Intra-individual comparison of Gd-EOB-DTPA disodium (Primovist) and Gadobutrol (Gadovist) in patients with suspicion of hepatocellular carcinoma - Primovist® in HCC

Phase 1

• Conditions: Patients of both genders are eligible for this study in case they present with suspicion of HCC after Gadovist® -enhanced MRI.; MedDRA version: 12.0Level: LLTClassification code 10036706Term: Primary liver cancer non-resectable; MedDRA version: 12.0Level: LLTClassification code 10036707Term: Primary liver cancer recurrent; MedDRA version: 12.0Level: LLTClassification code 10036708Term: Primary liver cancer resectable

• Registration Number: EUCTR2009-011095-30-DE
• Lead Sponsor: Medizinische Fakultät Mannheim, Ruprecht-Karls-Universität Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-03
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1.Liver lesion, suspicion of hepatocellular carcinoma
2.Having received Gadovist®-enhanced MRI of the liver for clinical reasons
3.Age: 18-80 years
4.Willing to comply with the study procedures
5.Patients who have given their fully informed and written consent voluntarily

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.If female, of childbearing potential
2.GFR <50 mL/min/1.73m² (MDRD or Cockroft-Gault formula), values =4 weeks
3.Not being able to remain lying down for at least 45-60 min (e.g., patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain)
4.Known allergy to any ingredient of Primovist®
5.Any contraindication for Primovist® (according to SmPC)
6.Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents
7.Being clinically unstable
8.Having any contraindication to MRI examination (e.g., pacemaker, recent wound clips, and severe claustrophobia).
9.Having any physical or mental status that interferes with the informed consent procedure including self-signed consent
10.Close affiliation with the investigational site; e.g. a close relative of the investigator
11.Having been previously enrolled in this study
12.Participating in another clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to prove the non-inferiority of Primovist® vs. Gadovist® for detection of HCC using a truth panel assessment as the SOR;Secondary Objective: •to assess the total number of liver lesions (Gadovist® vs. Primovist®)<br>•to assess the confidence in diagnosis (Gadovist® vs. Primovist®)<br>•to assess SNR and CNR of liver lesions (Gadovist® vs. Primovist®)<br>;Primary end point(s): Sensitivity for detection of HCC taking a truth panel assessment as the standard of reference (on the basis of liver segments)