Evaluating a new imaging technique for liver cancer
Single Centre Prospective Evaluation of 68Gallium-FAPI PET/MRI in Hepatocellular Carcinoma
This study is testing a new type of scan to see if it can better detect and understand liver cancer in patients compared to standard imaging methods.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | National University Hospital, Singapore Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT05687747 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 68Gallium-FAPI-46 PET/MRI in patients diagnosed with Hepatocellular Carcinoma (HCC). Patients will undergo both the PET/MRI scan and standard contrasted multiphasic MRI imaging to compare the results. The goal is to assess the new imaging technique's ability to detect, characterize, and stage liver lesions more accurately than traditional methods. This is a single-center, prospective evaluation aimed at improving diagnostic approaches for HCC.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-99 with a confirmed diagnosis of Hepatocellular Carcinoma who have not undergone prior locoregional therapy.
Not a fit: Patients with known active malignancies other than HCC or those who have had recent hepatic surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate detection and staging of liver cancer, potentially improving treatment outcomes for patients.
How similar studies have performed: While the use of PET/MRI in cancer imaging is gaining traction, this specific approach with 68Gallium-FAPI-46 is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Singapore
- Robert John Walsh — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Robert Walsh — National University Hospital, Singapore
- Study coordinator: Robert Walsh
- Email: robert_walsh@nuhs.edu.sg
- Phone: 6908-2222
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.