drugset / Trial / NCT05322135

A Pilot Study of Glutamine PET Imaging of Head and Neck Squamous Cell Carcinoma

NCT05322135

Phase 0 Terminated 3 enrolled M.D. Anderson Cancer Center
NaSingle-groupOpen-labelDiagnostic

Summary

We propose a focused, prospective pilot clinical imaging trial to evaluate 11C-Gln PET/CT followed by 18F-FSPG PET/CT in 20 HNSCC patients. Imaging metrics that are common to PET (e.g. SUVmax, peak or mean) will be determined. This study will also allow the acquisition of additional safety and biodistribution data, as, to date, only a limited number of patients have been evaluated with 11C-Gln as a direct PET imaging biomarker of Gln uptake. To date, no adverse side effects have been observed. We do not anticipate any toxicity since this tracer is a naturally-occurring essential amino acid in high abundance and is administered at sub-pharmacologic doses. A long-term goal of these preliminary studies is to validate the utility of Gln PET imaging metrics for HNSCC and to expand this imaging technique to additional patients in prospective cohorts of patients with HNSCC.

Timeline

Start
2022-09-14
Primary completion
2025-03-07
Completion
2025-03-07

Drugs

EvaluationDrugModalityDoseRoute
Subject 11C-Glutamine Diagnostic / imaging agent Intravenous
Subject 18F-FSPG Diagnostic / imaging agent Intravenous