Role of Choline PET/CT in Predicting Survival in Patients With Hepatocellular Carcinoma

February 6, 2018 updated by: Matteo Donadon, Humanitas Clinical and Research Center

What is the Prognostic Value of ¹¹C-choline PET/CT in Patients Undergoing Hepatectomy for Hepatocellular Carcinoma?

¹¹C-choline positron emission tomography/computed tomography (PET/CT) has been used in patients with some types of solid cancers, but few data are available in patients undergoing hepatectomy for hepatocellular carcinoma (HCC). The aim of this study was to analyze the prognostic value of metabolic imaging data by using ¹¹C-choline PET/CT in patients with HCC before hepatectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our prospectively maintained liver unit database was queried for patients with HCC preoperatively staged with ¹¹C-choline PET/CT. This metabolic imaging modality was performed in addition to standard abdominal CT or magnetic resonance imaging. Several PET/CT parameters were recorded and analyzed. Univariate and multivariate analyses were performed to identify whether those PET/CT parameters could be predictors of overall survival (OS) and disease-free survival (DFS) of HCC patients.

Study Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients affected by HCC candidate to surgical resection that were preoperatively staged with ¹¹C-choline PET/CT.

Description

Inclusion Criteria:

  • Any patient with HCC candidate to surgical resection preoperatively staged with ¹¹C-choline PET/CT

Exclusion Criteria:

  • R2 resection;
  • Intraoperative use of RFA/MWI
  • Postoperative death (90-days)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of PET/CT parameters that can be predictors of survival
Time Frame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first assessed up to 72 months
Identification of specific PET/CT parameters that can be used as independent predictors of overall and/or disease-free survival
From date of surgery until the date of first documented progression or date of death from any cause, whichever came first assessed up to 72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanitas Clinical and Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

January 31, 2016

Study Registration Dates

First Submitted

January 20, 2018

First Submitted That Met QC Criteria

February 6, 2018

First Posted (Actual)

February 13, 2018

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CholinePETforHCC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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