Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Hepatocellular carcinoma diagnosis
- Candidate for liver transplantation after multidisciplinary discussion
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
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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