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

University of Sao Paulo

Status: Enrolling

Conditions: Carcinoma, Hepatocellular

Treatments: Diagnostic Test: PET MRI with PSMA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05580835

54382721.3.0000.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

PET MRI - PSMA

Experimental group

Description:

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

Treatment:

Diagnostic Test: PET MRI with PSMA