Clinical trial NCT05580835: PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma
Official title: Added Value of PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Hepatocellular
Keywords: Positron Emission Tomography/Magnetic Resonance) (PET/MR)
Magnetic resonance imaging
Hepatocellular carcinoma
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2022-10-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Diagnostic performance of PET MRI - PSMA for HCC
timeFrame: 24 months
measure: Degree of PSMA uptake by HCC
timeFrame: 24 months
Secondary outcomes:
measure: Correlation of PSMA uptake and liver nodules histology
timeFrame: 24 months
measure: Presence of PSMA uptake on treated liver lesions
timeFrame: 24 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Irai S Oliveira, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Carlos Buchpiguel, PhD
role: STUDY_CHAIR
References: