Status:
UNKNOWN
[18F]FPIA PET/CT Imaging in Patients With Solid Tumours
Lead Sponsor:
University College, London
Collaborating Sponsors:
Cancer Research UK
Imperial College London
Conditions:
Cancer
Tumor, Solid
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study will be a phase 2, open-label study in patients with solid tumours to explore the relationship between short-chain fatty acid uptake using \[18F\]FPIA PET/CT and tumour proliferation
Detailed Description
Cancers have increased energy demands to allow for their rapid growth compared to healthy cells. Glucose is the main source of energy for many cells in the body, and clinicians routinely use a scan wh...
Eligibility Criteria
Inclusion
- Patients with radiological evidence of solid primary or metastatic target tumour lesions and the following characteristics will be recruited:
- Age ≥18 years of age
- Radiologically confirmed tumour size ≥15mm (at least one lesion must be extra-hepatic)
- The participant is due to undergo surgery within 3 months of the first \[18F\]FPIA PET/CT
- There is time to complete the two research PET studies without any delay to surgery
- WHO performance status 0 -2
- 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
- The participant is able and willing to comply with study procedures, and signed and dated informed consent is obtained.
- eGFR of ≥30 within 3 months of \[18F\]FPIA injection.
- The participant is not scheduled to start cancer treatment (e.g. chemotherapy, radiotherapy, biological therapy or immunotherapy) within the study scanning period.
Exclusion
- 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.
Key Trial Info
Start Date :
December 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04717674
Start Date
December 7 2021
End Date
October 1 2024
Last Update
October 3 2023
Active Locations (3)
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1
Guy's & St. Thomas' NHS Foundation Trust
London, United Kingdom
2
Imperial College Healthcare NHS Trust
London, United Kingdom
3
The Royal Marsden NHS Foundation Trust
London, United Kingdom