Hepatocellular CarcinomaPhase 4NCT01639703

Hepatic Xenetix-CT Perfusion

A Phase 4 study testing Xenetix-CT perfusion imaging in people with Hepatocellular Carcinoma, run by Guerbet at 5 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatocellular Carcinoma
What is being tested?: Xenetix-CT perfusion imaging
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 5 sitesin 4 countries
Study dates: Apr 2012to Oct 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Subjects who have undergone prior TACE (TransArterial Chemo Embolization), prior RFA (Radio Frequency Ablation) or prior SIRT (Selected Internal Radio Therapy) within one year before inclusion.

Trial locations and contacts

5 sites in 4 countries.

Country

City, postcode or hospital

5 sites in 4 countries

South Korea2 sites

SMC
Seoul
SNUH
Seoul

Other trials in South Korea

Austria1 site

AKH
Vienna

Other trials in Austria

Germany1 site

Universitätsklinikum Erlangen
Erlangen

Other trials in Germany

Switzerland1 site

Zurich University Hospital
Zurich

Other trials in Switzerland

About this study

Official title: Diagnostic Contribution of XENETIX® CT PERFUSION in Pre-therapeutical Assessment of Hepatocellular Carcinoma

Conditions: Hepatocellular Carcinoma
Being tested: Xenetix-CT perfusion imaging
Keywords: CT perfusion, Hepatocellular Carcinoma, Xenetix, Contrast agent
Medical subject headings: Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Xenetix-CT perfusion imagingDrug
Injection of 50 ml of Xenetix

Study groups in NCT01639703
Study group	Role	What they receive
CT perfusion	Experimental	arm with CT perfusion Receives: Drug: Xenetix-CT perfusion imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Within a week from CT perfusion to surgery

Secondary outcomes (10)

Arterial Liver Perfusion (ALP) 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.
Measured: Within a week from CT perfusion to surgery
Portal Venous Liver Perfusion (PVP) 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.
Measured: Within a week from CT perfusion to surgery
Total Liver Perfusion (TLP) 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.
TLP = ALP + PVP
Measured: Within a week from CT perfusion to surgery
Hepatic Perfusion Index (HPI) 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.
Measured: Within a week from CT perfusion to surgery
Blood Volume According to Immunohistochemistry Parameter (Glutamine Synthetase)
Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.
Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the "glutamine synthetase 0%" category.
Measured: Within a week from CT perfusion to surgery
Blood Volume According to Immunohistochemistry Parameter (CD31)
CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the "CD31 0%" category.
Measured: Within a week from CT perfusion to surgery
Blood Flow According to Immunohistochemistry Parameter (Glutamine Synthetase)
Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.
Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the "glutamine synthetase 0%" category.
Measured: Within a week from CT perfusion to surgery
Blood Flow According to Immunohistochemistry Parameter (CD31)
CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the "CD31 0%" category.
Measured: Within a week from CT perfusion to surgery
Permeability Surface According to Immunohistochemistry Parameter (Glutamine Synthetase)
Glutamine synthetase is an immunohistochemistry parameter of hepatocellular carcinoma phenotype.
Glutamine synthetase labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of glutamine synthetase labelling, lesions were classified in the "glutamine synthetase 0%" category.
Measured: Within a week from CT perfusion to surgery
Permeability Surface According to Immunohistochemistry Parameter (CD31)
CD31 is an immunohistochemistry marker of microvessel density. CD31 labelling was quantified and in case of positive quantification, classified in the following categories: 1-10%, 10-50% and >50%. In case of absence of CD31 labelling, lesions were classified in the "CD31 0%" category.
Measured: Within a week from CT perfusion to surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Oct 2014

First posted13 Jul 2012 (estimated)
Study startApr 2012
Primary completionOct 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01639703
Sponsor's protocol ID: ISO-44-013
Status last verified: Jul 2017
First submitted: 6 Jul 2012
Last updated: 13 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
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Enrolling by invitationPhase 3
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Active, not recruiting
BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma Non-resectable
Active, not recruitingPhase 1
Nivolumab With or Without Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma
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All Hepatocellular Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Diagnostic Contribution of XENETIX® CT PERFUSION in Pre-therapeutical Assessment of Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT01639703
Acronym / sponsor ID: ISO-44-013
Conditions: Hepatocellular Carcinoma
Keywords: CT perfusion, Hepatocellular Carcinoma, Xenetix, Contrast agent
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: GuerbetIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 13 Jul 2012 (estimated)
Results: Posted 13 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CT perfusion	Experimental	Drug: Xenetix-CT perfusion imagingarm with CT perfusion

