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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-05

Study Completion Date

2024-09-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients with an imaging diagnosis of hepatocellular carcinoma and candidates to a liver transplant or surgical resection will be submitted to a novel imaging scan, PET / MRI with PSMA. The role of this imaging scan on diagnosis and staging of HCC will be evaluated.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PET MRI - PSMA

Patients with an imaging diagnosis of HCC and submitted to PET MRI - PSMA

Group Type EXPERIMENTAL

PET MRI with PSMA

Intervention Type DIAGNOSTIC_TEST

A whole-body PET using PSMA as a radiotracer associated to an upper abdomen MRI with gadoxetic acid as contrast agent

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No