Primovist CT: proof of concept

Primovist CT: proof of concept - CT Primovist

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003812-30-NL

Enrollment

Registered

2020-04-15

Start date

2020-10-21

Completion date

Unknown

Last updated

2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular adenoma

Interventions

Trade Name: Primovist PFS 0,25 mmol/ml, oplossing voor injectie, voorgevulde spuit Product Name: Primovist Pharmaceutical Form: Solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - MRI with Primovist before CT scan - Diagnosis of minimally one FNH (5 patients) and one HCA (5 patients) - Lesion must be at least 3 cm - Age of 18 years or older Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - No contraindication for CT (pregnancy)

Design outcomes

Primary

Measure	Time frame
Main Objective: To analyse if dual energy CT can be used for analysis of Primovist uptake in liver lesions like FNHs and adenomas. Primary objective: Difference in density of the liver compared to virtual non contrast CT;Secondary Objective: Measurable difference in density between liver and hepatocellular adenoma and FNHs;Primary end point(s): Significant difference in density of the liver compared to the virtual non-contrast images of the liver. This will be measured quantitatively, based on a minimal enhancement of 20 Hounsfield Units. Significant difference in density of the FNHs/adenomas compared to the surrounding liver, both quantitatively as qualitatively. Quantitative difference has to be minimally 20 Hounsfield Units. Qualitative evaluation will be performed by 2 experienced radiologists, without knowing location and final diagnosis from MRI or each others interpretation. The evaluation by the radiologists will be performed on a standard workstation with application of Siemens (Syngovia).;Timepoint(s) of evaluation of this end point: After the last included patient scan is performed.	—

Measure

Time frame

Main Objective: To analyse if dual energy CT can be used for analysis of Primovist uptake in liver lesions like FNHs and adenomas. Primary objective: Difference in density of the liver compared to virtual non contrast CT;Secondary Objective: Measurable difference in density between liver and hepatocellular adenoma and FNHs;Primary end point(s): Significant difference in density of the liver compared to the virtual non-contrast images of the liver. This will be measured quantitatively, based on a minimal enhancement of 20 Hounsfield Units. Significant difference in density of the FNHs/adenomas compared to the surrounding liver, both quantitatively as qualitatively. Quantitative difference has to be minimally 20 Hounsfield Units. Qualitative evaluation will be performed by 2 experienced radiologists, without knowing location and final diagnosis from MRI or each others interpretation. The evaluation by the radiologists will be performed on a standard workstation with application of Siemens (Syngovia).;Timepoint(s) of evaluation of this end point: After the last included patient scan is performed.

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Secondary

Measure	Time frame
Secondary end point(s): Minimal dose needed for accurate differentiation based on difference of minimally 20 Hounsfield Units.;Timepoint(s) of evaluation of this end point: After the last included patient scan is performed.	—

Countries

Netherlands

Contacts

Public ContactTrial Assistant

Erasmus MC

imaging.trialbureau@erasmusmc.nl+310107033612

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026