To analyze the percentage of HCA becoming hypointens 20-25-30-35-40-45 minutes after IV contrast injection of gadobenate dimeglumine.
ID
Source
Brief title
Condition
- Hepatic and biliary neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Quantitative assessment: only lesions larger than 1 cm will be included
(measurements in smaller lesions are less accurate). A ROI will be placed in
each lesions and in the neighboring liver. Measurement will be performed at
every time point including the late hepatobiliary phase.
- Qualitative assessment: all visible lesions will be included. Two readers
will independently choose the turning time point where a lesion becomes
hypointense to the surrounding liver. A consensus reading will be performed and
interreader agreement will be evaluated.
- The percentage of lesions that become hypointense to the liver measured every
2.5 minutes during 45 minutes will be extrapolated with 95 % confidence
intervals
Secondary outcome
- The effect of changing flip angle on the T1-weighting will be studied
Background summary
Rationale: Optimal delay time for hepatobiliairy imaging with MRI of gadobenate
dimeglumine is not known
Objective: to analyse the optimal delay time for gadobenate dimeglumine
Study design: prospective one center observational study
Study population: patients who undergo MRI with gadobenate dimeglumine
Intervention (if applicable): observational study The patients will have to
stay +/- 15 minutes longer after contrast injection in the MRI room (45 minutes
instead of 25-30 minutes).
Main study parameters/endpoints: The percentage of hepatocellular adenomas
that become hypointense to the liver at several time points
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: no intervention will take place. There will be
no additional risks, burden or benefit for the patient.
Study objective
To analyze the percentage of HCA becoming hypointens 20-25-30-35-40-45 minutes
after IV contrast injection of gadobenate dimeglumine.
Study design
- Prospective randomized cohort study
- Unicentric
- We expect final start date in February 2016. 17 patients will probably be
scanned by july 2016, the second third by March 2016 and the final inclusion
by October 2017.We expect that around 11 patients will be excluded since this
number is expected to be finally FNHs based on the Multihance scan. If the
results are promising, acquisition of additional patients will be considered in
consultation with BRACCO.
Study burden and risks
There are no benefits or risks.
s'Gravendijkwal 230
Rotterdam 3015 CE
NL
s'Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- capacity to read and interpret informed consent
- clinical indication for MRI with gadobenate dimeglumine, including delayed phase imaging after one hour
Exclusion criteria
- contraindication for MRI
- contraindication for gadobenate dimeglumine
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 | NL49672.078.14 |