NCT01639703

Brief Summary

The purpose of this study is to prospectively determine the diagnostic value of Xenetix-CT perfusion for the discrimination between well-differentiated hepatocellular carcinomas (HCC) and poorly/moderately differentiated HCC, in histo-pathologically proven HCC, and with the aim to cover the entire liver.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P25-P50 for phase_4 hepatocellular-carcinoma

Timeline
Completed

Started Apr 2012

Geographic Reach
4 countries

5 active sites

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

April 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

July 13, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

2.5 years

First QC Date

July 6, 2012

Results QC Date

December 16, 2016

Last Update Submit

July 11, 2017

Conditions

Hepatocellular Carcinoma

Keywords

CT perfusionHepatocellular CarcinomaXenetixContrast agent

Outcome Measures

Primary Outcomes (3)

  • Blood Volume (BV) According to Degree of Lesions Differentiation

    The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.

    Within a week from CT perfusion to surgery

  • Blood Flow (BF) According to Degree of Lesions Differentiation

    The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.

    Within a week from CT perfusion to surgery

  • Permeability Surface (PS) According to Degree of Lesions Differentiation

    The mean level of each CT perfusion parameter was compared between well differentiated and moderately/poorly differentiated lesions according to WHO classification evaluated off-site.

    Within a week from CT perfusion to surgery

Secondary Outcomes (10)

  • Arterial Liver Perfusion (ALP) According to Degree of Lesions Differentiation

    Within a week from CT perfusion to surgery

  • Portal Venous Liver Perfusion (PVP) According to Degree of Lesions Differentiation

    Within a week from CT perfusion to surgery

  • Total Liver Perfusion (TLP) According to Degree of Lesions Differentiation

    Within a week from CT perfusion to surgery

  • Hepatic Perfusion Index (HPI) According to Degree of Lesions Differentiation

    Within a week from CT perfusion to surgery

  • Blood Volume According to Immunohistochemistry Parameter (Glutamine Synthetase)

    Within a week from CT perfusion to surgery

  • +5 more secondary outcomes

Study Arms (1)

CT perfusion

EXPERIMENTAL

arm with CT perfusion

Drug: Xenetix-CT perfusion imaging

Interventions

Xenetix-CT perfusion imagingDRUG

Injection of 50 ml of Xenetix

CT perfusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects diagnosed for HCC and planned for surgery (lobectomy or transplantation) within a timeframe of 30 days between first imaging procedure used for the study and surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

AKH

Vienna, Austria

Location

Universitätsklinikum Erlangen

Erlangen, Germany

Location

SMC

Seoul, South Korea

Location

SNUH

Seoul, South Korea

Location

Zurich University Hospital

Zurich, Switzerland

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Corinne Dubourdieu, PharmD, Head of Clinical Projects and Medical Writing
Organization
Guerbet
corinne.dubourdieu@guerbet-group.com
+33 (0) 1 45 91 50 00

Study Officials

  • Hatem Alkadhi

    Zurich University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2012

First Posted

July 13, 2012

Study Start

April 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

July 13, 2017

Results First Posted

July 13, 2017

Record last verified: 2017-07

Locations

KR(2)AU(1)DE(1)CH(1)