11C-Choline PET/CT and DWI MRI for Response Assessment of HCC Candidate to TARE

Completed

• Conditions: Hepatocarcinoma

• Registration Number: NCT02519075
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

Prospective exploratory study specifically investigating the diagnostic and predictive role of 11C-Choline PET/CT and DWI MRI for response assessment in patients affected by HCC and candidate to TARE. A minimum number of 20 patients will be considered for the analysis.

Detailed Description

For the study, all patients with a histological diagnosis of HCC and eligible for TARE, i.e. with liver predominant disease who are not eligible for curative surgery, after multidisciplinary discussion will be included. In all cases, patients will undergo 11C-Choline PET/CT and DWI MRI before starting radioembolization and will be subsequently restaged 3 months after treatment completion. A minimum number of 20 patients will be considered for the analysis.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-08-07
• Study First Posted: 2015-08-10
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-29
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• patients with a histological diagnosis of HCC and eligible for TARE, i.e. with liver predominant disease who are not eligible for curative surgery, after multidisciplinary discussion will be included;
• obtained informed consent

Exclusion Criteria

• patients age <18 years
• pregnancy or breast-feeding;
• patients affected by other malignancies within the last 3 years;
• disseminated extrahepatic disease;
• severely abnormal excretory liver function tests or ascites suggestive of liver failure;
• hepatopulmonary shunt >20%;
• vascular variants and abnormalities as demonstrated on pre-treatment angiography, which cannot be corrected by embolisation and which lead to reflux of hepatic arterial blood to the stomach, pancreas or bowel.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variation of SUVmax (Maximal Standardized Uptake Value) in patients undergoing TARE for HCC	Change from Baseline in SUVmax up to 3 months after TARE

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milano, Italy