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RecruitingNCT05889312Updated Apr 4, 2025

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

An observational study in Cancer, Diagnosis and Resistant Cancer, sponsored by Guy's and St Thomas' NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
32
Ages
16 Years and older
Sex
All
01

Study 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.

Read the 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)
02

Conditions studied

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

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03

In context

Acute-Phase Reaction

21 studies on the registry are indexed under Acute-Phase Reaction; 4 are open to participants now.

Browse Acute-Phase Reaction studies →

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 284 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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)

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

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
32 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic test18F-FSPG PET/CT in NSCLC

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

  • Diagnostic test18F-FSPG PET/CT in HNSCC

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

06

What researchers measure

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.

    Time frame: 3 years

Secondary outcomes

  1. 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

    Time frame: 2 years

  2. 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

    Time frame: 3 years

  3. 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.

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Guy's and St Thomas' NHS Foundation Trust
    London, United Kingdom
    • Gary Cook · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Only anonymised data will be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05889312
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
King's College London
Responsible party
Sponsor
First posted
Jun 5, 2023
Start date
Feb 19, 2025
Primary completion
Sep 2026 (estimated)
Completion
Sep 2027 (estimated)
Last update
Apr 4, 2025

Study contacts

Gark Cook
Contact
gary.cook@kcl.ac.uk
0207 188 8364

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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