Clinical trial · Interventional
Comparison of Hepatic Intraarterial Versus Systemic Intravenous 68Ga-PSMA PET/CT for Detection of Hepatocellular Carcinoma
Intraindividual Comparison of Hepatic Intraarterial Versus Systemic Intravenous 68Ga-PSMAPET/CT in Patients With HCC: Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI requested
Summary
Brief summary (as posted)
This phase 0/1 study evaluates intraarterial administration of gallium Ga 68 gozetotide (68Ga-PSMA) for the detection of prostate-specific membrane antigen (PSMA) positive liver cancer by positron emission tomography (PET)/computed tomography (CT). 68Ga-PSMA is an imaging agent used with PET/CT scans to locate PSMA positive lesions. This study evaluates intraarterial administration of this agent, compared to intravenous administration.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gallium Ga 68 Gozetotide | Radiation | — | UNRESOLVED |
| Hepatic Artery Embolization | Procedure | — | UNRESOLVED |
| Positron Emission Tomography and Computed Tomography Scan | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (embolization, 68Ga-PSMA, PET/CT)
- description
- Patients undergoing clinically indicated hepatic artery embolization will receive 68Ga-PSMA intraarterially (IA) over 5 minutes. After 60-90 minutes, patients undergo PET/CT scan over 1 hour.
- interventionNames
- Radiation: Gallium Ga 68 Gozetotide
- Procedure: Hepatic Artery Embolization
- Procedure: Positron Emission Tomography and Computed Tomography Scan
Primary outcomes (1)
- measure
- Intraindividual intralesional difference in maximum standardized uptake value (SUVmax)
- timeFrame
- Up to 2 years
- description
- Intraindividual intralesional difference in maximum standardized uptake value (SUVmax) will be evaluated as fold change and absolute difference for a given lesion between intra-arterially (I.A.) and intravenous (I.V.) prostate-specific membrane antigen (PSMA) positron emission tomography (PET). Qualitative evaluation assesses the intensity of PSMA uptake in hepatic lesions, graded as follows: grade 1: uptake \< normal liver; grade 2: uptake = normal liver; grade 3: uptake \> normal liver; grade 4: uptake \> spleen or kidneys. Semi-quantitative analysis is undertaken by calculating intraindividual difference in SUVmax for each lesion between I.A. and I.V. PSMA PET followed by a two-sided one sample t-test. Maximum and mean standardized uptake value (SUVmax, SUVmean, SUVmin) of the lesion(s), and SUVmax of the background liver are noted.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with either an imaging diagnosis of HCC by CT or magnetic resonance imaging (MRI) (Liver Imaging and Reporting Data System 5 \[LI-RADS 5\]) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC * Already enrolled in ongoing Transform the Practice or Department of Defense 68Ga-PSMA studies * PSMA avid HCC detected by 68Ga-PSMA PET/CT after intravenous administration of 68Ga-PSMA confirmed by a board certified nuclear radiologist * Undergoing planned hepatic artery embolization (HAE) per standard clinical care * Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed consent Exclusion Criteria: * Subjects requiring emergent surgery for a ruptured/bleeding HCC * 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/CT scanner
References
Publications (0)
Data not yet available