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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03754192
Other study ID # APHP180011
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 30, 2019
Est. completion date December 30, 2020

Study information

Verified date August 2020
Source Assistance Publique - Hôpitaux de Paris
Contact LEWIN MAITE, MD, Phd
Phone 00 (33) 6 11 15 06 17
Email maite.lewin@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Dual-energy computer tomography and perfusion computer tomography (General Electric revolution Hight definition Gemstoneā„¢ 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Radiation:
perfusion Computed Tomography
Will be carried before liver surgery

Locations

Country Name City State
France CHU Paul Brousse Villejuif

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pefusion parameters correlation between pre-operative imaging data and histological data of Hepatocellular carcinoma 5 minutes
Secondary Pathological examination Compare data obtained in perfusion computer tomography to the imaging data and to the Histological differentiation grades 1 month
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