EUCTR2014-003576-23-IT
Active, not recruiting
Phase 1
P03277 Dose Finding Studyin Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) - P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
ConditionsSubject 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: PTClassification code 10067967Term: Brain injurySystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: PTClassification code 10041552Term: Spinal cord injurySystem Organ Class: 10022117 - Injury, poisoning and procedural complicationsMedDRA version: 21.1Level: LLTClassification code 10067294Term: Brain lesionSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
DrugsMultihance
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- 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)
- Sponsor
- GUERBET
- Enrollment
- 312
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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
- •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.
Outcomes
Primary Outcomes
Not specified
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