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

Hepatocellular Carcinoma Clinical Trial

— HepCaSt  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05202015
• Other study ID #: EA1/323/20
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 1, 2024
• Est. primary completion date: January 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• HCC
• Hepatocellular Carcinoma
• MRI

Intervention

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

Locations

Country	Name	City	State
Germany	Charité - University Medicine Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCC subtype (WHO 5)	Positive identification of imaging parameters / Imaging Biomarkers correlating with one of the HCC-subtypes.	Jan 2022 - Jul 2024