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CompletedNCT03430635Updated Feb 13, 2018

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

An observational study in Hepatocellular Carcinoma, sponsored by Humanitas Clinical and Research Center. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-13.

Sponsored by Humanitas Clinical and Research Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
40
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Hepatocellular Carcinoma
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
40 participants (actual)
Patient registry
No

Interventions

  • ProcedureHepatectomy

    Surgery of the liver: removal of a given part of the liver affected by hepatocellular carcinoma

    Also known as: Hepatic resection; liver resection.

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What researchers measure

Primary outcomes

  1. Identification of PET/CT parameters that can be predictors of survival

    Identification of specific PET/CT parameters that can be used as independent predictors of overall and/or disease-free 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

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Lanza E, Donadon M, Felisaz P, Mimmo A, Chiti A, Torzilli G, Balzarini L, Lopci E. Refining the management of patients with hepatocellular carcinoma integrating 11C-choline PET/CT scan into the multidisciplinary team discussion. Nucl Med Commun. 2017 Oct;38(10):826-836. doi: 10.1097/MNM.0000000000000719. PubMed 28723716 ↗
  • Lopci E, Torzilli G, Poretti D, de Neto LJ, Donadon M, Rimassa L, Lanza E, Sabongi JG, Ceriani R, Personeni N, Palmisano A, Pedicini V, Comito T, Scorsetti M, Chiti A. Diagnostic accuracy of (1)(1)C-choline PET/CT in comparison with CT and/or MRI in patients with hepatocellular carcinoma. Eur J Nucl Med Mol Imaging. 2015 Aug;42(9):1399-407. doi: 10.1007/s00259-015-3079-5. Epub 2015 May 12. PubMed 25962590 ↗
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Registry details

Key details

Study ID
NCT03430635
Lead sponsor
Humanitas Clinical and Research Center
Responsible party
Matteo Donadon (Assistant Professor of Surgery, Humanitas Clinical and Research Center) — Principal investigator
First posted
Feb 13, 2018
Start date
Jan 1, 2010
Primary completion
Dec 31, 2015
Completion
Jan 31, 2016
Last update
Feb 13, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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