Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Primary objective 1: o To demonstrate the superiority of gadopiclenol-enhanced MRI at 0.05 mmol/kg body weight (BW) compared to unenhanced MRI for patient referred for contrast-enhanced MRI of CNS, in terms of 3 lesion visualization co-primary criteria (border delineation, internal morphology and degree of contrast enhancement) using the patient as his/her own control. Primary objective 2: o To demonstrate the non-inferiority of gadopiclenol at 0.05 mmol/kg compared to gadobutrol at 0.1 mmol/kg in terms of 3 lesion visualization co-primary criteria (border delineation, internal morphology, degree of contrast enhancement) for patient referred for contrast-enhanced MRI of CNS. For FDA, the primary objective 1 is to be achieved. The primary objective 2 will serve as one of the secondary objectives. For EMA, both primary objectives 1 and 2 are to be achieved.

Gadopiclenol

Gadopiclenol

Solution for intravenous injection

0.5

Primary Outcome Measures :
lesion visualization criteria for gadopiclenol-enhanced MRI compared to unenhanced MRI [ Time Frame: 1 day procedure ]
The lesion visualization criteria is based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by independent readers for the 3 most representative lesions.

Lesion visualization criteria for gadopiclenol compared to gadobutrol [ Time Frame: 1 day procedure ]
the lesion visualization criteria is based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement assessed on the images acquired during the MRI performed with gadopiclenol and those performed with gadobutrol.

For each reader, only matching lesion between paired images of gadobutrol and gadopiclenol will be considered

1. Female or male adult patient (patient having reached legal majority age).
2. Patient presenting with known or highly suspected CNS lesion(s) with focal areas of
disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) based on
results of a previous imaging procedure such as Computed Tomography (CT) or MRI,
which should have been performed within 12 months prior to ICF signature.
3. Patient scheduled for a CNS contrast-enhanced MRI examination for clinical reasons and
agreeing to have a second contrast-enhanced MRI examination for the purpose of the trial.
4. If the patient was treated (either with radiation, surgery, biopsy or other relevant
treatments) between previous imaging evaluation and trial MRI, there should still be a
high suspicion of remaining lesion(s) on the basis of available clinical information.
5. Patient able and willing to participate in the trial.
6. Patient having read the information and having provided his/her consent to participate in
writing by dating and signing the informed consent prior to any trial related procedure
being conducted.
7. Patient affiliated to national health insurance according to local regulatory requirements.

1. Patient presenting extra cranial lesions and/or extra-dural lesions.
2. Patient presenting with an acute relapse of multiple sclerosis as qualifying CNS lesion.
3. Patient presenting with known class III/IV congestive heart failure according to the New
York Heart Association classification (NYHA).
4. Patient having received any investigational medicinal product within 7 days prior to trial
entry or schedule to receive any investigational treatment in the course of the trial.
5. Patient presenting with any contraindication to MRI examinations.
6. Patient previously randomized in this trial.
7. Patient having received any contrast agent (MRI or CT) within 3 days prior to first trial
product administration, or scheduled to receive any contrast agent during the course of the
trial or within 24 hours after the second trial product administration.
8. Patient expected/scheduled to have any treatment or medical procedure (e.g.
chemotherapy, radiotherapy, biopsy or surgery etc…) that may impact the aspects of the
imaged lesions between the 2 MRI examinations. (Patients under corticosteroids and/or
maintenance chemotherapy with a stable dose at the time of screening visit and throughout
the trial can be included).
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.
Non-inclusion criteria to be checked at V1, V2 and V4:
12. Patient presenting with acute or chronic renal insufficiency, defined as an estimated
Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m² assessed within 1 day prior to
each contrast agent injection.
13. Pregnant or breast-feeding female patient (a female patient of childbearing potential or
with amenorrhea for less than 12 months must have a negative urine pregnancy test within
1 day prior to trial MRI and must be using a medically approved contraception method*
until the last trial visit).
14. 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).