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Perfusion and Dual Energy Computer Tomography in Hepatocellular Carcinoma (PERCAHEC)

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
perfusion Computed Tomography
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring Perfusion computer tomography, dual-energy computer tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Paul BrousseRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

perfusion computed tomography

Arm Description

Will be realsed before liver surgery

Outcomes

Primary Outcome Measures

Pefusion parameters
correlation between pre-operative imaging data and histological data of Hepatocellular carcinoma

Secondary Outcome Measures

Pathological examination
Compare data obtained in perfusion computer tomography to the imaging data and to the Histological differentiation grades

Full Information

First Posted
November 14, 2018
Last Updated
August 31, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03754192
Brief Title
Perfusion and Dual Energy Computer Tomography in Hepatocellular Carcinoma
Acronym
PERCAHEC
Official Title
Prediction Value of Perfusion and Dual Energy Computer Tomography for Microvascular Invasion in Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 30, 2019 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Perfusion computer tomography, dual-energy computer tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Dual-energy computed tomography and perfusion computed tomography
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
perfusion computed tomography
Arm Type
Other
Arm Description
Will be realsed before liver surgery
Intervention Type
Radiation
Intervention Name(s)
perfusion Computed Tomography
Other Intervention Name(s)
Computed tomography
Intervention Description
Will be carried before liver surgery
Primary Outcome Measure Information:
Title
Pefusion parameters
Description
correlation between pre-operative imaging data and histological data of Hepatocellular carcinoma
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Pathological examination
Description
Compare data obtained in perfusion computer tomography to the imaging data and to the Histological differentiation grades
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LEWIN MAITE, MD, Phd
Phone
00 (33) 6 11 15 06 17
Email
maite.lewin@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
DA-MOTA-FERREIRA Jean-Manuel, Radiologic
Phone
00 (33) 145592474
Email
jean-manuel.da-mota-ferreira@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LEWIN MAITE, MD, PhD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Paul Brousse
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LEWIN MAITE, MD, PhD
Phone
00 (33) 6 11 15 06 17
Email
maite.lewin@aphp.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
35419748
Citation
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.
Results Reference
derived

Learn more about this trial

Perfusion and Dual Energy Computer Tomography in Hepatocellular Carcinoma

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