Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas (GDX-44-016)

Performance of Elucirem (Gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) Perfusion of Brain Gliomas Phase IIIb Clinical Trial

This trial aimed to study the performance of Elucirem (gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) perfusion of brain gliomas.

Study Overview

• Status: Completed
• Conditions: Brain Tumor, Recurrent; Brain Tumor, Primary
• Intervention / Treatment: Drug: Elucirem; Drug: Dotarem

Detailed Description

The trial was designed as a prospective, multi-center, randomized, controlled and parallel group comparison.

This study aimed to enrol 138 patients in Italy, Poland and Hungary.

During the course of the trial, patient underwent a DSC-MRI perfusion using Elucirem or Dotarem. A safety visit was performed 1 day after the MRI visit. Confirmation of tumor grade diagnosis, if available, was collected up to 30 days after visit 2. Primary end point was assessed by independent off-site blinded readers.

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 3

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary
    • Országos Idegtudományi Intézet - Neuroonkológiai és Intracraniá
  • Budapest, Hungary
    • Semmelweis Egyetem - Neurologiai Klinika
  • Debrecen, Hungary
    • Debreceni Egyetem
  • Pécs, Hungary
    • Pécsi Tudományegyetem Klinikai Központ
• Italy
  • Bergamo, Italy
    • Ospedale Papa Giovanni Xxiii
  • Milan, Italy
    • Ospedale San Raffaele- Neuroradiologia
  • Pavia, Italy
    • IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione
  • Roma, Italy
    • Policlinico Universitario Agostino Gemelli
• Poland
  • Gdansk, Poland
    • Uniwersyteckie Centrum Kliniczne w Gdansku
  • Krakow, Poland
    • Szpital Specjalistyczny im.L.Rydygiera
  • Lublin, Poland
    • Independent Public Teaching Hospital no 1 Department of Interventional Radiology and Diagnostic Imaging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female or male adult patient (patient having reached legal majority age).
2. Patient with naive or recurrent primary glial tumor detected at a previous Computed Tomography (CT) or MR imaging, and scheduled for a follow-up contrast-enhanced MRI. Tumor grade (confirmed or highly suspected) should be available in patients' medical records.
3. Patient or, if the patient is unable to provide informed consent, the patient's legally acceptable representative and/or impartial witness, having read the information and having provided patient's consent to participate in writing by dating and signing the informed consent prior to any trial related procedure being conducted.
4. Patient affiliated to national health insurance according to local regulatory requirements.

Exclusion Criteria:

1. Patient with known contra-indication(s) to the use or with known sensitivity to one of the products under investigation or to other Gadolinium-Based Contrast Agents (GBCA) (such as hypersensitivity, post-contrast acute kidney injury).
2. Patient presenting with any contraindication to MRI examinations.
3. Post treatment patient presenting with pseudo-progression instead of tumor recurrency.
4. Patient presenting with severe renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m² assessed within 1 week prior to contrast agent injection.
5. Patient having received any contrast agent (for MRI or CT) within 3 days prior to IMP administration or scheduled to receive any contrast agent within 24 hours after IMP administration.
6. Pregnant female patient (a female patient of childbearing potential or with amenorrhea for less than 12 months must have a negative pregnancy test within 1 day prior to trial MRI and must be using medically approved contraception method until the last trial visit).
7. Patient having received any investigational medicinal product within 7 days prior to trial entry or scheduled to receive any investigational treatment in the course of the trial.
8. Patient previously randomized in this trial.
9. Patient with anticipated, current or past condition (medical, psychological, social or geographical) that would compromise the patient's safety or her/his ability to participate in the trial.
10. Patient unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits and/or unlikelihood of completing the trial.
11. Patient related to the investigator or any other trial staff or relative directly involved in the trial conduct.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elucirem; Patient underwent a DSC-MRI perfusion using Elucirem.	Drug: Elucirem; Intravenous administration; Other Names: gadopiclenol
Active Comparator: Dotarem; Patient underwent a DSC-MRI perfusion using Dotarem.	Drug: Dotarem; Intravenous administration; Other Names: gadoteric acid; gadoterate meglumine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Quality of Cerebral Blood Volume (CBV) Map of Dynamic Susceptibility Contrast MRI (DSC-MRI) Perfusion	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.	From beginning to end of procedure for DSC-MRI perfusion using Elucirem or Dotarem

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the diagnostic quality of CBV perfusion map for Elucirem® and Dotarem® (on-site assessment)	Diagnostic quality of the CBV map will be assessed by on-site readers using the same 4-point scale as the one used for primary evaluation criterion	Evaluation is performed within 1 month after obtaining MRI scan and CBV map
To compare the performance of DSC-MRI perfusion using Elucirem® at 0.05 mmol/kg to DSC-MRI using Dotarem® at 0.1 mmol/kg in differentiating glioma grade through the quantification of the relative CBV (rCBV) (off-site assessment)	The rCBV will be calculated on the CBV perfusion maps generated for each DSC-MRI perfusion. The regions of interest (ROIs) will be placed by off-site readers on the tumor for providing tumor CBV and also on normal tissue (contralateral normal-appearing white matter) for providing referenced CBV.	Evaluation is performed within 6 months after obtaining MRI scan and CBV map
To assess the reliability of the T2* signal intensity time curve in terms of confidence in diagnosis in DSC-MRI perfusion using Elucirem® at 0.05 mmol/kg (on-site and off-site assessments)	T2* signal intensity time curve will be visually assessed by on-site and off-site readers for the reliability of the curve in providing sufficient information for diagnosis purpose. The Full-Width at Half-Maximum (FWHM) and the maximum signal drop will be measured by off-site readers only.	Evaluation is performed within 6 months after obtaining MRI scan and CBV map
To expand the previously established safety profile of Elucirem® at 0.05 mmol/kg in terms of incidence of adverse events	Adverse events, serious or not, related to IMP or not, that occur from the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation.	Evaluation is performed from the beginning of patient's participation in the trial (Informed Consent Form signature) until the end of the participation (maximum 37 days).

Collaborators and Investigators

• Sponsor: Guerbet
• Investigators: Study Director: Frantz Hebert, Guerbet

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2023
• Primary Completion (Actual): November 28, 2024
• Study Completion (Actual): November 28, 2024

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 25, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; gadopiclenol; gadoterate meglumine
• Other Study ID Numbers: GDX-44-016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No