[18F]FPIA PET/CT Imaging in Patients With Solid Tumours

Launched by UNIVERSITY COLLEGE, LONDON · Jan 15, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a special imaging technique called \[18F\]FPIA PET/CT to see how well it can help us understand the growth of solid tumors in cancer patients. The goal is to find out how the body absorbs certain nutrients, known as short-chain fatty acids, and how this relates to the tumor's behavior. The study is currently looking for participants who have solid tumors and are scheduled for surgery within the next three months. To join, patients must be at least 18 years old, have tumors that are confirmed to be a certain size, and be in good health overall.

If you decide to participate, you will undergo two PET scans using this new imaging method before your surgery. It's important that you are not starting any cancer treatments like chemotherapy or radiotherapy during this time. Also, women of childbearing age will need to have a negative pregnancy test before participating. The study aims to gather important information that could help improve cancer treatment in the future, and participants will be closely monitored throughout the process.

Gender

ALL

Eligibility 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.