MedTrace Logo

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

NCT02633501 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2021-10-25

Study results available
· View outcomes & findings →

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.

Conditions

  • CNS Lesion
  • Blood Brain Barrier Defect

Interventions

DRUG

P03277

Single intravenous (IV) bolus injection at a rate of 2 mL/second

DRUG

Gadobenate dimeglumine

Single IV bolus injection at a rate of 2 mL/second

DEVICE

MRI

Sponsors & Collaborators

  • Guerbet

    lead INDUSTRY

Principal Investigators

  • Martin BENDSZUS, MD · University Hospital Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-01-31
Completion
2018-01-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • Hungary
  • Italy
  • Mexico
  • Poland
  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02633501 on ClinicalTrials.gov