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

Diagnostic and Prognostic Role of 11C-Choline PET/CT and DWI MRI for Response Assessment in Patients Affected by Hepatocellular Carcinoma (HCC) and Candidate to TARE

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02519075

Enrollment

Registered

2015-08-10

Start date

2015-04-30

Completion date

2018-12-31

Last updated

2020-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocarcinoma

Keywords

Hepatocarcinoma, TARE, response assessment

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.

Interventions

OTHERNo intervention

Observational study

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026