Imaging cancer energy use with a special PET/CT scan
An Investigation of Short-chain Fatty Acid Uptake in Solid Tumours as Assessed by [18F]Fluoropivalate Positron Emission Tomography and Its Relationship With Tumour Proliferation
This study is testing a special PET/CT scan to see how solid tumors use fatty acids for energy compared to glucose, helping researchers understand cancer growth better for patients with these tumors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 3 sites (London and 2 other locations) |
| Trial ID | NCT04717674 on ClinicalTrials.gov |
What this trial studies
This phase 2, open-label study investigates the relationship between short-chain fatty acid uptake and tumor proliferation in patients with solid tumors. It utilizes a PET/CT scan to assess how different cancers utilize fatty acids for energy, which may differ from the conventional glucose metabolism. Patients will undergo two PET/CT scans within a short timeframe before any new treatment, allowing researchers to evaluate the consistency of the imaging results. Additionally, tumor tissue samples collected during routine surgeries will be analyzed to identify specific substances related to cancer biology and growth, facilitating a comparison with the imaging results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with radiologically confirmed solid tumors that are scheduled for surgery within three months.
Not a fit: Patients with tumors smaller than 15mm or those not scheduled for surgery within the study timeframe may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding of cancer metabolism and lead to more effective treatment strategies for patients with solid tumors.
How similar studies have performed: While the approach of using PET/CT imaging for fatty acid metabolism in cancer is relatively novel, similar imaging techniques have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with radiological evidence of solid primary or metastatic target tumour lesions and the following characteristics will be recruited: 1. Age ≥18 years of age 2. Radiologically confirmed tumour size ≥15mm (at least one lesion must be extra-hepatic) 3. The participant is due to undergo surgery within 3 months of the first \[18F\]FPIA PET/CT 4. There is time to complete the two research PET studies without any delay to surgery 5. WHO performance status 0 -2 6. If female, the participant is either post-menopausal (\>1 year), or surgically sterilised (has had a documented bilateral oophorectomy and/or documented hysterectomy, \>2 years), or if of childbearing potential, must have a negative urine pregnancy test within 2 hours prior to injection of imaging agent 7. The participant is able and willing to comply with study procedures, and signed and dated informed consent is obtained. 8. eGFR of ≥30 within 3 months of \[18F\]FPIA injection. 9. The participant is not scheduled to start cancer treatment (e.g. chemotherapy, radiotherapy, biological therapy or immunotherapy) within the study scanning period. Exclusion Criteria: * 1. The participant has received chemotherapy, immunotherapy, biologic therapy or investigational therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of \[18F\]FPIA injection or is due neoadjuvant therapy between the PET and surgery. 2. The participant is pregnant or lactating. 3. The participant is scheduled to have a nuclear medicine or contrast scan within 24 hours before the administration of \[18F\]FPIA. 4. Participants with claustrophobia or who are unable to comfortably tolerate the scanning procedure.
Where this trial is running
London and 2 other locations
- Guy's & St. Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
- The Royal Marsden NHS Foundation Trust — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Tara Barwick — University College, London
- Study coordinator: Laura McLeavy
- Email: ncita.fpia@ucl.ac.uk
- Phone: 0203 313 3720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.