P03277 Dose Finding Study in Central Nervous System (CNS)Magnetic Resonance Imaging (MRI)

Phase 1

Conditions: Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
MedDRA version: 21.1Level: PTClassification code 10067967Term: Brain injurySystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: PTClassification code 10041552Term: Spinal cord injurySystem Organ Class: 10022117 - Injury, poisoning and procedural complications
Subject presenting, at the time of inclusion, with known or highly suspected focal areas of disrupted Blood Brain Barrier (BBB)(e.g., primary and secondary tumors, focal inflammatory or demyelinating disorders) including at least one expected enhancinglesion of minimum 5 mm (long axis)
MedDRA version: 21.1Level: LLTClassification code 10067294Term: Brain lesionSystem Organ Class: 10029205 - Nervous system disorders

Registration Number: EUCTR2014-003576-23-IT

Lead Sponsor: GUERBET

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 312

Inclusion Criteria

1.Female or male adult subject (subject having reached legal majority age).
2.Subject presenting, at the time of inclusion, with known or highly suspected focal areas of disrupted Blood Brain Barrier (BBB)
(e.g., primary and secondary tumors, focal inflammatory disorders) including at least one expected enhancing
lesion of minimum 5 mm (long axis). This lesion must have been detected on a previous imaging procedure (computerized
Tomography (CT) or MRI).
3.Subject scheduled for a routine CNS contrast-enhanced MRI examination for clinical reasons and agreeing to have a second
contrast-enhanced MRI examination for the purpose of the study.
4.Subject able and willing to participate to the study.
5.Subject having read the information and having provided his/her consent to participate in writing by dating and signing the
informed consent prior to any study related procedure being conducted.
6.Subject 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 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1.Subject presenting with acute or chronic Grade III (at least) renal insufficiency, defined as an estimated Glomerular Filtration
Rate (eGFR) <60 mL/min/1.73 m² based on one
eGFR assessment performed the
day of the MRI prior to the first
contrast agent injection 2.Subject presenting with known class III/IV congestive heart failure according to the New York Heart Association classification
(NYHA).
3.Pregnant or breast-feeding female subject (a female subject of childbearing potential or with amenorrhea for less than 12
months must have a negative urine or serum pregnancy test within 24 hours prior to study MRI and must be using a medically
approved contraception method* until the last study visit).
4.Subject having received any investigational medicinal product within 30 days prior to study entry.
5.Subject previously enrolled in this study.
6.Subject presenting with any contraindication to MRI examinations.
7.Subject with known contra-indication(s) to the use or with known sensitivity to one of the products under investigation or other
GBCAs.
8.Subject having received any contrast agent (MRI or CT) within 3 days prior to study products administration, or scheduled to
receive any contrast agent during the course of the study or within 24 hours after the second study product administration.
9.Subject having received any treatment or medical procedure (e.g. chemotherapy, radiotherapy, biopsy or surgery etc…) within
7 days prior to the first MRI or is expected/ scheduled to have a change in any treatment or medical procedure (e.g.
chemotherapy, radiotherapy, biopsy or surgery etc…) in-between the 2 MRI examinations.
10.Subject with anticipated, current or past condition (medical, psychological, social or geographical) that would compromise the
subject’s safety or her/his ability to participate in the study.
11.Subject unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits and/or
unlikelihood of completing the study.
12.Subject related to the Investigator or any other study staff or relative directly involved in the study conduct.13.Subject presenting with acute
relapse of multiple sclerosis.
* medically approved contraception methods include: female sterilization, barrier methods of contraception (condom or occlusive
cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository), use of oral, injected or
implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure
rate <1%), for example hormone vaginal ring or transdermal hormone contraception, placement of an Intrauterine Device (IUD) or
Intrauterine System (IUS).

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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