PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma

October 11, 2022 updated by: Irai Santana de Oliveira, University of Sao Paulo

Added Value of PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma

Assess the rate and degree of PSMA uptake in patients with hepatocellular carcinoma submitted to PET/MRI scans. The objective is to evaluate its value on diagnosis and staging of HCC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PET/MR - PSMA have emerged as a new method and there are few studies about its role in the evaluation of hepatocellular carcinoma (HCC).

The hypothesis in this study is that PET/MRI with PSMA might have an additional value in the assessment of hepatocellular carcinoma, contributing to the diagnosis of distant metastasis and to confirm the diagnosis in undetermined nodules by the standard exams (computed tomography and magnetic resonance imaging).

Patients with hepatocellular carcinoma diagnosed by computed tomography or magnetic resonance imaging and referred to a liver transplant or surgery by clinical decision wil be submitted to a whole-body PSMA-PET/MRI and will be included in this prospective unicentric study to be conducted at Instituto do Câncer do Estado de São Paulo (ICESP) and Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP).

All cases will be evaluated to determine the presence and degree of PSMA uptake on lesions considered as definitely HCCs by CT or MRI. The sensitivity of PSMA - PET/MR for the diagnosis of HCC will be calculated.

The added value of PSMA - PET MR on systemic staging will be calculated by the number of lesions considered suspicious for malignancy that were not detected by conventional scans.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 01246-903
        • Recruiting
        • University of Sao Paulo
        • Contact:
        • Contact:
        • Principal Investigator:
          • Irai S Oliveira, MD
        • Sub-Investigator:
          • Sabrina M Ando, MD
        • Sub-Investigator:
          • Marcelo A Queiroz, MD
        • Sub-Investigator:
          • Carlos A Buchpiguel, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with an imaging diagnosis of HCC by a previous CT or MRI, reviewed by an abdominal radiologist
  • Patients candidates to liver transplant or surgical resection

Exclusion Criteria:

  • Patients with treated liver lesion without viable tumor
  • Age under 18
  • Pregnancy
  • Patients with renal insufficiency;
  • Elevated bilirubin levels (>3 mg/dL)
  • Known allergy to contrast media (gadoxetic acid) or radiotracer (PSMA);
  • Blood glucose level higher than 150 mg/dl.
  • MR contraindications (claustrophobia, cardiac pacemakers, neurostimulators, cochlear implants, and insulin pumps).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PET MRI - PSMA
Patients with an imaging diagnosis of HCC and submitted to PET MRI - PSMA
Diagnostic test: PET MRI with PSMA
A whole-body PET using PSMA as a radiotracer associated to an upper abdomen MRI with gadoxetic acid as contrast agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of PET MRI - PSMA for HCC
Time Frame: 24 months
Patients with a liver lesion diagnosed as hepatocellular carcinoma by MRI or CT and candidates to surgical resection or liver transplant will be submitted to PET MRI with PSMA. Based on the presence or absence of PSMA uptake, sensitivity and specificity of PET MRI for diagnosis of the liver lesion and extrahepatic disease will be calculated.
24 months
Degree of PSMA uptake by HCC
Time Frame: 24 months
For all liver lesions diagnosed as HCC, the degree of PSMA on PET uptake will be measured and correlated with available pathology information
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of PSMA uptake and liver nodules histology
Time Frame: 24 months
All other non-HCC nodules simultaneously diagnosed will be also evaluated in terms of presence and degree of PSMA uptake. This results will be computed and correlated with all pathology data available
24 months
Presence of PSMA uptake on treated liver lesions
Time Frame: 24 months
Whenever a treated observation is present, the presence and degree of PSMA uptake will be evaluated and correlated to conventional imaging scans and pathology results available
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

GE Healthcare

Investigators

  • Principal Investigator: Irai S Oliveira, MD, University of Sao Paulo
  • Study Chair: Carlos Buchpiguel, PhD, University of Sao Paulo

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 Major Dates

Study Start (ACTUAL)

September 5, 2022

Primary Completion (ANTICIPATED)

September 4, 2023

Study Completion (ANTICIPATED)

September 4, 2024

Study Registration Dates

First Submitted

October 11, 2022

First Submitted That Met QC Criteria

October 11, 2022

First Posted (ACTUAL)

October 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 11, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 54382721.3.0000.0068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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