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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05889312
• Other study ID #: 312860
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: September 2026

Study information

• Verified date: May 2023
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Gark Cook
• Phone: 0207 188 8364
• Email: gary.cook[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: September 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute-Phase Reaction
• Cancer
• Diagnosis
• Resistant Cancer
• Response, Acute Phase

Intervention

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.
• 18F-FSPG PET/CT in HNSCC
Stage 3 and 4 HNSCC with radical curative intent at baseline and at 2-4 weeks into treatment.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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