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

NCT05580835 | Unknown

• 1 other identifier: 54382721.3.0000.0068
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Hepatocellular

Keywords

Positron Emission Tomography/Magnetic Resonance) (PET/MR); Magnetic resonance imaging; Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Correlation of PSMA uptake and liver nodules histology

  24 months

• Presence of PSMA uptake on treated liver lesions

  24 months

Study Arms (1)

PET MRI - PSMA

EXPERIMENTAL

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

Diagnostic Test: PET MRI with PSMA

Interventions

PET MRI with PSMA DIAGNOSTIC_TEST

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

PET MRI - PSMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Sao Paulo: lead
• GE Healthcare: collaborator

Study Sites (1)

University of Sao Paulo

São Paulo, 01246-903, Brazil

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Irai S Oliveira, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Carlos Buchpiguel, PhD

  University of Sao Paulo

  STUDY CHAIR

Central Study Contacts

Irai S Oliveira, MD

CONTACT

5511993662208; irai.oliveira@hc.fm.usp.br

Sabrina M Ando, MD

CONTACT

5511974777302; sabrina.ando@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: September 5, 2022
• Primary Completion: September 4, 2023
• Study Completion: September 4, 2024
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

BR (1)