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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatocarcinoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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No intervention

Observational study

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No