Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas

NCT06057168 | Completed Phase 3 Results

• 1 other identifier: GDX-44-016
• Study Type: interventional
• Target: 138
• Locations: 3 countries
• Sites: 11

Brief Summary

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

Conditions

Brain Tumor, Primary; Brain Tumor, Recurrent

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Elucirem

EXPERIMENTAL

Patient underwent a DSC-MRI perfusion using Elucirem.

Drug: Elucirem

Dotarem

ACTIVE COMPARATOR

Patient underwent a DSC-MRI perfusion using Dotarem.

Drug: Dotarem

Interventions

Elucirem DRUG

Intravenous administration

Also known as: gadopiclenol

Elucirem

Dotarem DRUG

Intravenous administration

Also known as: gadoterate meglumine, gadoteric acid

Dotarem

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male adult patient (patient having reached legal majority age).
• 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.
• 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.
• Patient affiliated to national health insurance according to local regulatory requirements.

You may not qualify if:

• 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).
• Patient presenting with any contraindication to MRI examinations.
• Post treatment patient presenting with pseudo-progression instead of tumor recurrency.
• 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.
• 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.
• 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).
• 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.
• Patient previously randomized in this trial.
• 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.
• 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.
• Patient related to the investigator or any other trial staff or relative directly involved in the trial conduct.

Sponsors & Collaborators

• Guerbet: lead

Study Sites (11)

Országos Idegtudományi Intézet - Neuroonkológiai és Intracraniá

Budapest, Hungary

Location

Semmelweis Egyetem - Neurologiai Klinika

Budapest, Hungary

Location

Debreceni Egyetem

Debrecen, Hungary

Location

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, Hungary

Location

Ospedale Papa Giovanni XXIII

Bergamo, Italy

Location

Ospedale San Raffaele- Neuroradiologia

Milan, Italy

Location

IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione

Pavia, Italy

Location

Policlinico Universitario Agostino Gemelli

Roma, Italy

Location

Uniwersyteckie Centrum Kliniczne w Gdansku

Gdansk, Poland

Location

Szpital Specjalistyczny im.L.Rydygiera

Krakow, Poland

Location

Independent Public Teaching Hospital no 1 Department of Interventional Radiology and Diagnostic Imaging

Lublin, Poland

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

gadopiclenol; gadoterate meglumine

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Frantz Hebert, Global Head of Clinical Development
• Organization: Guerbet

frantz.hebert@guerbet.com

+33 680249334

Study Officials

• Frantz Hebert

  Guerbet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 28, 2023
• Study Start: September 7, 2023
• Primary Completion: November 28, 2024
• Study Completion: November 28, 2024
• Last Updated: January 29, 2026
• Results First Posted: January 29, 2026

Record last verified: 2025-11

Locations

HU (4); PL (3); IT (4)