Validation of SMS Protocol for HCC Screening in High-risk Patients

Erasmus University

Status: Invitation-only

Conditions: Hepatocellular Carcinoma

Treatments: Radiation: Short MRI surveillance (SMS) protocol; Radiation: Bi-annual ultrasonography screening

Study type: Observational

Funder types: Other

Identifiers

NCT05429190

2021-2 / 13803

Details and patient eligibility

About

The investigators will assess implementation of the proposed SMS protocol as a surveillance tool in patients at high risk of developing HCC in a prospective multicenter study.

Full description

Over the past 20 years, the prevalence of HCC has been growing extensively. HCC makes up for 75-85% of primary liver cancers and has a poor prognosis with a 5-year survival rate lower than 20%. The incidence of HCC is higher in patients diagnosed with hepatitis and/or cirrhosis. The current guidelines recommend a bi-annual US screening of this patient group. However, recent meta-analysis showed that the sensitivity of such US surveillance for detecting early stage HCC is merely 47%. In addition, early detection of small HCC lesions (with a diameter less than 2 cm) will provide a higher survival chance. It is therefore of major importance to develop a better surveillance tool.

The use of MRI should be considered as a surveillance tool for this patient group. In comparison to US, MRI come with high cost, long duration of the scan, limited availability and a potential risk related to the use of contrast agents. The investigators have developed and validated a short MRI surveillance (SMS) protocol for HCC screening in high-risk patients. This protocol has been evaluated among a database of 215 patients. In this prospective, multicenter study, the investigators will evaluate the value of the SMS protocol in a high-risk patient group and they will assess the cost-effectiveness of the SMS protocol as a surveillance tool with respect to a bi-annual US screening.

Enrollment: 470 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients above 18 years of age
• High-risk patients with cirrhosis and/or hepatitis

Exclusion criteria

• Patients below the age of 18 years
• Patients who will not sign the informed consent form
• Patients with general contra-indications for undergoing MRI examination