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

Study design: Prospective single centre non-randomised exploratory observational study.

Number of patients: 32 (16 head and neck cancer, 16 lung cancer).

Primary hypothesis: Changes in 18F-FSPG uptake predict treatment efficacy.

Primary objectives: To measure changes in tumour cellular redox status with 18F-FSPG PET in stage 3 non-small cell lung cancer (NSCLC) and stage 3 and 4 head and neck squamous cell cancer (HNSCC) at baseline and during standard of care treatment, and to compare this with 18F-FDG PET/CT and RECIST 1.1 response at 12 weeks.

Secondary objectives: Characterise the uptake and pharmacokinetics of 18F-FSPG in NSCLC and HNSCC patients.

Determine the baseline level and variability of 18F-FSPG uptake within and between patients with NSCLC and HNSCC pre and post treatment.

Compare 18F-FSPG PET/CT imaging with standard measures of response (RECIST/PERCIST) and other clinical biomarkers (IHC and blood glutamate) at baseline and during cancer treatment.

Primary outcomes: Report and compare % change in 18F-FSPG uptake in NSCLC and HNSCC patients on standard of care treatment with standard measures of response (RECIST/PERCIST) Secondary outcomes: Report variation in 18F-FSPG uptake in NSCLC and HNSCC. Report kinetic data in 18F-FSPG uptake in NSCLC and HNSCC. Report correlation of 18F-FSPG uptake in NSCLC and HNSCC with available histology and blood markers.

Inclusion criteria

• Written informed consent
• Aged 16 or above (as per NCRI)
• Histologically confirmed NSCLC and HNSCC, who are treatment naïve and scheduled to commence standard of care treatment ((chemo)radiotherapy)
• Willingness and ability to comply with scheduled study visits and tests
• Confirmation of adequate function of all major organs and systems

Exclusion criteria

• Pregnant or lactating women
• Concomitant uncontrolled medical conditions
• Participants likely to require palliative radiotherapy within the first 12 weeks of treatment
• Prognosis less than 3 months
• Previous anti-cancer treatment (only treatment naïve patients eligible for inclusion)

Inclusion criteria

• Written informed consent
• Aged 16 or above
• Histologically confirmed HNSCC or NSCLC, who are treatment naïve and scheduled to commence standard of care treatment ((chemo)radiotherapy)
• Willingness and ability to comply with scheduled study visits and tests
• Confirmation of adequate function of all major organs and systems

Exclusion criteria

• Pregnant or lactating women
• Concomitant uncontrolled medical conditions
• Participants likely to require palliative radiotherapy within the first 12 weeks of treatment
• Prognosis less than 3 months
• Previous anti-cancer treatment (only treatment naïve patients eligible for inclusion)