Clinical trial · Interventional
68Ga-PSMA-Dual-Contrast PET/MRI or PET/CT for Early Detection of Liver Cancer
Early Detection, Accurate Staging, and Biologic Characterization of HCC With Hybrid 68Ga-PSMA-Dual -Contrast PET/MRI and PET/CT Using Cyclotron-Produced 68Ga
- 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 phase II trial studies how well 68Ga-PSMA PET/MRI or PET/CT works in early detection of liver cancer. 68Gallium-PSMA is a radioactive tracer designed to circulate through the body and attach itself to the prostate- specific membrane antigen (PSMA) protein on liver cancer cells. Magnetic resonance imaging (MRI) is a scan that uses magnetic and radio waves to produce detailed structural information of the organs, tissues, and structures within the body. Positron emission tomography (PET) is an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (tracer) to show this activity. Computed tomography (CT) scan uses X-rays to create images of the bones and internal organs within your body. Combining a PET scan with an MRI or CT scan may help make the images easier to interpret. This trial may help determine if 68Ga- PSMA PET/MRI or PET/CT can improve upon the diagnosis and management of liver cancer in the future.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Gallium Ga 68 Gozetotide | Drug | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (68Ga-PSMA PET/MRI or PET/CT)
- description
- Patients receive 68Ga-PSMA IV over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
- interventionNames
- Procedure: Computed Tomography
- Drug: Gallium Ga 68 Gozetotide
- Procedure: Magnetic Resonance Imaging
- Procedure: Positron Emission Tomography
Primary outcomes (3)
- measure
- Number of HCC Lesions With High PSMA Uptake on Baseline 68Ga-PSMA-11 PET
- timeFrame
- Baseline 68Ga-PSMA-11 PET performed within 4 weeks of recruitment.
- description
- Treatment-naïve hepatocellular carcinoma (HCC) lesions were evaluated qualitatively on baseline 68Ga-PSMA-11 PET. Grade 1 indicated uptake less than normal liver. Grade 2 indicated uptake equal to normal liver. Grade 3 indicated uptake greater than normal liver. Grade 4 indicated uptake greater than spleen or kidneys. High PSMA uptake was defined as grade 3 or 4. Low PSMA uptake was defined as grade 1 or 2.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with either an imaging diagnosis of Hepatocellular carcinoma (HCC) by Computed Tomography (CT) or Magnetic Resonance Imaging MRI (Liver Imaging Reporting and Data System \[LI-RADS\] 5) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC * Subjects who may undergo hepatic surgical resection, liver transplant, or hepatic locoregional therapy (LRT) (e.g., ablation, embolization, etc.) * No prior treatment for index HCC lesion (surgical resection, liver transplant, hepatic locoregional therapy arm). Patients that have been previously treated with HCC, but have new or reoccurring untreated lesions, are included in the study. * Male or female with age greater than 18 years, with the capacity and willingness to provide written informed consent. Exclusion Criteria: * Patients requiring emergent surgery for a ruptured/bleeding HCC * Bilirubin \> 3.0 mg/dL, which is a contraindication for Gadoxetate, the MRI contrast agent (relevant to positron emission tomography \[PET\]/MRI) * Patients with glomerular filtration rate (GFR) \< 30 ml/min/1.73m\^2, on dialysis, or with acute kidney injury * Pregnant and/or breast-feeding patients. A negative pregnancy test within 48 hours of the PET scan * Patients with higher than the weight/size limitations of PET/MRI or PET/CT scanner * Subjects with history of allergic response to Eovist or Gadavist * Subjects with known history of claustrophobia * Subjects with GFR \< 30 ml/min/1.73m\^2, on dialysis, or with acute kidney injury * Subjects with a history of severe hypersensitivity to Eovist or Gadavist * Patients with contraindication to MRI (relevant to PET/MRI): * Patients who have a heart pacemaker * Patients who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain * Patients who have implanted devices with magnets * Patients who have other implanted electronic devices * Patients who have deep brain stimulator * Patients who have vagal nerve stimulator * Patients with cochlear (ear) or auditory implants PSMA PET/CT will be an alternative in this study for patients who are unable to undergo PET/MRI for any reason but are otherwise eligible for the study.
References
Publications (1)
- RESULTThompson SM, Suman G, Torbenson MS, Chen ZE, Jondal DE, Patra A, Ehman EC, Andrews JC, Fleming CJ, Welch BT, Kurup AN, Roberts LR, Watt KD, Truty MJ, Cleary SP, Smoot RL, Heimbach JK, Tran NH, Mahipal A, Yin J, Zemla T, Wang C, Fogarty Z, Jacobson M, Kemp BJ, Venkatesh SK, Johnson GB, Woodrum DA, Goenka AH. PSMA as a Theranostic Target in Hepatocellular Carcinoma: Immunohistochemistry and 68 Ga-PSMA-11 PET Using Cyclotron-Produced 68 Ga. Hepatol Commun. 2022 May;6(5):1172-1185. doi: 10.1002/hep4.1861. Epub 2021 Nov 15. PMID 34783177