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

NCT04310540 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: 19-012563NCI-2021-02760
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

• Diagnostic performance of 68Ga-PSMA-dual contrast (gadavist and gadoxetate) positron emission tomography/magnetic resonance imaging (PET/MRI), or 68Ga-PSMA positron emission tomography/computed tomography (PET/CT)

  Using surgical histopathology (either resection or transplant specimens) or Liver Imaging and Reporting Data System (LI-RADS\[R\]) categorization as gold standard.

  At 3 months after completion of hepatic locoregional therapy or systemic therapy

• Treatment response after locoregional therapy in hepatocellular carcinoma (HCC)

  Using 68Ga-PSMA uptake at PET (qualitative \& semi-quantitative measures) compared with standard CT/MRI morphologic and post-contrast enhancement based response criteria (modified Response Evaluation Criteria in Solid Tumors and LI-RADS-treatment response \[LR-TR\] algorithm).

  Completion of locoregional therapy (up to 3 months)

• Association between prostate specific membrane antigen (PSMA) uptake in hepatocellular carcinoma at PET with tissue PSMA expression

  Assessed using immunohistochemistry, serum/plasma PSMA expression using enzyme-linked immunosorbent assay or serum HCC tumor markers.

  Up to 3 years

Study Arms (1)

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

EXPERIMENTAL

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.

Procedure: Biopsy; Procedure: Computed Tomography; Drug: Gallium Ga 68 Gozetotide; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

Interventions

Biopsy PROCEDURE

Undergo biopsy

Also known as: BIOPSY_TYPE, Bx

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

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography

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

Gallium Ga 68 Gozetotide DRUG

Given IV

Also known as: (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

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

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: 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

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

Positron Emission Tomography PROCEDURE

Undergo PET

Also known as: 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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Biopsy; gallium 68 PSMA-11; 68Ga-DKFZ-PSMA-11; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Ajit H. Goenka, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 17, 2020
• Study Start: June 5, 2020
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)