Phase 2
N=280
P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
CNS Lesion · Blood Brain Barrier Defect
Bottom Line
View on ClinicalTrials.gov: NCT02633501 ↗Enrolled (actual)
280
Serious AEs
0.8%
Results posted
May 2019
Primary outcome: Primary: Contrast to Noise Ratio (CNR) Difference — -10.59; 2.18; 8.66; 14.45 Ratio — p=0.1858
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- P03277 (Drug); Gadobenate dimeglumine (Drug); MRI (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guerbet
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Contrast to Noise Ratio (CNR) Difference |
-10.59; 2.18; 8.66; 14.45; -14.14; 1.91 | 0.1858 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02633501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.