NCT03754192

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 14, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 30, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

1.9 years

First QC Date

November 14, 2018

Last Update Submit

August 31, 2020

Conditions

Keywords

Perfusion computer tomographydual-energy computer tomography

Outcome Measures

Primary Outcomes (1)

  • Pefusion parameters

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

    5 minutes

Secondary Outcomes (1)

  • Pathological examination

    1 month

Study Arms (1)

perfusion computed tomography

OTHER

Will be realsed before liver surgery

Radiation: perfusion Computed Tomography

Interventions

Will be carried before liver surgery

Also known as: Computed tomography
perfusion computed tomography

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Paul Brousse

Villejuif, 94800, France

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Cytidine Triphosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • LEWIN MAITE, MD, PhD

    APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

LEWIN MAITE, MD, Phd

CONTACT

DA-MOTA-FERREIRA Jean-Manuel, Radiologic

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Dual-energy computed tomography and perfusion computed tomography
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 27, 2018

Study Start

January 30, 2019

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

September 1, 2020

Record last verified: 2020-08

Locations