Perfusion and Dual Energy Computer Tomography in Hepatoce... | NCT03754192

Studies
Perfusion and Dual Energy Computer Tomography in Hepatocellular Carcinoma

NCT03754192

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Sep 1, 2020Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Hepatocellular Carcinoma

Interventions

perfusion Computed Tomography

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2019Actual

Primary Completion Date

Dec 30, 2020Estimated

Completion Date

Dec 30, 2020Estimated

First Submitted Date

Nov 14, 2018

First Submission Date that Met QC Criteria

Nov 26, 2018

First Posted Date

Nov 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2020

Last Update Posted Date

Sep 1, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to evaluate the hepatic perfusion computer tomography and dual energy computer tomography in the assessment of tumor characterization of Hepatocellular carcinoma in patients with resectable Hepatocellular carcinoma by comparing the quantitative parameters computer tomography obtained with the pathological data of the surgical specimens.

Detailed Description

Dual-energy computer tomography and perfusion computer tomography (General Electric revolution Hight definition Gemstone™ Spectral Imaging) will be performed in all patients. Iodine concentration and quantitative perfusion parameters of the Hepatocellular carcinoma and surrounding liver parenchyma data will be compared with the pathological results.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
perfusion computed tomography	Other	Will be realsed before liver surgery	Radiation: perfusion Computed Tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
perfusion Computed Tomography	Radiation	Will be carried before liver surgery	perfusion computed tomography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pefusion parameters	correlation between pre-operative imaging data and histological data of Hepatocellular carcinoma	5 minutes

Secondary Outcomes

Measure	Description	Time Frame
Pathological examination	Compare data obtained in perfusion computer tomography to the imaging data and to the Histological differentiation grades	1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A diagnosis of Hepatocellular carcinoma made according to the guidelines of the American Association for the study of the Liver
Affiliation to a national health insurance
An indication for hepatic resection during the decision-making stage
A request for a pre-operative Computer Tomography in our radiology unit
An affiliation to a social security
Informed consent given by the patient

Exclusion Criteria:

Previous treatments of Hepatocellular carcinoma (medicated or surgical)
Patient under tutorship or curatorship
Pregnant or lactating woman

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
LEWIN MAITE, MD, Phd	Contact	00 (33) 6 11 15 06 17		maite.lewin@aphp.fr
DA-MOTA-FERREIRA Jean-Manuel, Radiologic	Contact	00 (33) 145592474		jean-manuel.da-mota-ferreira@aphp.fr

Overall Officials

Name	Affiliation	Role
LEWIN MAITE, MD, PhD	APHP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Paul Brousse	Recruiting	Villejuif		94800	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35419748	Derived	Lewin M, Laurent-Bellue A, Desterke C, Radu A, Feghali JA, Farah J, Agostini H, Nault JC, Vibert E, Guettier C. Evaluation of perfusion CT and dual-energy CT for predicting microvascular invasion of hepatocellular carcinoma. Abdom Radiol (NY). 2022 Jun;47(6):2115-2127. doi: 10.1007/s00261-022-03511-7. Epub 2022 Apr 13.

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

ID	Term
D003597	Cytosine Nucleotides
D011742	Pyrimidine Nucleotides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring