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

NCT05889312 | Recruiting

• 1 other identifier: 312860
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Diagnosis; Resistant Cancer; Response, Acute Phase

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 18F-FSPG kinetics

  2 years

• 18F-FSPG heterogeneity

  3 years

• Correlation with histopathology and blood biomarkers

  3 years

Study Arms (2)

Non-small cell lung cancer

NSCLC

Diagnostic Test: 18F-FSPG PET/CT in NSCLC

Head and neck squamous cell cancer

HNSCC

Diagnostic Test: 18F-FSPG PET/CT in HNSCC

Interventions

18F-FSPG PET/CT in NSCLC DIAGNOSTIC_TEST

Stage 3 NSCLC with radical curative intent at baseline (pre-treatment) and at 4-8 weeks into treatment.

Non-small cell lung cancer

18F-FSPG PET/CT in HNSCC DIAGNOSTIC_TEST

Stage 3 and 4 HNSCC with radical curative intent at baseline and at 2-4 weeks into treatment.

Head and neck squamous cell cancer

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

stage 3 non-small cell lung cancer (NSCLC) stage 3 and 4 head and neck squamous cell cancer (HNSCC)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neoplasms; Disease; Acute-Phase Reaction

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation

Central Study Contacts

Gark Cook

CONTACT

0207 188 8364; gary.cook@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 5, 2023
• Study Start: February 19, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)