to what degree the 11C-glutamine tracer and 18F-FSPG tracer accumulate in normal and cancer tissue in patients with head and neck squamous cell cancer. The standard imaging methods for head and neck cancers are magnetic resonance imaging (MRI)s and computed tomography (CT) scans. PET scans are more sensitive than these standard methods, which means that they may be better able to detect and help manage the disease. Information from this study may improve imaging methods so that tumors can be found when they are smaller, which may lead to earlier treatment and/or better treatment plans and management.
Additional locations may be listed on ClinicalTrials.gov for NCT05322135.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To evaluate the ability of carbon C 11 glutamine (11C-Gln) and fluorine F 18 florilglutamic acid (18F-FSPG) PET imaging to detect tumors in patients with head and neck squamous cell carcinoma (HNSCC).
SECONDARY OBJECTIVES:
I. To compare PET imaging data to standard-of-care MRI or CT.
II. To determine the tumor-to-background ratios (TBR) for 11C-Gln and 18F-FSPG.
III. To determine the safety of 11C-Gln.
EXPLORATORY OBJECTIVES:
I. To compare 11C-Gln PET/CT and 18F-FSPG PET/CT imaging to conventional 18F-FDG PET when feasible.
II. To compare uptake of 11C-Gln and 18F-FSPG between human papillomavirus (HPV)-positive and HPV-negative patients.
OUTLINE:
Patients receive carbon C 11 glutamine intravenously (IV) and undergo PET/CT over 1 hour. Beginning 3.5 hours after first PET/CT scan, patients receive fluorine F 18 florilglutamic acid IV and undergo PET/CT over 20 minutes.
After completion of study intervention, patients are followed up for 30 days.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorLesley Flynt
