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

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05580835
• Other study ID #: 54382721.3.0000.0068
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2022
• Est. completion date: September 4, 2024

Study information

• Verified date: October 2022
• Source: University of Sao Paulo
• Contact: Irai S Oliveira, MD
• Phone: 5511993662208
• Email: irai.oliveira[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 4, 2024
• Est. primary completion date: September 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

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

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	GE Healthcare

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance of PET MRI - PSMA for HCC	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
Primary	Degree of PSMA uptake by HCC	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	Correlation of PSMA uptake and liver nodules histology	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
Secondary	Presence of PSMA uptake on treated liver lesions	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