Clinical trial NCT06057168: Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas
Official title: Performance of Elucirem® (Gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) Perfusion of Brain Gliomas Phase IIIb Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Brain Tumor, Primary
Brain Tumor, Recurrent
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2023-09-28
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Evaluation is performed within 6 months after obtaining MRI scan and CBV map
Secondary outcomes:
measure: To evaluate the diagnostic quality of CBV perfusion map for Elucirem® and Dotarem® (on-site assessment)
timeFrame: Evaluation is performed within 1 month after obtaining MRI scan and CBV map
measure: 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)
timeFrame: Evaluation is performed within 6 months after obtaining MRI scan and CBV map
measure: 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)
timeFrame: Evaluation is performed within 6 months after obtaining MRI scan and CBV map
measure: To expand the previously established safety profile of Elucirem® at 0.05 mmol/kg in terms of incidence of adverse events
timeFrame: 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).
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Országos Idegtudományi Intézet - Neuroonkológiai és Intracraniá
city: Budapest
country: Hungary
facility: Semmelweis Egyetem - Neurologiai Klinika
city: Debrecen
country: Hungary
facility: Debreceni Egyetem
city: Pécs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont
city: Bergamo
country: Italy
facility: Ospedale Papa Giovanni XXIII
city: Milano
country: Italy
facility: Ospedale San Raffaele- Neuroradiologia
city: Pavia
country: Italy
facility: IRCCS C.Mondino, Istituto Neurologico Nazionale, Fondazione
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne w Gdansku
city: Kraków
country: Poland
facility: Szpital Specjalistyczny im.L.Rydygiera
city: Lublin
country: Poland
facility: Independent Public Teaching Hospital no 1 Department of Interventional Radiology and Diagnostic Imaging
Study officials:
affiliation: Guerbet
name: Frantz Hebert
role: STUDY_DIRECTOR
References: