68Ga-PSMA-Dual-Contrast PET/MRI or PET/CT for Early Detection of Liver Cancer

Launched by MAYO CLINIC · Feb 16, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new imaging technique called 68Ga-PSMA PET/MRI or PET/CT to help detect liver cancer, specifically hepatocellular carcinoma (HCC), at an early stage. The goal is to see if this method, which uses a special radioactive tracer to target cancer cells, can provide clearer images and improve the diagnosis and treatment of liver cancer compared to standard methods. This trial is currently seeking participants aged 18 and older who have either been diagnosed with liver cancer through imaging tests or have a confirmed biopsy. Eligible patients should not have received prior treatment for their liver cancer.

If you decide to participate, you will undergo either a PET/MRI or PET/CT scan, depending on your individual situation and any medical conditions you may have. The trial aims to enhance our understanding of liver cancer detection, which could lead to better management of this condition in the future. It’s important to note that there are specific criteria for joining this study, such as not having certain medical conditions that could complicate imaging tests, and participants will need to provide informed consent before starting.

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Eligibility criteria

• 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.