At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- 18F-FSPG PET/CT in NSCLC (diagnostic test), 18F-FSPG PET/CT in HNSCC (diagnostic test)
- How long the study runs
- Study runs about 31 months (dates as stated)
- About the drug or intervention
- 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. · 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.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 16 Years and over
- Who
- All
- Number of participants
- 32
- Started
- 2025-02-19
- Last checked
- 2025-04
Plain English Summary
What is this study?
- • Testing a new treatment for cancer
- • Clinical study - 32 participants
- • 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
Who can take part?
- • Ages 16 Years and over
- • Diagnosed with cancer
Where?
- • London - Guy's and St Thomas' NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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)
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years and over
- Who can join: All genders
What the study is looking for
- ✓Written agreement to take part
- ✓Aged 16 or above
- ✓confirmed by a biopsy HNSCC or NSCLC, who are treatment naïve and scheduled to commence the usual treatment...
- ✓Willingness and ability to comply with scheduled study visits and tests
- ✓Confirmation of adequate function of all major organs and systems
Who cannot take part
- ✗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)
See the full criteria
Where Is This Study? (1 UK site)
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
How to Get in Touch
Gark Cook
Sponsor contactCONTACT