Assessing Cancer Treatment Response to Therapy Using 18F-FSPG PET
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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:
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Written informed consent
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Aged 16 or above (as per NCRI)
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Histologically confirmed NSCLC and HNSCC, who are treatment naïve and scheduled to commence standard of care treatment ((chemo)radiotherapy)
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Willingness and ability to comply with scheduled study visits and tests
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Confirmation of adequate function of all major organs and systems
Exclusion criteria :
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Pregnant or lactating women
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Concomitant uncontrolled medical conditions
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Participants likely to require palliative radiotherapy within the first 12 weeks of treatment
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Prognosis less than 3 months
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Previous anti-cancer treatment (only treatment naïve patients eligible for inclusion)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Non-small cell lung cancer NSCLC |
Diagnostic Test: 18F-FSPG PET/CT in NSCLC
Stage 3 NSCLC with radical curative intent at baseline (pre-treatment) and at 4-8 weeks into treatment.
|
| Head and neck squamous cell cancer HNSCC |
Diagnostic Test: 18F-FSPG PET/CT in HNSCC
Stage 3 and 4 HNSCC with radical curative intent at baseline and at 2-4 weeks into treatment.
|
Outcome Measures
Primary Outcome Measures
- Changes in tumour cellular redox status [3 years]
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 Outcome Measures
- 18F-FSPG kinetics [2 years]
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
- 18F-FSPG heterogeneity [3 years]
2. Determine the baseline level and variability of 18F-FSPG uptake within and between patients with NSCLC and HNSCC pre and post treatment
- Correlation with histopathology and blood biomarkers [3 years]
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.
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- King's College London
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 312860