NCT05687747 Single Centre Prospective Evaluation of 68Gallium-FAPI PET/MRI in Hepatocellular Carcinoma
| NCT ID | NCT05687747 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | National University Hospital, Singapore |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-08-18 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2023-08-18 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Allergy to 68Ga-FAPI contrast agents * Contraindication to MRI, including but not limited to MRI incompatible metallic implants, cardiac pacemaker, claustrophobia * Weight \> 150kg * Known active malignancy other than HCC * Hepatic surgery within the last 30 days. * 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, * Pregnancy (all women of childbearing age are required to undertake a urine pregnancy test)
Contact & Investigator
Robert Walsh
PRINCIPAL INVESTIGATOR
National University Hospital, Singapore
Frequently Asked Questions
Who can join the NCT05687747 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 99 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05687747 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05687747 currently recruiting?
Yes, NCT05687747 is actively recruiting participants. Contact the research team at robert_walsh@nuhs.edu.sg for enrollment information.
Where is the NCT05687747 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT05687747 clinical trial?
NCT05687747 is sponsored by National University Hospital, Singapore. The principal investigator is Robert Walsh at National University Hospital, Singapore. The trial plans to enroll 100 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.