Validation of MRI with Primovist® for differentiation of FNH and HCA.Do imaging and histological outcome correlate?Is it possible to use MRI with Primovist® (as gold standard) in the diagnostic work-up of FNH and HCA?
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Hepatic and biliary neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome of imaging studies, especially the MRI will be compared with the
histological outcome.
A pronouncement can be made about the accuracy of MRI with Primovist® for the
differentiation of FNH and HCA.
Secondary outcome
Comparison of histological outcome of the liver biopsy and the resection
specimen
Background summary
Focal nodular hyperplasia (FNH) and hepatocellular adenoma (HCA) are benign
liver tumours, which predominantly occur in young and middle-aged women.
Differentiation between FNH and HCA based on imaging studies remains difficult,
but is important because both tumours require different therapeutic
management1. The natural course of FNH is in most patients asymptomatic and no
cases of malignant transformation are known, therefore conservative management
is justified. In contrast, HCA (especially with a diameter >5cm) is an
indication for surgery because of the risk of malignant transformation and the
risk of spontaneous rupture and haemorrhage2-6. The current gold standard for
diagnosis of these tumours is histological assessment.
Aim of this study is to assess the accuracy of MRI with Primovist® for
differentiation of FNH and HCA. In this end, diagnosis based on MRI imaging
with use of Primovist® is compared to histological outcome (core biopsy and/or
resection preparate).
Study objective
Validation of MRI with Primovist® for differentiation of FNH and HCA.
Do imaging and histological outcome correlate?
Is it possible to use MRI with Primovist® (as gold standard) in the diagnostic
work-up of FNH and HCA?
Study design
Prospective study. Patients referred to our hospital on the suspicion of HCA
and/or FNH > 2cm are included. All patients will undergo a four phase CT scan
and an MRI scan with Primovist®. An ultrasound is performed and guided biopsy
is taken for histological investigation. When resection is performed, the
resected part of the liver is also investigated histologically. The multiphasic
CT scan and MRI scan with Primovist® will be read prospectively and separately
by two abdominal radiologists. Based on known characteristics of the tumors, a
diagnosis will be obtained. Finally the radiological outcome will be compared
with the histological outcome and the role of MRI with Primovist® in the
diagnostic work-up of HCA and FNH will be assessed.
Study burden and risks
In this study a four phase CT scan, an MRI with Primovist® and an ultrasound
with liver core biopsy (16-18 gauche) are performed. Imaging guided biopsy has
greatly improved the diagnostic accuracy of percutaneous liver biopsy, with a
low degree of risk to the patient7. Complications of the liver biopsy include
bleeding (0,03-0,04%8), seeding metastasis in case of malignancy (no
percentages known in this context, but in case of HCC this risk is <2%9).
IWO-1-155 Meibergdreef 9
1105 AZ Amsterdam
NL
IWO-1-155 Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients over 18 years of age referred to our hospital with suspicion of FNH and/or HCA >2cm. Informed consent must be obtained.
Exclusion criteria
Patients under 18 years of age
Patients who are pregnant
Patients with hemorrhage due to a ruptured lesion
Patients who are claustrophobic (MRI scan)
Patients who have magnetic or radiofrequency sensitive implants (MRI scan)
Patients with extreme obesity (MRI scan and US)
Patients with suspicion of a malignant lesion in the liver
Patients with known coagulation disorders
Patients with known systemic allergy for iodinated contrast
Patients with serious renal insufficiency
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL18806.018.07 |