PSMA PET/MRI or PSMA PET/CT for Evaluation of Liver Cancer

NCT ID: NCT04310540

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-05
• Study Completion Date: 2023-11-02

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 and radio waves to produce detailed structural information of the organs, tissues and structures within the body. PET stands for positron emission tomography, 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 (radiotracer) to show this activity. CT scan uses X-rays to create images of the bones and internal organs within the body. In patients that have been diagnosed with liver cancer, a protein called prostate specific membrane antigen (PSMA) appears in large amounts on the surface of the cancerous cells. The radioactive chemical compound (68Ga-PSMA) has been designed to circulate through the body and attach itself to the PSMA protein on liver cancer cells. 68Ga-PSMA PET/MRI or PET/CT may be better in diagnosing and managing liver cancer.

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 imaging (MRI) OR PET/computed tomography (CT) for hepatocellular carcinoma (HCC) using surgical histopathology (either resection, transplant or biopsy specimens) or Liver Imaging and Reporting Data System (LI-RADS) categorization as gold standard.

II. To evaluate treatment response after locoregional therapy or systemic therapy in HCC using 68Ga-PSMA uptake at PET (qualitative & semi-quantitative measures) and to compare it with standard CT/MRI morphologic and post-contrast enhancement based response criteria (modified Response Evaluation Criteria in Solid Tumors [mRECIST] and LI-RADS-treatment response [LR-TR] algorithm).

III. To determine association between PSMA uptake in HCCs at PET with tissue prostate specific membrane antigen (PSMA) expression using immunohistochemistry or serum/plasma PSMA expression using enzyme-linked immunosorbent assay (ELISA).

OUTLINE:

Patients receive gallium Ga 68 gozetotide intravenously (IV), and undergo PET/MRI over 60 minutes or PET/CT over 30 minutes at baseline and 12 weeks after completion of hepatic locoregional therapy or 8-12 weeks after completion of systemic therapy. Patients undergoing hepatic locoregional therapy may also undergo a liver biopsy.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (gallium Ga 68 gozetotide PET/MRI, PET/CT, biopsy)

Patients receive gallium Ga 68 gozetotide IV, and undergo PET/MRI over 60 minutes or PET/CT over 30 minutes at baseline and 12 weeks after completion of hepatic locoregional therapy or 8-12 weeks after completion of systemic therapy. Patients undergoing hepatic locoregional therapy may also undergo a liver biopsy.

Group Type: EXPERIMENTAL

Biopsy

Intervention Type: PROCEDURE

Undergo biopsy

Computed Tomography

Intervention Type: PROCEDURE

Undergo CT

Gallium Ga 68 Gozetotide

Intervention Type: DRUG

Given IV

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo MRI

Positron Emission Tomography

Intervention Type: PROCEDURE

Undergo PET

Interventions

Biopsy

Undergo biopsy

Intervention Type: PROCEDURE

Computed Tomography

Undergo CT

Intervention Type: PROCEDURE

Gallium Ga 68 Gozetotide

Given IV

Intervention Type: DRUG

Magnetic Resonance Imaging

Undergo MRI

Intervention Type: PROCEDURE

Positron Emission Tomography

Undergo PET

Intervention Type: PROCEDURE

Other Intervention Names

BIOPSY_TYPE; Bx; CAT; CAT Scan; Computed Axial Tomography; Computerized Axial Tomography; Computerized axial tomography (procedure); Computerized Tomography; CT; CT Scan; tomography; (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC; (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC; (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC; (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC; (68Ga)Glu-urea-Lys(Ahx)-HBED-CC; 68Ga-DKFZ-PSMA-11; 68Ga-HBED-CC-PSMA; 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC; 68Ga-PSMA; 68Ga-PSMA-11; 68Ga-PSMA-HBED-CC; [68Ga] Prostate-specific Membrane Antigen 11; [68Ga]GaPSMA-11; Ga PSMA; Ga-68 labeled DKFZ-PSMA-11; Ga-68 labeled PSMA-11; GA-68 PSMA-11; Gallium Ga 68 PSMA-11; Gallium Ga 68-labeled PSMA-11; GALLIUM GA-68 GOZETOTIDE; Gallium-68 PSMA; Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC; GaPSMA; PSMA-HBED-CC GA-68; Magnetic Resonance; Magnetic resonance imaging (procedure); Magnetic Resonance Imaging Scan; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; MR; MR Imaging; MRI; MRI Scan; NMR Imaging; NMRI; Nuclear Magnetic Resonance Imaging; Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron emission tomography (procedure); Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging; PT

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ajit H. Goenka, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2021-02760

Identifier Type: REGISTRY

Identifier Source: secondary_id

19-012563

Identifier Type: -

Identifier Source: org_study_id