COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 itself to the prostate- specific membrane antigen (PSMA) protein on liver cancer cells. Magnetic resonance imaging (MRI) is a scan that uses magnetic and radio waves to produce detailed structural information of the organs, tissues, and structures within the body. Positron emission tomography (PET) is an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (tracer) to show this activity. Computed tomography (CT) scan uses X-rays to create images of the bones and internal organs within your body. Combining a PET scan with an MRI or CT scan may help make the images easier to interpret. This trial may help determine if 68Ga- PSMA PET/MRI or PET/CT can improve upon the diagnosis and management of liver cancer in the future.

Official Title

Early Detection, Accurate Staging, and Biologic Characterization of HCC With Hybrid 68Ga-PSMA-Dual -Contrast PET/MRI and PET/CT Using Cyclotron-Produced 68Ga

Quick Facts

Study Start:2021-02-24

Study Completion:2025-06-26

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04762888

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

Ajit H. Goenka, M.D.

PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Ajit H. Goenka, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-24

Study Completion Date2025-06-26

Study Record Updates

Study Start Date2021-02-24

Study Completion Date2025-06-26

Terms related to this study

Additional Relevant MeSH Terms

Hepatocellular Carcinoma