Status:
COMPLETED
Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas
Lead Sponsor:
Guerbet
Conditions:
Brain Tumor, Primary
Brain Tumor, Recurrent
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2024
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT06057168
Start Date
September 7 2023
End Date
November 28 2024
Last Update
May 6 2025
Active Locations (11)
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1
Országos Idegtudományi Intézet - Neuroonkológiai és Intracraniá
Budapest, Hungary
2
Semmelweis Egyetem - Neurologiai Klinika
Budapest, Hungary
3
Debreceni Egyetem
Debrecen, Hungary
4
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, Hungary