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

• ClinicalTrials.gov Identifier: NCT06057168
• Recruitment Status: Recruiting
• First Posted: September 28, 2023
• Sponsor: Guerbet
• Information provided by (Responsible Party): Guerbet

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Brain Tumor, Primary; Brain Tumor, Recurrent	Drug: Elucirem; Drug: Dotarem	Phase 3

Detailed Description:

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

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

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 138 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Performance of Elucirem® (Gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) Perfusion of Brain Gliomas Phase IIIb Clinical Trial
• Actual Study Start Date: September 7, 2023
• Estimated Primary Completion Date: April 29, 2024
• Estimated Study Completion Date: April 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Elucirem®; Patient will undergo a DSC-MRI perfusion using Elucirem®	Drug: Elucirem; Intravenous administration; Other Name: gadopiclenol
Active Comparator: Dotarem®; Patient will undergo a DSC-MRI perfusion using Dotarem®	Drug: Dotarem; Intravenous administration; Other Names: gadoterate meglumine; gadoteric acid

Outcome Measures

Primary Outcome Measures :

1. 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 Cerebral Blood Volume perfusion map [ Time Frame: Evaluation is performed within 6 months after obtaining MRI scan and CBV map ]
   Diagnostic quality of the CBV map will be assessed by off-site readers using a 4-point scale with the grades: poor, fair, good or excellent

Secondary Outcome Measures :

1. To evaluate the diagnostic quality of CBV perfusion map for Elucirem® and Dotarem® (on-site assessment) [ Time Frame: Evaluation is performed within 1 month after obtaining MRI scan and CBV map ]
   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
2. 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) [ Time Frame: Evaluation is performed within 6 months after obtaining MRI scan and CBV map ]
   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.
3. 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) [ Time Frame: Evaluation is performed within 6 months after obtaining MRI scan and CBV map ]
   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.
4. To expand the previously established safety profile of Elucirem® at 0.05 mmol/kg in terms of incidence of adverse events [ Time Frame: 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). ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Sophie Rollin, PhD; +331 45 91 50 00; sophie.rollin@guerbet.com

Locations

Hungary

Országos Idegtudományi Intézet - Neuroonkológiai és Intracraniá; Not yet recruiting

Budapest, Hungary

Contact: Attila Bago, MD

Semmelweis Egyetem - Neurologiai Klinika; Not yet recruiting

Budapest, Hungary

Contact: Daniel Bereczki, MD

Debreceni Egyetem; Not yet recruiting

Debrecen, Hungary

Contact: Gábor Hutóczki, MD

Pecsi Tudomanyegyetem Klinikai Kozpont; Not yet recruiting

Pécs, Hungary

Contact: Attila Schwarc, MD

Italy

Ospedale Papa Giovanni XXIII; Not yet recruiting

Bergamo, Italy

Contact: Simonetta Gerevini, MD

Ospedale San Raffaele- Neuroradiologia; Not yet recruiting

Milano, Italy

Contact: Nicoletta Anzalone, MD

IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione; Recruiting

Pavia, Italy

Contact: Anna Pichiecchio, MD

Policlinico Universitario Agostino Gemelli; Not yet recruiting

Roma, Italy

Contact: Simona Gaudino, MD

Poland

Uniwersyteckie Centrum Kliniczne w Gdansku; Not yet recruiting

Gdańsk, Poland

Contact: Katarzyna Dziadziuszko, MD

Szpital Specjalistyczny im.L.Rydygiera; Not yet recruiting

Kraków, Poland

Contact: Ewa Janczyk, MD

Independent Public Teaching Hospital no 1 Department of Interventional Radiology and Diagnostic Imaging; Not yet recruiting

Lublin, Poland

Contact: Radosław Pietura, MD

Sponsors and Collaborators

Guerbet

Investigators

• Study Director: Frantz Hebert; Guerbet

More Information

• Responsible Party: Guerbet
• ClinicalTrials.gov Identifier: NCT06057168
• Other Study ID Numbers: GDX-44-016
• First Posted: September 28, 2023
• Last Update Posted: May 3, 2024
• Last Verified: September 2023

• 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

Additional relevant MeSH terms:

Brain Neoplasms; Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action