Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT05276037

Value of Negative 18FDG PET/CT in Milan Out, Up-to-seven in, HCC Transplant Candidates

Led by University of Liege · Updated on 2022-09-01

350

Participants Needed

6

Research Sites

521 weeks

Total Duration

On this page

Sponsors

U

University of Liege

Lead Sponsor

U

University Hospital, Ghent

Collaborating Sponsor

AI-Summary

What this Trial Is About

Hepatocellular carcinoma (HCC) is a rising public health concern with few curative options but liver transplantion (LT) in highly selected cases. LT could save many other HCC patients but organ shortage has lead to the necessity of selection of patients with the best survival chances, namely the Milan criteria. Hepatocellular carcinoma (HCC) is the fifth most common cancer, and the third cause of cancer related-death worldwide. HCC incidence is rising in Western countries including Belgium. There are more than 1,000 new HCC diagnoses in Belgium every year, but only 90 to 100 patients suffering from HCC are listed for liver transplantation (LT). In fact, the scarcity of organ donors has forced the development of strict criteria to limit LT to patients who are likely to have excellent outcomes. The universally accepted LT criteria for HCC are the Milan criteria (1 HCC nodule ≤5 cm or 3 nodules ≤3cm) that lead to a low rate of post-LT recurrence (\>80% of disease free recurrence at 5 years). The majority of patients suffering from HCC outside the Milan criteria at the time of diagnosis is not eligible for LT and is therefore limited to palliative care. It is however considered that some of these patients with HCC outside the Milan criteria may benefit from LT with an acceptable risk of recurrence and chances of long-term disease-free survival (DFS). This fact has led to the extension of LT criteria for HCC in some centres in different countries, as for example the University of California San Francisco (UCSF) criteria, the up-to-seven criteria or the Asan criteria. The Belgian Liver-Intestine Allocation Committee (Be-LIAC) is a section of the Belgian Transplantation Society (BTS) composed of the 6 LT Belgian centres in charge of coordinating deceased LT activity in Belgium with the help of Eurotransplant. Be-LIAC has already built a retrospective HCC database that was successfully used for several scientific studies allowing international presentations and publications. Based on this successful experience, Be-LIAC is keen to continue with this national collaboration to initiate a prospective clinical observational database to better study the results of LT in Belgium and to evaluate potential of extension of LT criteria in HCC patients. Inclusion in this database will not change patient management or the allocation process of the liver grafts in Belgium. This project is financed by a 4-year (2019-2022) grant of the Belgian "Fondation contre le cancer" / "Stichting tegen Kanker".

CONDITIONS

Official Title

Value of Negative 18FDG PET/CT in Milan Out, Up-to-seven in, HCC Transplant Candidates

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Hepatocellular carcinoma diagnosis
  • Candidate for liver transplantation after multidisciplinary discussion
Not Eligible

You will not qualify if you...

  • Age younger than 18 years or older than 80 years
  • Medical conditions contraindicating liver transplantation such as other cancers, psychiatric disease, uncontrolled infection, lack of compliance, active alcohol abuse, cardiac, pulmonary, surgical, or other medical contraindications
  • Hepatocellular carcinoma with extra-hepatic metastases, lymphatic involvement, or macroscopic vascular invasion

AI-Screening

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Trial Site Locations

Total: 6 locations

1

University Hospital, Antwerp

Antwerp, Belgium

Actively Recruiting

2

Free University of Brussels

Brussels, Belgium

Actively Recruiting

3

University Hospital, Ghent

Ghent, Belgium

Actively Recruiting

4

Catholic University of Louvain

Leuven, Belgium

Actively Recruiting

5

Leuven University hospital

Leuven, Belgium

Actively Recruiting

6

ULiège

Liège, Belgium

Actively Recruiting

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Research Team

O

Olivier Detry, MD PhD

CONTACT

C

Céline Lambrecht

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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