Clinical trial NCT05889312: Assessing Cancer Treatment Response to Therapy Using 18F-FSPG PET
Official title: Improving Response Assessment in Cancer by Measurement of Cellular Redox Status Using 18F-FSPG Positron Emission Tomography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Diagnosis
Resistant Cancer
Response, Acute Phase
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2023-06-05
Enrollment: 32
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

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)

Eligibility 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)

Primary outcomes:
measure: Changes in tumour cellular redox status
timeFrame: 3 years
Secondary outcomes:
measure: 18F-FSPG kinetics
timeFrame: 2 years
measure: 18F-FSPG heterogeneity
timeFrame: 3 years
measure: Correlation with histopathology and blood biomarkers
timeFrame: 3 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
References: