NCT05202015

Brief Summary

Non-invasive MRI subclassification of Heptocellular Carcinoma - HepCaSt-Study

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

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

Study Start

First participant enrolled

January 1, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

January 8, 2022

Last Update Submit

January 8, 2022

Conditions

HCCHepatocellular CarcinomaMRI

Outcome Measures

Primary Outcomes (1)

  • HCC subtype (WHO 5)

    Positive identification of imaging parameters / Imaging Biomarkers correlating with one of the HCC-subtypes.

    Jan 2022 - Jul 2024

Interventions

MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA)DRUG

MRI of the liver accoring to our institutional daily routine protocol

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with a suspected HCC undergoing MRT with a hepatobiliary contrast agent (Gd-EOB-DPTA)

You may qualify if:

  • Patients with hisopathologically confirmed HCC and MRI in domo with the standard high-end MRI Primovist study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - University Medicine Berlin

Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Timo Alexander Auer

Study Record Dates

First Submitted

January 8, 2022

First Posted

January 21, 2022

Study Start

January 1, 2022

Primary Completion

January 1, 2024

Study Completion

July 1, 2024

Last Updated

January 21, 2022

Record last verified: 2022-01

Locations

DE(1)