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

Recruiting

• Conditions: Cancer; Diagnosis; Resistant Cancer; Response, Acute Phase
• Interventions: Diagnostic Test: 18F-FSPG PET/CT in HNSCC; Diagnostic Test: 18F-FSPG PET/CT in NSCLC

• Registration Number: NCT05889312
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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.

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:

1. Written informed consent

2. Aged 16 or above (as per NCRI)

3. Histologically confirmed NSCLC and HNSCC, who are treatment naïve and scheduled to commence standard of care treatment ((chemo)radiotherapy)

4. Willingness and ability to comply with scheduled study visits and tests

5. Confirmation of adequate function of all major organs and systems

Exclusion criteria :

1. Pregnant or lactating women

2. Concomitant uncontrolled medical conditions

3. Participants likely to require palliative radiotherapy within the first 12 weeks of treatment

4. Prognosis less than 3 months

5. Previous anti-cancer treatment (only treatment naïve patients eligible for inclusion)

Study Timeline

• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-05
• Study Start: 2025-02-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Head and neck squamous cell cancer	18F-FSPG PET/CT in HNSCC	HNSCC
Non-small cell lung cancer	18F-FSPG PET/CT in NSCLC	NSCLC

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
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

Trial Locations

Locations (1)

Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom