Using advanced imaging to detect liver cancer early
Early Detection, Accurate Staging, and Biologic Characterization of HCC with Hybrid 68Ga-PSMA-Dual -Contrast PET/MRI and PET/CT Using Cyclotron-Produced 68Ga
This study is testing if a new type of imaging can help find liver cancer earlier and more accurately in people at risk for the disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04762888 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of 68Ga-PSMA PET/MRI and PET/CT in the early detection of hepatocellular carcinoma (HCC). The study involves administering a radioactive tracer that targets cancer cells, followed by advanced imaging techniques to assess the presence and stage of liver cancer. The goal is to determine if these imaging methods can provide better diagnostic accuracy compared to standard imaging practices. Additionally, the study aims to correlate imaging findings with biological markers and histopathological features of HCC.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with imaging-diagnosed or biopsy-proven hepatocellular carcinoma who are eligible for surgical or locoregional therapies.
Not a fit: Patients requiring emergency surgery for a ruptured or bleeding HCC may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of liver cancer, potentially enhancing patient outcomes.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for cancer detection, suggesting this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Ajit H. Goenka, M.D. — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.