A Study to Develop and Validate Hybrid Molecular Imaging to Transform the Care of Hepatocellular Carcinoma Patients
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 19-012563
NCT ID: NCT04310540
Sponsor Protocol Number: 19-012563
About this study
The primary purpose of this study is to evaluate diagnostic performance of 68Ga-PSMA-dual contrast (gadavist and gadoxetate) PET/MRI OR PET/CT for HCC using surgical histopathology (either resection, transplant or biopsy specimens) or LI-RADS® categorization as gold standard.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- 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 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.
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Ajit Goenka, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available