CancerNCT05889312
Assessing Cancer Treatment Response to Therapy Using 18F-FSPG PET
An observational study of Cancer and Diagnosis, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cancer, Diagnosis, Resistant Cancer
- What is being tested?
- 18F-FSPG PET/CT in NSCLC and 18F-FSPG PET/CT in HNSCC
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Feb 2025to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: stage 3 non-small cell lung cancer (NSCLC) stage 3 and 4 head and neck squamous cell cancer (HNSCC)
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London
Gary Cook
About this study
Official title: Improving Response Assessment in Cancer by Measurement of Cellular Redox Status Using 18F-FSPG Positron Emission Tomography
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:
- Written informed consent
- Aged 16 or above (as per NCRI)
- Histologically confirmed NSCLC and HNSCC, 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)
- Conditions
- Cancer, Diagnosis, Resistant Cancer, Response, Acute Phase
- Being tested
- 18F-FSPG PET/CT in NSCLC, 18F-FSPG PET/CT in HNSCC
- Medical subject headings
- Neoplasms, Disease, Acute-Phase Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FSPG PET/CT in NSCLCDiagnostic test
Stage 3 NSCLC with radical curative intent at baseline (pre-treatment) and at 4-8 weeks into treatment.
18F-FSPG PET/CT in HNSCCDiagnostic test
Stage 3 and 4 HNSCC with radical curative intent at baseline and at 2-4 weeks into treatment.
| Study group | Role | What they receive |
|---|---|---|
| Non-small cell lung cancer | NSCLC Receives: Diagnostic Test: 18F-FSPG PET/CT in NSCLC | |
| Head and neck squamous cell cancer | HNSCC Receives: Diagnostic Test: 18F-FSPG PET/CT in HNSCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (3)
18F-FSPG kinetics
- 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
Measured: 2 years
18F-FSPG heterogeneity
- Determine the baseline level and variability of 18F-FSPG uptake within and between patients with NSCLC and HNSCC pre and post treatment
Measured: 3 years
Correlation with histopathology and blood biomarkers
- 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start19 Feb 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889312
- Sponsor's protocol ID
- 312860
- Status last verified
- Apr 2025
- First submitted
- 16 May 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only anonymised data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Response Assessment in Cancer by Measurement of Cellular Redox Status Using 18F-FSPG Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT05889312
- Acronym / sponsor ID
- 312860
- Conditions
- Cancer, Diagnosis, Resistant Cancer, Response, Acute Phase
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Written informed consent
- Aged 16 or above (as per NCRI)
- Histologically confirmed NSCLC and HNSCC, 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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-small cell lung cancer | – | Diagnostic Test: 18F-FSPG PET/CT in NSCLCNSCLC |
| Head and neck squamous cell cancer | – | Diagnostic Test: 18F-FSPG PET/CT in HNSCCHNSCC |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- stage 3 non-small cell lung cancer (NSCLC) stage 3 and 4 head and neck squamous cell cancer (HNSCC)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FSPG PET/CT in NSCLCStage 3 NSCLC with radical curative intent at baseline (pre-treatment) and at 4-8 weeks into treatment. | Diagnostic test | Non-small cell lung cancer |
| 18F-FSPG PET/CT in HNSCCStage 3 and 4 HNSCC with radical curative intent at baseline and at 2-4 weeks into treatment. | Diagnostic test | Head and neck squamous cell cancer |
Primary outcome
Changes in tumour cellular redox status
Time frame: 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.
3 secondary outcomes
18F-FSPG kinetics
Time frame: 2 years
18F-FSPG heterogeneity
Time frame: 3 years
Correlation with histopathology and blood biomarkers
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No. Only anonymised data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Diagnosis, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gark Cook (0207 188 8364, gary.cook@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in tumour cellular redox status (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.