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

Primary Purpose

Carcinoma, Hepatocellular

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
PET MRI with PSMA
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carcinoma, Hepatocellular focused on measuring Positron Emission Tomography/Magnetic Resonance) (PET/MR), Magnetic resonance imaging, Hepatocellular carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET MRI - PSMA

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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
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

Full Information

First Posted
October 11, 2022
Last Updated
October 11, 2022
Sponsor
University of Sao Paulo
Collaborators
GE Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT05580835
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
September 4, 2023 (Anticipated)
Study Completion Date
September 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
GE Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
Positron Emission Tomography/Magnetic Resonance) (PET/MR), Magnetic resonance imaging, Hepatocellular carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PET MRI - PSMA
Arm Type
Experimental
Arm Description
Patients with an imaging diagnosis of HCC and submitted to PET MRI - PSMA
Intervention Type
Diagnostic Test
Intervention Name(s)
PET MRI with PSMA
Intervention Description
A whole-body PET using PSMA as a radiotracer associated to an upper abdomen MRI with gadoxetic acid as contrast agent
Primary Outcome Measure Information:
Title
Diagnostic performance of PET MRI - PSMA for HCC
Description
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.
Time Frame
24 months
Title
Degree of PSMA uptake by HCC
Description
For all liver lesions diagnosed as HCC, the degree of PSMA on PET uptake will be measured and correlated with available pathology information
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Correlation of PSMA uptake and liver nodules histology
Description
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
Time Frame
24 months
Title
Presence of PSMA uptake on treated liver lesions
Description
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
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irai S Oliveira, MD
Phone
5511993662208
Email
irai.oliveira@hc.fm.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Sabrina M Ando, MD
Phone
5511974777302
Email
sabrina.ando@hc.fm.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irai S Oliveira, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos Buchpiguel, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
University of Sao Paulo
City
São Paulo
ZIP/Postal Code
01246-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irai S Oliveira, MD
Phone
5511993662208
Email
irai.oliveira@hc.fm.usp.br
First Name & Middle Initial & Last Name & Degree
Sabrina M Ando, MD
Phone
5511974777302
Email
sabrina.ando@hc.fm.usp.br
First Name & Middle Initial & Last Name & Degree
Irai S Oliveira, MD
First Name & Middle Initial & Last Name & Degree
Sabrina M Ando, MD
First Name & Middle Initial & Last Name & Degree
Marcelo A Queiroz, MD
First Name & Middle Initial & Last Name & Degree
Carlos A Buchpiguel, MD

12. IPD Sharing Statement

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

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