Trial Outcomes & Findings for Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas (NCT NCT06057168)

Last Updated: 2026-01-29

Results Overview

Diagnostic quality of the CBV map obtained from DSC-MRI perfusion for each patient 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 major protocol deviation were included in the per-protocol primary analysis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

138 participants

Primary outcome timeframe

From beginning to end of procedure for DSC-MRI perfusion using Elucirem or Dotarem

Results posted on

2026-01-29

Participant Flow

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.

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. A total of 124 patients were included in the per-protocol primary analysis: 60 with Elucirem and 64 with Dotarem.

Participant milestones

Participant milestones
Measure	Elucirem Patient underwent a DSC-MRI perfusion using Elucirem (gadopiclenol) at 0.05 mmol/kg Elucirem: Intravenous administration	Dotarem Patient underwent a DSC-MRI perfusion using Dotarem (gadoterate meglumine) at 0.1 mmol/kg Dotarem: Intravenous administration
Overall Study STARTED	69	69
Overall Study COMPLETED	67	69
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Elucirem Patient underwent a DSC-MRI perfusion using Elucirem (gadopiclenol) at 0.05 mmol/kg Elucirem: Intravenous administration	Dotarem Patient underwent a DSC-MRI perfusion using Dotarem (gadoterate meglumine) at 0.1 mmol/kg Dotarem: Intravenous administration
Overall Study Adverse Event	2	0

Baseline Characteristics

Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Elucirem n=67 Participants Patient underwent a DSC-MRI perfusion using Elucirem (gadopiclenol) at 0.05 mmol/kg Elucirem: Intravenous administration	Dotarem n=69 Participants Patient underwent a DSC-MRI perfusion using Dotarem (gadoterate meglumine) at 0.1 mmol/kg Dotarem: Intravenous administration	Total n=136 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=41 Participants	51 Participants n=1581 Participants	102 Participants n=4626 Participants
Age, Categorical >=65 years	16 Participants n=41 Participants	18 Participants n=1581 Participants	34 Participants n=4626 Participants
Age, Continuous	54.9 years STANDARD_DEVIATION 14.23 • n=41 Participants	54.6 years STANDARD_DEVIATION 14.71 • n=1581 Participants	54.8 years STANDARD_DEVIATION 14.42 • n=4626 Participants
Sex: Female, Male Female	23 Participants n=41 Participants	30 Participants n=1581 Participants	53 Participants n=4626 Participants
Sex: Female, Male Male	44 Participants n=41 Participants	39 Participants n=1581 Participants	83 Participants n=4626 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Race (NIH/OMB) Asian	0 Participants n=41 Participants	1 Participants n=1581 Participants	1 Participants n=4626 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Race (NIH/OMB) Black or African American	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Race (NIH/OMB) White	67 Participants n=41 Participants	68 Participants n=1581 Participants	135 Participants n=4626 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants

PRIMARY outcome

Timeframe: From beginning to end of procedure for DSC-MRI perfusion using Elucirem or Dotarem

Population: Per-protocol analysis included 124 patients (60 with Elucirem and 64 with Dotarem) with diagnostic CBV map and without protocol major deviation evaluated by two independent off-site readers.

Outcome measures

Outcome measures
Measure	Elucirem n=60 Participants Patient underwent a DSC-MRI perfusion using Elucirem (gadopiclenol) at 0.05 mmol/kg Elucirem: Intravenous administration	Dotarem n=64 Participants Patient underwent a DSC-MRI perfusion using Dotarem (gadoterate meglumine) at 0.1 mmol/kg Dotarem: Intravenous administration
Diagnostic Quality of Cerebral Blood Volume (CBV) Map of Dynamic Susceptibility Contrast MRI (DSC-MRI) Perfusion	58 Participants	63 Participants

