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

Study Overview
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Brief Summary
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Prospective single centre non-randomised exploratory observational study 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.

Detailed Description
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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)

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

Conditions
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Cancer, Diagnosis, Resistant Cancer, Response, Acute Phase

Intervention / Treatment
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* Diagnostic Test: 18F-FSPG PET/CT in NSCLC
* Diagnostic Test: 18F-FSPG PET/CT in HNSCC


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-small cell lung cancer<br>NSCLC | Diagnostic Test: 18F-FSPG PET/CT in NSCLC<br>* Stage 3 NSCLC with radical curative intent at baseline (pre-treatment) and at 4-8 weeks into treatment.<br>|
| Head and neck squamous cell cancer<br>HNSCC | Diagnostic Test: 18F-FSPG PET/CT in HNSCC<br>* Stage 3 and 4 HNSCC with radical curative intent at baseline and at 2-4 weeks into treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in tumour cellular redox status | 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. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18F-FSPG kinetics | 1. Characterise the uptake and pharmacokinetics of 18F-FSPG in NSCLC and HNSCC by measurement of tumour and normal tissue time activity curves time to peak | 2 years | 
| 18F-FSPG heterogeneity | 2. Determine the baseline level and variability of 18F-FSPG uptake within and between patients with NSCLC and HNSCC pre and post treatment | 3 years | 
| Correlation with histopathology and blood biomarkers | 3. Correlation between 18F-FSPG PET/CT imaging standard measures of response (RECIST/PERCIST percent change) and percent change in other biomarkers (immunohistochemistry score and blood glutamate concentration) at baseline and during cancer treatment. | 3 years |