Hepatic Small Vessel NeoplasmIMAHEPNCT06067035
Hepatic Small Vessel Neoplasm
An observational study of Hepatic Small Vessel Neoplasm, run by Assistance Publique - Hôpitaux de Paris.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatic Small Vessel Neoplasm
- What is being tested?
- Imaging
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with small-vessel liver tumours
Who may be able to join
- 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)
Who cannot join
- Patient under guardianship or curators
Trial locations and contacts
No sites are listed yet.
VALERIE VILGRAIN, MD,PHD contact
About this study
Official title: Imaging of Small-vessel Liver Tumours
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.
Read the 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.
- Conditions
- Hepatic Small Vessel Neoplasm
- Being tested
- Imaging
- Keywords
- Vascular tumors, Hepatic imaging, Neoplasm
- Medical subject headings
- Vascular Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagingOther
Also called surgical specimen
Imaging data from patients with small-vessel liver tumours will be compared with histological data.
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging findings
Aspect on US Ultrasound Scan (US)
Measured: 12 months
Secondary outcomes (2)
Pathological examination
tumors
Measured: 12 months
Biology
bilirubin and alkaline phosphatase rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Small Vessel NeoplasmStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MAITE LEWIN, MD, PHD, Study director, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067035
- Sponsor's protocol ID
- APHP220863
- Acronym
- IMAHEP
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Small-vessel Liver Tumours
- ClinicalTrials.gov ID
- NCT06067035
- Acronym / sponsor ID
- IMAHEP / APHP220863
- Conditions
- Hepatic Small Vessel Neoplasm
- Keywords
- Vascular tumors, Hepatic imaging, Neoplasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with small-vessel liver tumours
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Patient under guardianship or curators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImagingAlso: surgical specimenImaging data from patients with small-vessel liver tumours will be compared with histological data. | Other | – |
Primary outcome
Imaging findings
Time frame: 12 months
Aspect on US Ultrasound Scan (US)
2 secondary outcomes
Pathological examination
Time frame: 12 months
Biology
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VALERIE VILGRAIN, MD,PHD contact
MAITE LEWIN, MD, PHD study director
APHP
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Small Vessel Neoplasm, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MAITE LEWIN, MD, PHD (0611150617, maite.lewin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging findings (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.