NCT03430635

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

6 years

First QC Date

January 20, 2018

Last Update Submit

February 6, 2018

Conditions

Outcome Measures

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

    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

Interventions

HepatectomyPROCEDURE

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

Also known as: Hepatic resection; liver resection.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 28723716BACKGROUND
  • 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.

    PMID: 25962590BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

January 20, 2018

First Posted

February 13, 2018

Study Start

January 1, 2010

Primary Completion

December 31, 2015

Study Completion

January 31, 2016

Last Updated

February 13, 2018

Record last verified: 2018-02