Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT05580835
Status:
UNKNOWN
Last Update Posted:
2022-10-14
First Post:
2022-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma
Sponsor:
University of Sao Paulo
Organization:
Study Overview
Official Title:
Added Value of PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: