Clinical Trial Results:
Performance of Elucirem (gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) perfusion of brain gliomas
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Summary
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EudraCT number |
2022-002720-12 |
Trial protocol |
HU |
Global end of trial date |
28 Nov 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
31 Oct 2025
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First version publication date |
31 Oct 2025
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GDX-44-016
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT06057168 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Guerbet
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Sponsor organisation address |
15 rue Vanesses, 93420 Villepinte, France,
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Public contact |
Frantz Hebert, Global Head of Clinical Development, Guerbet, +33 680249334, frantz.hebert@guerbet.com
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Scientific contact |
Frantz Hebert, Global Head of Clinical Development, Guerbet, +33 680249334, frantz.hebert@guerbet.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
07 Apr 2025
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Nov 2024
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Nov 2024
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To demonstrate the non-inferiority of DSC-MRI perfusion using Elucirem at 0.05 mmol/kg compared to DSC-MRI perfusion using Dotarem at 0.1 mmol/kg in terms of diagnostic quality of CBV perfusion
map (off-site assessment).
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Protection of trial subjects |
This trial has been conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, that are consistent with Good Clinical Practice (GCP) according to International
Conference on Harmonisation (ICH) guidelines and with the applicable regional/local regulations of the country in which the trial was conducted.
The safety data were monitored during the whole study period.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
07 Sep 2023
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Hungary: 72
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Country: Number of subjects enrolled |
Italy: 47
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Country: Number of subjects enrolled |
Poland: 17
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Worldwide total number of subjects |
136
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EEA total number of subjects |
136
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
102
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From 65 to 84 years |
34
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 141 patients were screened in 10 centers from three countries: 76 from four centers in Hungary, 48 from four centers in Italy and 17 from two centers in Poland. | |||||||||
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Pre-assignment
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Screening details |
Out of the 141 screened patients, 3 patients were screen failed. Therefore, 138 patients were randomized in the trial with 69 in each arm. Out of them, 2 patients prematurely discontinued the study before the injection of contrast agent. The remaining 136 patients underwent MRI examination with injection of IMP: 67 with Elucirem and 69 with Dotarem | |||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
Both participants and investigators (on-site readers) were aware of the contrast agent administered while the off-site image evaluations were performed by two independent blinded readers.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Elucirem | |||||||||
Arm description |
69 patients randomized in Elucirem group. Among them, 67 patients underwent a DSC-MRI perfusion using Elucirem (gadopiclenol) at 0.05 mmol/kg (safety population for Elucirem Arm). Out of them, 60 who had diagnostic CBV map and without major protocol deviation evaluated by off-site readers were included in the per-protocol primary analysis. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
gadopiclenol
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Elucirem (gadopiclenol) administered at a dose of 0.05 mmol/kg body weight in a single injection
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Arm title
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Dotarem | |||||||||
Arm description |
69 patients randomized in the Dotarem group and underwent a DSC-MRI perfusion using Dotarem (gadoterate meglumine) at 0.1 mmol/kg (safety population for Dotarem Arm). Among them, 64 who had diagnostic CBV map and without major protocol deviation evaluated by off-site readers were included in the per-protocol primary analysis. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
gadoterate meglumine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Dotarem (gadoterate meglumine) administered at a dose of 0.1 mmol/kg body weight in a single injection.
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Baseline characteristics reporting groups
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Reporting group title |
Elucirem
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Reporting group description |
69 patients randomized in Elucirem group. Among them, 67 patients underwent a DSC-MRI perfusion using Elucirem (gadopiclenol) at 0.05 mmol/kg (safety population for Elucirem Arm). Out of them, 60 who had diagnostic CBV map and without major protocol deviation evaluated by off-site readers were included in the per-protocol primary analysis. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Dotarem
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Reporting group description |
69 patients randomized in the Dotarem group and underwent a DSC-MRI perfusion using Dotarem (gadoterate meglumine) at 0.1 mmol/kg (safety population for Dotarem Arm). Among them, 64 who had diagnostic CBV map and without major protocol deviation evaluated by off-site readers were included in the per-protocol primary analysis. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Elucirem
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Reporting group description |
69 patients randomized in Elucirem group. Among them, 67 patients underwent a DSC-MRI perfusion using Elucirem (gadopiclenol) at 0.05 mmol/kg (safety population for Elucirem Arm). Out of them, 60 who had diagnostic CBV map and without major protocol deviation evaluated by off-site readers were included in the per-protocol primary analysis. | ||
Reporting group title |
Dotarem
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Reporting group description |
69 patients randomized in the Dotarem group and underwent a DSC-MRI perfusion using Dotarem (gadoterate meglumine) at 0.1 mmol/kg (safety population for Dotarem Arm). Among them, 64 who had diagnostic CBV map and without major protocol deviation evaluated by off-site readers were included in the per-protocol primary analysis. | ||
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End point title |
Diagnostic quality of CBV map- Off site assessment | |||||||||
End point description |
Diagnostic quality of the CBV map was assessed by the two off-site blinded readers using the following scale (poor, fair, good or excellent) and by a consensus in case of discordance between the two readers. The proportion of patients with "excellent" or "good" diagnostic quality images of Elucirem group was compared to that of Dotarem group. 124 patients (60 with Elucirem and 64 with Dotarem) who had diagnostic CBV map and without protocol major deviation were included in the per-protocol analysis.
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End point type |
Primary
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End point timeframe |
At DSC-MRI perfusion using Elucirem or Dotarem
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| Notes [1] - Patients with diagnostic CBV map and without protocol major deviation (per-protocol analysis). [2] - Patients with diagnostic CBV map and without protocol major deviation (per-protocol analysis). |
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Statistical analysis title |
Diagnostic quality of CBV map_off-site assessment | |||||||||
Statistical analysis description |
Diagnostic quality of the CBV map was assessed by the two off-site blinded readers using the following scale (poor, fair, good or excellent). The proportion of patients with "excellent" or "good" diagnostic quality images of Elucirem group was compared to that of Dotarem group. 124 patients (60 with Elucirem and 64 with Dotarem) who had diagnostic CBV map and without major protocol deviation according to the off-site evaluation were included in the per-protocol primary analysis.
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Comparison groups |
Elucirem v Dotarem
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Number of subjects included in analysis |
124
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [3] | |||||||||
Method |
% confidence Interval (CI) | |||||||||
Parameter type |
two-sided 95% confidence Interval (CI) | |||||||||
Point estimate |
-0.018
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Confidence interval |
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95% | |||||||||
sides |
2-sided
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lower limit |
-0.089 | |||||||||
upper limit |
0.053 | |||||||||
| Notes [3] - Non-inferiority was assessed by calculating the difference in proportion of patients presenting with images of excellent or good diagnostic quality between Elucirem and Dotarem groups, and by constructing a two-sided 95% confidence Interval (CI) around this difference. If the lower bound of the two-sided 95% CI was above the pre-stated margin of non-inferiority (-12%), Elucirem was declared non-inferior to Dotarem. The Wald statistical test with a continuity correction was used for CI. |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events (AE), serious or not, related to the products of study or not, that occurred from the beginning of patient’s participation in the trial (Informed Consent Form signature) were recorded until the end of the participation.
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Adverse event reporting additional description |
Safety population: the patients who received an IMP
AE reporting: AEs occurring during or after IMP administration for safety population.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
27.1
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Reporting groups
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Reporting group title |
Elucirem
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Reporting group description |
Patients who received Elucirem for DSC-MRI perfusion | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Dotarem
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Reporting group description |
Patients who received Dotarem for DSC-MRI perfusion | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
