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

May 24, 2023 updated by: Guy's and St Thomas' NHS Foundation Trust

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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)

Study Type

Observational

Enrollment (Estimated)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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)

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-small cell lung cancer
NSCLC
Diagnostic test: 18F-FSPG PET/CT in NSCLC
Stage 3 NSCLC with radical curative intent at baseline (pre-treatment) and at 4-8 weeks into treatment.
Head and neck squamous cell cancer
HNSCC
Diagnostic test: 18F-FSPG PET/CT in HNSCC
Stage 3 and 4 HNSCC with radical curative intent at baseline and at 2-4 weeks into treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
18F-FSPG kinetics
Time Frame: 2 years
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
2 years
18F-FSPG heterogeneity
Time Frame: 3 years
2. Determine the baseline level and variability of 18F-FSPG uptake within and between patients with NSCLC and HNSCC pre and post treatment
3 years
Correlation with histopathology and blood biomarkers
Time Frame: 3 years
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 312860

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only anonymised data will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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