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

Subjects who have undergone prior TACE (TransArterial Chemo Embolization), prior RFA (Radio Frequency Ablation) or prior SIRT (Selected Internal Radio Therapy) within one year before inclusion.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Xenetix-CT perfusion imagingInjection of 50 ml of Xenetix	Drug	CT perfusion

Primary outcome

Blood Volume (BV) According to Degree of Lesions Differentiation
Time frame: Within a week from CT perfusion to surgery
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.
Blood Flow (BF) According to Degree of Lesions Differentiation
Time frame: Within a week from CT perfusion to surgery
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.
Permeability Surface (PS) According to Degree of Lesions Differentiation
Time frame: Within a week from CT perfusion to surgery
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.

10 secondary outcomes

Arterial Liver Perfusion (ALP) According to Degree of Lesions Differentiation
Time frame: Within a week from CT perfusion to surgery
Portal Venous Liver Perfusion (PVP) According to Degree of Lesions Differentiation
Time frame: Within a week from CT perfusion to surgery
Total Liver Perfusion (TLP) According to Degree of Lesions Differentiation
Time frame: Within a week from CT perfusion to surgery
Hepatic Perfusion Index (HPI) According to Degree of Lesions Differentiation
Time frame: Within a week from CT perfusion to surgery
Blood Volume According to Immunohistochemistry Parameter (Glutamine Synthetase)
Time frame: Within a week from CT perfusion to surgery
Blood Volume According to Immunohistochemistry Parameter (CD31)
Time frame: Within a week from CT perfusion to surgery
Blood Flow According to Immunohistochemistry Parameter (Glutamine Synthetase)
Time frame: Within a week from CT perfusion to surgery
Blood Flow According to Immunohistochemistry Parameter (CD31)
Time frame: Within a week from CT perfusion to surgery
Permeability Surface According to Immunohistochemistry Parameter (Glutamine Synthetase)
Time frame: Within a week from CT perfusion to surgery
Permeability Surface According to Immunohistochemistry Parameter (CD31)
Time frame: Within a week from CT perfusion to surgery

Results and safety

Results posted to the registry on 13 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CT Perfusion	96	84

Primary outcome: Blood Volume (BV) According to Degree of Lesions Differentiation

Time frame: Within a week from CT perfusion to surgery. Mean (Standard Deviation). Unit: mL/100 grams

Measure	Well Differentiated Lesions n = 38	Moderately/Poorly Differentiated Lesions n = 42
Value	15.930 (6.663)	13.958 (5.315)

Population analysed: A total of 77 patients were analyzed for CT perfusion parameters: 38 had lesions assessed as "well differentiated", 42 had lesions assessed as "moderately/poorly differentiated" and 3 had lesions assessed as "well differentiated" and "moderately/poorly differentiated".

Primary outcome: Blood Flow (BF) According to Degree of Lesions Differentiation

Time frame: Within a week from CT perfusion to surgery. Mean (Standard Deviation). Unit: mL/100 grams/min

Measure	Well Differentiated Lesions n = 38	Moderately/Poorly Differentiated Lesions n = 42
Value	73.042 (21.551)	72.051 (31.792)

Primary outcome: Permeability Surface (PS) According to Degree of Lesions Differentiation

Time frame: Within a week from CT perfusion to surgery. Mean (Standard Deviation). Unit: mL/100 grams/min

Measure	Well Differentiated Lesions n = 38	Moderately/Poorly Differentiated Lesions n = 42
Value	26.421 (10.014)	27.750 (9.425)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded during and immediately after the CT perfusion examination over a 30 min follow up period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Set	0 of 84 (0%)	4 of 84 (4.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatocellular Carcinoma

Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
RecruitingObservational study
Observational Study Protocol: LIVER-R
Hepatobiliary Cancers
Enrolling by invitationPhase 3
Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study
Cancer, Renal Cell Carcinoma (RCC)
Active, not recruiting
BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma Non-resectable
Active, not recruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hatem Alkadhi principal investigator

Zurich University Hospital

5 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Xenetix-CT perfusion imaging in people with Hepatocellular Carcinoma, run by Guerbet at 5 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in South Korea, Austria, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Volume (BV) According to Degree of Lesions Differentiation (time frame: Within a week from CT perfusion to surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01639703.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.