Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.