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

N/ACompletedNCT02519075

Istituto Clinico Humanitas14 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hepatocarcinoma

Interventions

No interventionOTHER

Observational study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Outcomes

Primary Outcomes

Variation of SUVmax (Maximal Standardized Uptake Value) in patients undergoing TARE for HCC

Time frame: Change from Baseline in SUVmax up to 3 months after TARE

Data from ClinicalTrials.gov

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