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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03430635
• Other study ID #: CholinePETforHCC
• Status: Completed
• Phase: N/A
• First received: January 20, 2018
• Last updated: February 6, 2018
• Start date: January 1, 2010
• Est. completion date: January 31, 2016

Study information

• Verified date: February 2018
• Source: Humanitas Clinical and Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 31, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Humanitas Clinical and Research Center

References & Publications (2)

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. — View Citation

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 ¹¹C-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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