Status:
COMPLETED
68Ga-PSMA-Dual-Contrast PET/MRI or PET/CT for Early Detection of Liver Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
United States Department of Defense
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 itse...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the feasibility and diagnostic performance of gallium Ga 68 gozetotide (68Ga PSMA)-dual contrast PET/MRI for detection and staging of hepatocellular carcinoma (HCC)...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04762888
Start Date
February 24 2021
End Date
June 26 2025
Last Update
October 31 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905