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

ConditionsCancerDiagnosisResistant CancerResponse, Acute Phase
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorGuy's and St Thomas' NHS Foundation Trust

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

stage 3 non-small cell lung cancer (NSCLC) stage 3 and 4 head and neck squamous cell cancer (HNSCC)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Non-small cell lung cancer1 intervention
Group B: Head and neck squamous cell cancer1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guy's and St Thomas' NHS Foundation Trust

Lead sponsor

King's College London

Collaborator

Source ClinicalTrials.gov
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