Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children

Inclusion Criteria:

• Inclusion criteria for all patients:

1. All Patient presenting with known or suspected enhancing abnormality(ies)and/or lesion(s) in CNS or in at least one body region among head & neck,thorax (e.g. breast), abdomen (e.g. liver, pancreas and kidney), pelvis (e.g.uterus, ovary and prostate) and musculoskeletal (e.g. extremities) based on aprevious imaging procedure performed within 12 months prior to Informed ConsentForm (ICF) signature.

2. All If the patient was treated (either with radiation, surgery, biopsy, orother relevant treatments) between previous imaging evaluation and trial MRI,there should still be a high suspicion of remaining enhancing abnormality(ies)and/or lesion(s) based on available clinical information.

3. All Patient able and willing to participate in the trial.

4. All Patient affiliated to national health insurance according to localregulatory requirements.

• Inclusion criteria for adult patients:

1. A Female or male adult patient having reached legal majority age of 18 years.

2. A Patient scheduled for a contrast-enhanced MRI examination of CNS or a Bodyregion for clinical reasons and agreeing to have a second contrast-enhanced MRIexamination for the purpose of the trial.

3. A Patient having read the information and having provided his/her consent toparticipate in writing by dating and signing the informed consent prior to anytrial related procedure being conducted.

• Inclusion criteria for pediatric patients:

1. P Female or male pediatric patient from birth to 17 years. For patients agedfrom birth to 27 days, only term newborn infants are eligible.Patients may not have reached the age of 18 years at the MRI examination.

2. P Patient whose parent(s) or legal guardian (where applicable) having read theinformation provided his/her/their consent to patient's participation inwriting by dating and signing the informed consent prior to any trial relatedprocedure being conducted.

3. P Patient with capacity of understanding who received age- andmaturity-appropriate information and provided his/her assent to participate inthe trial.

4. P-PK Patient and his/her parent(s) or legal guardian (where applicable) havingread the information and provided his/her consent in writing by dating andsigning the Informed Consent form or respectively in the patient assent formtheir consent to participate in the PK analyses.

Exclusion Criteria:

• Non-inclusion criteria for all patients:

1. bis.All Patient referred for contrast-enhanced cardiac MRI as primaryexamination (e.g. imaging protocol requiring stress or more than a singleinjection of gadolinium contrast agent) except for late-enhancement cardiacimaging.

2.All Patient having received any investigational medicinal product (IMP) within 7days prior to trial entry or scheduled to receive any investigational treatmentduring the trial.

3.All Patient presenting with any contraindication to MRI examinations. 4.AllPatient having received any contrast agent (for MRI or CT) within 3 days (or 7 daysfor patients <1 year old) prior to trial product administration or scheduled toreceive any contrast agent during the trial or within 24 hours after the last trialproduct administration (or 7 days after for patients <1 year old).

5.All Patient with anticipated, current, or past condition (medical, psychological,social or geographical) that would compromise the patient's safety or her/hisability to participate in the trial in the Investigator's opinion.

6.All Female patient of childbearing potential with a positive urine pregnancy testdone within 1 day prior to each contrast agent administration and not able / notwilling to use highly effective birth-controlled method during the trial duration.

Female must have effective medically approved contraception until the last trial visit, if of childbearing potential or with amenorrhea for less than 12 months or must be surgically sterilized or post-menopausal (> 2 years amenorrhea).

7.All 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.

8.All Patient related to the Investigator or any other trial staff or relative directly involved in the trial conduct.

9.All 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 (GBCAs) (such as hypersensitivity, post contrast acute kidney injury).

• Non-inclusion criteria for adult patients:

1. A Patient with acute disease that may rapidly evolve between the 2 MRIexaminations

2. A Patient previously randomized in this trial.

3. A Patient expected/scheduled to have any treatment or medical procedure (e.g.,chemotherapy, radiotherapy, biopsy, or surgery etc.) that may impact theaspects of the imaged lesions between the 2 MRI examinations. (Patients undercorticosteroids and/or maintenance chemotherapy with a stable dose at the timeof screening visit and throughout the trial can be included).

4bis.A Patient presenting an estimated Glomerular Filtration Rate (eGFR) < 30mL/min/1.73 m^2 (based on Japanese coefficient-modified CKD-EPI (Chronic KidneyDisease - Epidemiology Collaboration) formula) assessed within 1 week prior to thefirst contrast agent administration.

• Non-inclusion criteria for pediatric patients:

1. P Patient with previously attributed IMP number in this trial.

2. P Patient with known long QT syndrome.

3. P Patient presenting an estimated Glomerular Filtration Rate (eGFR) outsideage-adjusted normal ranges (based on bedside Schwartz equation) assessed withinone week prior to contrast agent administration.