Evaluation of gadopiclenol as contrast agent in MRI (magnetic resonance imaging) of various body regions

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

1.Female or male adult patient having reached legal majority age.
2.Patient presenting with known or suspected enhancing abnormality(ies) and/or lesion(s) in at least one body region among head & neck, thorax (including breast), abdomen (including liver,
pancreas and kidney), pelvis (including uterus, ovary and prostate) and musculoskeletal (including extremities) based on a previous imaging procedure performed within 12 months prior to ICF signature. US patients are restricted to the breast in compliance with local approved indications of gadobutrol.
3.Patient scheduled for a contrast-enhanced MRI examination of a body region for clinical reasons and agreeing to have a second contrastenhanced 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 enhancing abnormality(ies) and/or 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1.Patients with known or suspected lesion(s) referred for contrastenhanced MRI of CNS or of heart or for MR Angiography.
2.Patient presenting with known class III/IV congestive heart failure according to the New York Heart Association classification (NYHA).
3.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.
4.Patient previously randomized in this trial.
5.Patient presenting with any contraindication to MRI examinations.
6.Patient having received any contrast agent (for MRI or CT) within 3 days prior to trial products administration, or scheduled to receive any contrast agent during the course of the trial or within 24 hours after the second trial product administration.
7.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).
8.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.
9.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.
10.Patient related to the Investigator or any other trial staff or relative directly involved in the trial conduct.
11.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 administration.
12.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 highly effective birth controlled method until the last trial visit).
13.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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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