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Trial Title:
Assessing Cancer Treatment Response to Therapy Using 18F-FSPG PET
NCT ID:
NCT05889312
Condition:
Cancer
Diagnosis
Resistant Cancer
Response, Acute Phase
Conditions: Official terms:
Acute-Phase Reaction
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
18F-FSPG PET/CT in NSCLC
Description:
Stage 3 NSCLC with radical curative intent at baseline (pre-treatment) and at 4-8 weeks
into treatment.
Arm group label:
Non-small cell lung cancer
Intervention type:
Diagnostic Test
Intervention name:
18F-FSPG PET/CT in HNSCC
Description:
Stage 3 and 4 HNSCC with radical curative intent at baseline and at 2-4 weeks into
treatment.
Arm group label:
Head and neck squamous cell cancer
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.
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)
Criteria for eligibility:
Study pop:
stage 3 non-small cell lung cancer (NSCLC) stage 3 and 4 head and neck squamous cell
cancer (HNSCC)
Sampling method:
Non-Probability Sample
Criteria:
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)
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 2023
Completion date:
September 2026
Lead sponsor:
Agency:
Guy's and St Thomas' NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
King's College London
Agency class:
Other
Source:
Guy's and St Thomas' NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05889312
