NCT06067035

Brief Summary

Small-vessel hepatic tumor is a new tumor entity of vascular origin, described in 2016 by Gill et al, in a series of 17 patients. This rare lesion is difficult to diagnose on imaging because it shares a common radiological semiology with several other differential diagnoses ranging from benign hepatic angioma to more aggressive lesions such as angiosarcoma.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2023

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

September 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

October 4, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

September 22, 2023

Last Update Submit

October 2, 2023

Conditions

Hepatic Small Vessel Neoplasm

Keywords

Vascular tumorsHepatic imagingNeoplasm

Outcome Measures

Primary Outcomes (1)

  • Imaging findings

    Aspect on US Ultrasound Scan (US)

    12 months

Secondary Outcomes (2)

  • Pathological examination

    12 months

  • Biology

    12 months

Interventions

ImagingOTHER

Imaging data from patients with small-vessel liver tumours will be compared with histological data.

Also known as: surgical specimen

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with small-vessel liver tumours

You may qualify if:

  • Histological evidence of a small vessel hepatic tumor either on biopsy or surgical specimen
  • Cross-sectional imaging before the biopsy or pre-operatively (CT, MRI)

You may not qualify if:

  • Patient under guardianship or curators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vascular NeoplasmsNeoplasms

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Soft Tissue NeoplasmsNeoplasms by SiteVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • MAITE LEWIN, MD, PHD

    APHP

    STUDY DIRECTOR

Central Study Contacts

MAITE LEWIN, MD, PHD

CONTACT

0611150617maite.lewin@aphp.fr

VALERIE VILGRAIN, MD,PHD

CONTACT

valerie.vilgrain@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2023

First Posted

October 4, 2023

Study Start

October 1, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

October 4, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share