Back to results

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

Primary Purpose

Hepatocellular Carcinoma

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Computed Tomography

Gallium Ga 68 Gozetotide

Magnetic Resonance Imaging

Positron Emission Tomography

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with either an imaging diagnosis of HCC by CT or MRI (Liver Imaging Reporting and Data System [LI-RADS] 5) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC
No prior treatment for HCC
Patients who may undergo hepatic surgical resection or liver transplant
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 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

Sites / Locations

Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (68Ga-PSMA PET/MRI or PET/CT)

Arm Description

Patients receive 68Ga-PSMA IV over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.

Outcomes

Primary Outcome Measures

Diagnostic performance of 68Ga-PSMA-dual contrast

Using surgical histopathology of resected or biopsied lesions and routine imaging surveillance (for lesions that cannot be resected or biopsied) as the gold standard, we will estimate the diagnostic performance (lesion-level sensitivity, specificity measures, and corresponding 95% confidence intervals) of PET/MRI for hepatic lesions and extra-hepatic metastases, and compare it with standard-of-care (SOC) imaging (MRI and CT) to identify the incremental benefit of PET/MRI.

Correlate biomarkers derived from PET/MRI with PSMA immuno-histochemical (IHC) grading

PSMA stained sections will be evaluated by light microscopy for PSMA localization and the entire section reviewed to determine percentage area of PSMA immunostaining as follows: 0 = no staining, 1 = < 5% staining, 2= 5 to 30% staining, 3 = 31 to 60% staining, and 4 = 61-100% staining. Grades 0-2 will be grouped as 'low PSMA expression' and grades 3 and 4 will be grouped as 'high PSMA expression'

Correlate biomarkers derived from PET/MRI with PSMA immuno-histochemical (IHC) grading

Intensity of PSMA uptake in hepatic lesions on PET will be graded as follows: grade 1: uptake < normal liver; grade 2: uptake = normal liver; grade 3: uptake > normal liver; grade 4: uptake > spleen or kidneys. For correlation with PSMA IHC scoring, grades 1 and 2 on PET/MRI will be grouped as 'low PSMA expression'. Conversely, grades 3 and 4 will be grouped as 'high PSMA expression'.

Secondary Outcome Measures

Full Information

NCT ID

NCT04762888

First Posted

February 11, 2021

Last Updated

June 26, 2023

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI), United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT04762888

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 24, 2021 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

February 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI), United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate the feasibility and diagnostic performance of gallium Ga 68 gozetotide (68Ga PSMA)-dual contrast PET/MRI for detection and staging of hepatocellular carcinoma (HCC), and to compare it with standard-of-care (SOC) imaging. II. To identify the biologic correlates of biomarkers derived from 68Ga PSMA-dual contrast PET/MRI with histopathology features and PSMA immunostaining of HCC. OUTLINE: Patients receive 68Ga-PSMA intravenously (IV) over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (68Ga-PSMA PET/MRI or PET/CT)

Arm Type

Experimental

Arm Description

Patients receive 68Ga-PSMA IV over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.

Intervention Type

Procedure

Intervention Name(s)

Computed Tomography

Other Intervention Name(s)

CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Intervention Description

Undergo PET/CT

Intervention Type

Drug

Intervention Name(s)

Gallium Ga 68 Gozetotide

Other Intervention Name(s)

(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

Intervention Description

Given IV

Intervention Type

Procedure

Intervention Name(s)

Magnetic Resonance Imaging

Other Intervention Name(s)

Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Intervention Description

Undergo PET/MRI

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography

Other Intervention Name(s)

Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Intervention Description

PET/MRI or PET/CT

Primary Outcome Measure Information:

Title

Diagnostic performance of 68Ga-PSMA-dual contrast

Description

Time Frame

Up to 6 weeks

Title

Correlate biomarkers derived from PET/MRI with PSMA immuno-histochemical (IHC) grading

Description

Time Frame

Up to 6 weeks

Title

Correlate biomarkers derived from PET/MRI with PSMA immuno-histochemical (IHC) grading

Description

Time Frame

Up to 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with either an imaging diagnosis of HCC by CT or MRI (Liver Imaging Reporting and Data System [LI-RADS] 5) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC No prior treatment for HCC Patients who may undergo hepatic surgical resection or liver transplant 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ajit H Goenka

Organizational Affiliation

Mayo Clinic in Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clinical Trials Referral Office

Phone

855-776-0015

mayocliniccancerstudies@mayo.edu

First Name & Middle Initial & Last Name & Degree

Ajit H. Goenka, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs