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Trial Title:
PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma
NCT ID:
NCT05580835
Condition:
Carcinoma, Hepatocellular
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Positron Emission Tomography/Magnetic Resonance) (PET/MR)
Magnetic resonance imaging
Hepatocellular carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
PET MRI with PSMA
Description:
A whole-body PET using PSMA as a radiotracer associated to an upper abdomen MRI with
gadoxetic acid as contrast agent
Arm group label:
PET MRI - PSMA
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.
Criteria for 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Sao Paulo
Address:
City:
São Paulo
Zip:
01246-903
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Irai S Oliveira, MD
Phone:
5511993662208
Email:
irai.oliveira@hc.fm.usp.br
Contact backup:
Last name:
Sabrina M Ando, MD
Phone:
5511974777302
Email:
sabrina.ando@hc.fm.usp.br
Investigator:
Last name:
Irai S Oliveira, MD
Email:
Principal Investigator
Investigator:
Last name:
Sabrina M Ando, MD
Email:
Sub-Investigator
Investigator:
Last name:
Marcelo A Queiroz, MD
Email:
Sub-Investigator
Investigator:
Last name:
Carlos A Buchpiguel, MD
Email:
Sub-Investigator
Start date:
September 5, 2022
Completion date:
September 4, 2024
Lead sponsor:
Agency:
University of Sao Paulo
Agency class:
Other
Collaborator:
Agency:
GE Healthcare
Agency class:
Industry
Source:
University of Sao Paulo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05580835
