Clinical trial · Interventional
68 Ga PSMA PET/MRI for Hepatocellular Carcinoma
Pilot Study of Integrated Time-of-Flight (TOF) 68 GA-PSMA - Gadoxetate PET/MR for Evaluation of Hepatocellular Carcinoma
NCT03982407CI-TRIAL-00059746completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a pilot study to investigate the evaluate to use of a drug/radiopharmaceutical called Gallium-68 PSMA-11 (68Ga-PSMA-11) for use in PET/MRI evaluation of hepatocellular carcinoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-PSMA-11 PET/MRI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ga68 PSMA PET-MR
- description
- 68Ga labeled PSMA -11 (or PSMA-HBED\_CC) PET/MRI scan
- interventionNames
- Drug: 68Ga-PSMA-11 PET/MRI
Primary outcomes (1)
- measure
- Evaluation of PSMA PET-MR for identification of intra and extrahepatic hepatocellular carcinoma in patients
- timeFrame
- 18 months
- description
- Sensitivity of PSMA PET-MRI for detection of LI-RADS 5 (definitely HCC) lesions on a per-lesion basis with histopathology as the gold standard. We will perform a Radiologic-pathologic correlation comparing HCC PSMA SUVmax with tumor PSMA immunostaining positivity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients at risk for HCC with either an imaging diagnosis of HCC by ceCT or ceMRI (LI-RADS 5) confirmed by a board-certified abdominal radiologist or biopsy-proven HCC confirmed by a hepatobiliary pathologist * No prior treatment for HCC * Subjects who are expected to undergo surgical resection of the hepatic lesion(s) and/or liver transplant * Male or female with age greater than 18 years, with the capacity to give informed consent and willingness to provide a written consent. Exclusion Criteria: * Subjects requiring emergent surgery for a ruptured/bleeding HCC * Bilirubin \> 3.0 mg/dL, which is a contraindication for Gadoxetate, the MRI contrast agent * Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the PET scan. * Subjects with higher than the weight/size limitations of PET/MRI scanner. * Subjects with contraindication to MRI including: Subjects who have a heart pacemaker, subjects who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain, subjects who have implanted devices with magnets, subjects who have other implanted electronic devices, subjects who have deep brain stimulator, subjects who have vagal nerve stimulator, subjects with cochlear (ear) or auditory implants * Subjects with history of allergic response to radiocontrast media * Subjects with known history of claustrophobia.
References
Publications (0)
Data not yet available
No reference posted for this study.