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COMPLETEDPHASE3

Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas

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

NCT06057168•Guerbet

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (11)

Országos Idegtudományi Intézet - Neuroonkológiai és Intracraniá

Budapest, Hungary

Semmelweis Egyetem - Neurologiai Klinika

Budapest, Hungary

Debreceni Egyetem

Debrecen, Hungary

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, Hungary

Ospedale Papa Giovanni XXIII

Bergamo, Italy

Ospedale San Raffaele- Neuroradiologia

Milan, Italy

IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione

Pavia, Italy

Policlinico Universitario Agostino Gemelli

Roma, Italy

Uniwersyteckie Centrum Kliniczne w Gdansku

Gdansk, Poland

Szpital Specjalistyczny im.L.Rydygiera

Krakow, Poland

Key Dates

Start Date

September 7, 2023

Primary Completion Date

November 28, 2024

Completion Date

November 28, 2024

Last Updated

January 29, 2026

Enrollment

138

ACTUAL participants

Conditions

Brain Tumor, PrimaryBrain Tumor, Recurrent

Interventions

Elucirem

DRUG

Dotarem

DRUG

Glutamate Excitotoxicity and Its Role in Glioblastoma Biology

NCT05775458

Brain Tumor, Primary

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RECRUITINGPHASE1/PHASE2

Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

NCT03213002

Glioblastoma Multiforme (GBM)Glioblastoma+7 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas

Inclusion Criteria

Exclusion Criteria

Glutamate Excitotoxicity and Its Role in Glioblastoma Biology

Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)

Evaluation of Fluoxetine and Cytotoxic Lysosomal Stress in Glioma (FLIRT)

Research on the Safety and Efficacy of Intraoperative Radiation Therapy in Malignant Cerebral Tumor

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