Improving Response Assessment in Cancer by Measurement of Cellular Redox Status Using 18F-FSPG Positron Emission Tomography

What this Trial Is About

Researchers are conducting a prospective, single-center, non-randomized observational study to measure changes in tumor cellular redox status using 18F-FSPG PET scans in patients with stage 3 non-small cell lung cancer (NSCLC) and stage 3 and 4 head and neck squamous cell cancer (HNSCC). The study aims to evaluate how these changes correlate with standard imaging (18F-FDG PET/CT) and tumor response assessed by RECIST 1.1 criteria at 12 weeks during standard cancer treatment. This research also seeks to understand the uptake and pharmacokinetics of 18F-FSPG in these cancers and compare imaging results with clinical biomarkers. Participants will undergo 18F-FSPG PET/CT scans before treatment and during treatment: for NSCLC patients at baseline and 4-8 weeks into treatment, and for HNSCC patients at baseline and 2-4 weeks into treatment. The study involves 32 patients divided equally between the two cancer types. All patients will receive standard of care treatment, such as chemotherapy and radiotherapy, without any experimental therapy being administered as part of this study. During the study, participants will attend scheduled visits for imaging and assessments. Researchers will collect data on tumor redox changes, kinetic behavior of the tracer, and tumor heterogeneity. They will also compare imaging findings with histopathology and blood biomarkers. The study will monitor patients over a period of up to three years to assess changes and correlations. Participants must be able to comply with study visits and have adequate organ function. Safety and treatment response will be observed without altering standard care.

Assessing Cancer Treatment Response to Therapy Using 18F-FSPG PET