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

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Recruiting
CT.gov ID
NCT05202015
Collaborator
Bayer (Industry)
150
1
30
5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA)

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Non-invasive MRI Subclassification of Heptocellular Carcinoma - HepCaSt-Study
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Outcome Measures

Primary Outcome Measures

  1. HCC subtype (WHO 5) [Jan 2022 - Jul 2024]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charité - University Medicine Berlin Berlin Germany 13353

Sponsors and Collaborators

  • Charite University, Berlin, Germany
  • Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Timo A. Auer, Dr. med. Timo Alexander Auer, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT05202015
Other Study ID Numbers:
  • EA1/323/20
First Posted:
Jan 21, 2022
Last Update Posted:
Jan 21, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 21, 2022