Hepatic Small Vessel Neoplasm | NCT06067035

Studies
Hepatic Small Vessel Neoplasm

NCT06067035

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Oct 4, 2023Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Hepatic Small Vessel Neoplasm

Interventions

Imaging

Countries

Not provided

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

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2023Estimated

Primary Completion Date

Nov 1, 2024Estimated

Completion Date

Nov 2024Estimated

First Submitted Date

Sep 22, 2023

First Submission Date that Met QC Criteria

Oct 2, 2023

First Posted Date

Oct 4, 2023Actual

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

Oct 2, 2023

Last Update Posted Date

Oct 4, 2023Actual

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

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.

Detailed Description

The aim of our study is to enable the imaging diagnosis of a new entity: small vessel hepatic tumor in order to improve diagnostic management.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Imaging	Other	Imaging data from patients with small-vessel liver tumours will be compared with histological data.		surgical specimen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Imaging findings	Aspect on US Ultrasound Scan (US)	12 months

Secondary Outcomes

Measure	Description	Time Frame
Pathological examination	tumors	12 months
Biology	bilirubin and alkaline phosphatase rate	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

Patient under guardianship or curators

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with small-vessel liver tumours

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
MAITE LEWIN, MD, PHD	Contact	0611150617		maite.lewin@aphp.fr
VALERIE VILGRAIN, MD,PHD	Contact			valerie.vilgrain@aphp.fr

Overall Officials

Name	Affiliation	Role
MAITE LEWIN, MD, PHD	APHP	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019043	Vascular Neoplasms
D009369	Neoplasms

Ancestor Terms

ID	Term
D012983	Soft Tissue Neoplasms
D009371	Neoplasms by Site
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014965	X-Rays

Ancestor Terms

ID	Term
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided