Status:
COMPLETED
PSMA PET/MRI or PSMA PET/CT for Evaluation of Liver Cancer
Lead Sponsor:
Mayo Clinic
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This clinical trial evaluates whether 68Ga-PSMA PET/MRI or PET/CT can improve upon the diagnosis and management of liver cancer. MRI stands for magnetic resonance imaging, a scan that uses magnetic an...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate diagnostic performance of gallium Ga 68 gozetotide (68Ga-PSMA-dual contrast \[Gadavist and gadoxetate\]) positron emission tomography (PET)/magnetic resonance imagin...
Eligibility Criteria
Inclusion
- Patients with either an imaging diagnosis of HCC by CT or MRI (LI-RADS 5) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC
- Subjects who may undergo hepatic surgical resection, liver transplant, hepatic locoregional therapy (ablation, embolization, etc.) or systemic therapy
- No prior treatment for index HCC lesion (surgical resection, liver transplant, hepatic locoregional therapy arm)
- For the systemic therapy arm, patients who have had unequivocal progression after prior locoregional therapy (LRT) and/or those undergoing de novo systemic therapy in view of advanced HCC at diagnosis
- Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed consent
Exclusion
- Subjects 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 PET/MRI)
- 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 or PET/CT scanner
- Subjects with contraindication to MRI (relevant to PET/MRI):
- 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
Key Trial Info
Start Date :
June 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04310540
Start Date
June 5 2020
End Date
November 2 2023
Last Update
September 19 2024
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905