Naive or recurrent primary glial tumor MedDRA version: 24.0 Level: LLT Classification code 10056941 Term: MRI brain System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Elucirem
Product Name: Elucirem
Product Code: P03277/G03277
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Gadopiclenol
CAS Number: 933983-75-6
Current Sponsor code: P032
Sponsors
Guerbet
Eligibility
Sex/Gender
All
Inclusion 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 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, 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 112 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: Patient presenting with one or more of the following non-inclusion criteria must not be included in the trial: 1. Patient with known contra-indication(s) to the use or with known sensitivity to one of the products under investigation or to other GBCAs (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 (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 CBV perfusion map (off-site assessment).;Secondary Objective: - To evaluate the diagnostic quality of CBV perfusion map for Elucirem® and Dotarem® (on-site assessment) - To compare the performance of DSC-MRI perfusion using Elucirem® at 0.05 mmol/kg to DSCMRI using Dotarem® at 0.1 mmol/kg in differentiating glioma grade through the quantification of the relative CBV (off-site assessment) - 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) - To expand the previously established safety profile of Elucirem® at 0.05 mmol/kg in terms of incidence of adverse events ;Primary end point(s): The primary endpoint of the trial is the proportion of patients presenting with images of excellent and good quality, according to off-site readers, in the Elucirem® and the Dotarem® arm.;Timepoint(s) of evaluation of this end point: After contrast injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) proportion of patients presenting with images of excellent and good quality, according to on-site reader, in the Elucirem® and the Dotarem® arm. 2) Quantification of the relative cerebral blood volume and assessment of the T2* signal intensity time curve 3) Collection and assessment of all adverse events ;Timepoint(s) of evaluation of this end point: The timepoint of secondary end point 1) and 2) is after contrast injection Secondary endpoint 3) will be from ICF signature up to end of patient participation | — |
Countries
Hungary
Contacts
Public ContactGlobal Regulatory Pharmacist
Guerbet
Outcome results
None listed