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JOURNAL ONKOLOGIE – STUDIE
HepCaSt

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

Rekrutierend

NCT-Nummer:
NCT05202015

Studienbeginn:
Januar 2022

Letztes Update:
21.01.2022

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

Indikation (Clinical Trials):
Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Charite University, Berlin, Germany

Collaborator:
Bayer

Studienlocations
(1 von 1)

Charité - University Medicine Berlin
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Timo Alexander Auer, M.D.
Phone: +4930450657078
E-Mail: timo-alexander.auer@charite.de

Dominik Geisel, PD M.D.
Phone: +4930450657319
E-Mail: dominik.geisel@charite.de
» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Hepatocellular carcinomas (HCCs) are a heterogeneous group of tumor subtypes with a different

response behavior and prognosis. As a reaction, the World Health Organization (WHO) in its

5th version (updated in 2019) classifies no more two but eight subtypes, each with a

different tumor biology and outcome. The new classification may serve as a key factor

optimizing a more personalized therapeutic approach and therefore, especially diagnostic

disciplines have to implement these new subtypes as soon as possible into their daily

clinical routine algorithms.

Imaging does play a key role in this situation. Newer and advanced MRI techniques allow a

precise tissue characterization. Furthermore, with the help of latest generation

hepatobiliary contrast agents like the usage of Gd-EOB (Primovist) it is possible to quantify

and measure the organ function and specific uptake behavior of focal liver lesions. Another

approach that hold promise for advancing the characterization of HCCs heterogeneity is the

use and development of artificial intelligence (AI)-based image postprocessing algorithms

including radiomics analysis.

To date there aren't any established imaging features correlating with any of the new WHO

HCC-subtypes. The goal of our project is to identify imaging biomarkers correlating with the

new HCC-subtypes, helping to classify them noninvasively. As a next step with the help of our

collaborators we will facilitate a radiological-pathological reference database. In a third

step and with the help of the data we curated we will try to identify morphologic imaging

characteristics by the use of AI-based post-processing algorithms to classify the subtypes

noninvasively and to predict / estimate patients individual therapy response and prognosis.

The last challenge will be to implement these algorithms into daily clinical routine, we

therefore have to identify interface dilemmas and present smart solutions to solve them.

We are convinced that by implementing the updated WHO-criteria into clinical workflows

current believes and guidelines in the diagnosis and therapy of HCC will change. MRI HCC

imaging with Primovist will play a key role in this project. The results of our project may

provide the knowledge to represent as a cornerstone in imaging and therapy assessment of HCC

to improve a personalized therapy approach.

Ein-/Ausschlusskriterien

Inclusion Criteria:

Patients with hisopathologically confirmed HCC and MRI in domo with the standard high-end

MRI Primovist study protocol.

Exclusion Criteria:

Unmet inclusion criteria. MRI contraindications. Patients declines.

Studien-Rationale

Primary outcome:

1. HCC subtype (WHO 5) (Time Frame - Jan 2022 - Jul 2024):
Positive identification of imaging parameters / Imaging Biomarkers correlating with one of the HCC-subtypes.

Geprüfte Regime

  • MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA):
    MRI of the liver accoring to our institutional daily routine protocol

Quelle: ClinicalTrials.gov


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