NCT05687747RecruitingPhase 1
Single Centre Prospective Evaluation of 68Gallium-FAPI PET/MRI in Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 4 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Single centre prospective evaluation of 68Gallium(Ga68)-FAPI-46 PET/MRI in patients diagnosed with Hepatocellular Carcinoma (HCC). 68Gallium-FAPI-46 PET/MRI and standard contrasted multiphasic MRI imaging will be acquired in patients with radiological or histological diagnosis of HCC. The PET scan results will be compared to standard imaging to evaluate its role in lesion detection, characterisation and staging in patients with HCC.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 8 Jan 2023
- Start date
- 18 Aug 2023
- Primary completion date
- Aug 2025
- Lead sponsor
- National University Hospital, Singapore
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05687747
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 100
- From 18 Aug 2023 to the primary completion date, Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hepatic surgery within the last 30 days.
Other illness
- Allergy to 68Ga-FAPI contrast agents
- Contraindication to MRI, including but not limited to MRI incompatible metallic implants, cardiac pacemaker, claustrophobia
- Known active malignancy other than HCC
- Active inflammatory conditions that may affect FAPI imaging in opinion of investigator. Including but not limited to active infection, IgG4-related disease, inflammatory bowel disease,
Age
- Pregnancy (all women of childbearing age are required to undertake a urine pregnancy test)
Other
- Weight \> 150kg
Who the study is looking for
- Age 21-99 years
- Diagnosis of HCC based on histological assessment, or meeting consensus radiological criteria for diagnosis of HCC based on American Association for the Study of Liver Diseases practice guidelines(18)
- No prior locoregional therapy for HCC
- Creatinine clearance \> 30ml/min based on Cockcroft Gault formula
- Able to provide informed signed consent
Age in the registry: 21 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Robert John Walsh Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.