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

Completed · Phase 2

Conditions studied: CNS Lesion, Blood Brain Barrier Defect

In brief

The purpose of this study was to determine a safe and effective dose of a new gadolinium-based contrast agent (GBCA) P03277 based on the Contrast to Noise Ratio (CNR) when comparing with gadobenate dimeglumine (MultiHance®) at 0.1 mmol/kg body weight (BW). Contrast to Noise Ratio (CNR), a well-known quantitative parameter directly related to contrast medium/GBCA efficacy, was chosen as the primary endpoint in order to have a precise determination of P03277 clinical dose. This was a multi-center, international, prospective, double-blind, randomized, controlled, parallel dose groups, cross-over with comparator study in male and female subjects presenting with known or highly suspected focal areas of disruption of the Blood Brain Barrier including at least one expected enhancing lesion of minimum 5 mm, who were scheduled to undergo a routine contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System.

Key facts

Study ID

NCT02633501

Run by

Guerbet

People needed

312

Starts

2016-06-01

Expected to finish

2018-01-01

Last updated by the study team

2021-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female or male adult subjects, with known or highly suspected focal areas of disrupted Blood Brain Barrier including at least one expected enhancing lesion of minimum 5 mm (long axis). This lesion had been detected on a previous imaging procedure (computerized Tomography [CT] or MRI).
• Subject scheduled for a routine contrast-enhanced MRI examination of Central Nervous System for clinical reasons and agreeing to have a second contrast-enhanced MRI examination for the purpose of the study.

You may not qualify if…

• 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.

Where it is running

• Northwestern memorial hospital — Chicago, Illinois, United States
• Beth israel deaconess medical center — Boston, Massachusetts, United States
• QUEST Research Institute — Farmington Hills, Michigan, United States
• Penn State milton S. Hershey Medical center — Hershey, Pennsylvania, United States
• University of Pensylvania medical center — Philadelphia, Pennsylvania, United States
• Temple university hospital — Philadelphia, Pennsylvania, United States
• Rhode Island hospital — Providence, Rhode Island, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of texas McGovern medical school — Houston, Texas, United States
• University of Washington — Seattle, Washington, United States
• ZNA campus Middelheim — Antwerp, Belgium
• Universitair Ziekenhuis Brussel — Brussels, Belgium
• Fakultni nemocnice Olomouc — Olomouc, Czechia
• Neurology Clinic-Semmelweis Medical University — Budapest, Hungary
• Pecsi Tudomany Egyetem Klinikai kozpont Idegsebeszeti Klinica — Pécs, Hungary
• Ospedali Riuniti di Ancona — Ancona, Italy
• Ospedale san Raffaele — Milan, Italy
• AO S. Andrea Universita La Sapienza — Roma, Italy
• Azienda policlinico Umberto — Roma, Italy
• Centro medico ABC santa fe — Mexico City, Mexico
• Axis heilsa — Monterrey, Mexico
• Clinical research institute SC — Tlalnepantla, Mexico
• Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Oddzial w Gliwicach — Gliwice, Poland
• krakowski Szpital specjalistyczny il Jana Pawla II — Krakow, Poland
• Samodzielny publiczny szpital — Lublin, Poland

Full record on ClinicalTrials.gov

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