Adverse Events

Elucirem

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Dotarem

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Elucirem n=67 participants at risk Patient underwent a DSC-MRI perfusion using Elucirem (gadopiclenol) at 0.05 mmol/kg Elucirem: Intravenous administration	Dotarem n=69 participants at risk Patient underwent a DSC-MRI perfusion using Dotarem (gadoterate meglumine) at 0.1 mmol/kg Dotarem: Intravenous administration
Injury, poisoning and procedural complications Incorrect dose administered	3.0% 2/67 • Number of events 2 • From the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation (1 day after IMP administration for the patients without biopsy or surgery done, maximum 30 days after IMP administration for the patients with biopsy or surgery done). AEs occurring during or after IMP administration until the end of the participation (maximum 30 days) for safety population. Safety population: the patients who received an IMP of the study (67 patients received an injection of Elucirem group and 69 patients received an injection of Dotarem).	0.00% 0/69 • From the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation (1 day after IMP administration for the patients without biopsy or surgery done, maximum 30 days after IMP administration for the patients with biopsy or surgery done). AEs occurring during or after IMP administration until the end of the participation (maximum 30 days) for safety population. Safety population: the patients who received an IMP of the study (67 patients received an injection of Elucirem group and 69 patients received an injection of Dotarem).
Injury, poisoning and procedural complications Incorrect dose administered by device	0.00% 0/67 • From the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation (1 day after IMP administration for the patients without biopsy or surgery done, maximum 30 days after IMP administration for the patients with biopsy or surgery done). AEs occurring during or after IMP administration until the end of the participation (maximum 30 days) for safety population. Safety population: the patients who received an IMP of the study (67 patients received an injection of Elucirem group and 69 patients received an injection of Dotarem).	1.4% 1/69 • Number of events 1 • From the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation (1 day after IMP administration for the patients without biopsy or surgery done, maximum 30 days after IMP administration for the patients with biopsy or surgery done). AEs occurring during or after IMP administration until the end of the participation (maximum 30 days) for safety population. Safety population: the patients who received an IMP of the study (67 patients received an injection of Elucirem group and 69 patients received an injection of Dotarem).
Gastrointestinal disorders Diarrhoea	1.5% 1/67 • Number of events 1 • From the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation (1 day after IMP administration for the patients without biopsy or surgery done, maximum 30 days after IMP administration for the patients with biopsy or surgery done). AEs occurring during or after IMP administration until the end of the participation (maximum 30 days) for safety population. Safety population: the patients who received an IMP of the study (67 patients received an injection of Elucirem group and 69 patients received an injection of Dotarem).	0.00% 0/69 • From the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation (1 day after IMP administration for the patients without biopsy or surgery done, maximum 30 days after IMP administration for the patients with biopsy or surgery done). AEs occurring during or after IMP administration until the end of the participation (maximum 30 days) for safety population. Safety population: the patients who received an IMP of the study (67 patients received an injection of Elucirem group and 69 patients received an injection of Dotarem).
Gastrointestinal disorders Nausea	1.5% 1/67 • Number of events 1 • From the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation (1 day after IMP administration for the patients without biopsy or surgery done, maximum 30 days after IMP administration for the patients with biopsy or surgery done). AEs occurring during or after IMP administration until the end of the participation (maximum 30 days) for safety population. Safety population: the patients who received an IMP of the study (67 patients received an injection of Elucirem group and 69 patients received an injection of Dotarem).	0.00% 0/69 • From the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation (1 day after IMP administration for the patients without biopsy or surgery done, maximum 30 days after IMP administration for the patients with biopsy or surgery done). AEs occurring during or after IMP administration until the end of the participation (maximum 30 days) for safety population. Safety population: the patients who received an IMP of the study (67 patients received an injection of Elucirem group and 69 patients received an injection of Dotarem).
Gastrointestinal disorders Vomiting	1.5% 1/67 • Number of events 1 • From the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation (1 day after IMP administration for the patients without biopsy or surgery done, maximum 30 days after IMP administration for the patients with biopsy or surgery done). AEs occurring during or after IMP administration until the end of the participation (maximum 30 days) for safety population. Safety population: the patients who received an IMP of the study (67 patients received an injection of Elucirem group and 69 patients received an injection of Dotarem).	0.00% 0/69 • From the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation (1 day after IMP administration for the patients without biopsy or surgery done, maximum 30 days after IMP administration for the patients with biopsy or surgery done). AEs occurring during or after IMP administration until the end of the participation (maximum 30 days) for safety population. Safety population: the patients who received an IMP of the study (67 patients received an injection of Elucirem group and 69 patients received an injection of Dotarem).
Nervous system disorders Headache	0.00% 0/67 • From the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation (1 day after IMP administration for the patients without biopsy or surgery done, maximum 30 days after IMP administration for the patients with biopsy or surgery done). AEs occurring during or after IMP administration until the end of the participation (maximum 30 days) for safety population. Safety population: the patients who received an IMP of the study (67 patients received an injection of Elucirem group and 69 patients received an injection of Dotarem).	1.4% 1/69 • Number of events 1 • From the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation (1 day after IMP administration for the patients without biopsy or surgery done, maximum 30 days after IMP administration for the patients with biopsy or surgery done). AEs occurring during or after IMP administration until the end of the participation (maximum 30 days) for safety population. Safety population: the patients who received an IMP of the study (67 patients received an injection of Elucirem group and 69 patients received an injection of Dotarem).

Additional Information

Frantz Hebert, Global Head of Clinical Development

Guerbet

Phone: +33 680249334

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place