RecruitingNCT05276037

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

Extension of Liver Transplantation Opportunity to Patients Suffering From Milan-out, Up-to-7-in, Hepatocellular Carcinoma: a Prospective Belgian Study of the Value of Negative 18FDG PET/CT


Sponsor

University of Liege

Enrollment

350 participants

Start Date

Jan 1, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

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".


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether a negative PET/CT scan (which looks for cancer activity throughout the body) can safely identify liver transplant candidates with liver cancer (HCC) who are beyond standard size criteria, but may still do well after transplant. **You may be eligible if...** - You have hepatocellular carcinoma (HCC, primary liver cancer) - You have been approved as a liver transplant candidate by a multidisciplinary team **You may NOT be eligible if...** - You are under 18 or over 80 years old - You have medical conditions unrelated to the liver that prevent transplant (e.g., uncontrolled infection, active alcohol use, heart or lung problems) - Your cancer has spread outside the liver (lymph nodes or distant metastases) - Your cancer has invaded major blood vessels in the liver Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLiver transplantation

Both groups will receive the same advantages on the LT waiting list (SE points)


Locations(6)

University Hospital, Antwerp

Antwerp, Belgium

Free University of Brussels

Brussels, Belgium

University Hospital, Ghent

Ghent, Belgium

Catholic University of Louvain

Leuven, Belgium

Leuven University hospital

Leuven, Belgium

ULiège

Liège, Belgium

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NCT05276037


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