CompletedPhase 3

Performance of Elucirem in DSC-MRI Perfusion of Brain Gliomas

Hungary, Italy138 participantsStarted 2023-09-07

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Diagnostic Quality of Cerebral Blood Volume (CBV) Map of Dynamic Susceptibility Contrast MRI (DSC-MRI) Perfusion

Timeframe: From beginning to end of procedure for DSC-MRI perfusion using Elucirem or Dotarem

Trial details

NCT IDNCT06057168

SponsorGuerbet

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-28

Results submitted2025-11-18

View on ClinicalTrials.gov More Brain Tumor, Primary trials