NCT02633501

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2016

Geographic Reach
8 countries

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

May 8, 2019

Completed
Last Updated

October 25, 2021

Status Verified

October 1, 2021

Enrollment Period

1.6 years

First QC Date

December 15, 2015

Results QC Date

January 31, 2019

Last Update Submit

October 4, 2021

Conditions

CNS LesionBlood Brain Barrier Defect

Outcome Measures

Primary Outcomes (1)

  • Contrast to Noise Ratio (CNR) Difference

    The Contrast-to-Noise Ratio (CNR) was calculated from the signal intensity measurement of maximum 3 enhanced lesions by 3 independent blinded readers. Only lesions detected by both MRIs after lesion tracking were used. The difference in CNR was calculated as follow: CNR (P03277) - CNR (gadobenate dimeglumine).

    1 day procedure

Study Arms (4)

Subset 1 Arm 1

EXPERIMENTAL

One of the two doses of P03277 (0.05 or 0.1 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI

Drug: P03277Drug: Gadobenate dimeglumineDevice: MRI

Subset 1 Arm 2

EXPERIMENTAL

Gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI then one of the two doses of P03277 (0.05 or 0.1 mmol/kg)-enhanced MRI

Drug: P03277Drug: Gadobenate dimeglumineDevice: MRI

Subset 2 Arm 1

EXPERIMENTAL

One of the four doses of P03277 (0.025, 0.05, 0.1 or 0.2 mmol/kg)-enhanced MRI then gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI

Drug: P03277Drug: Gadobenate dimeglumineDevice: MRI

Subset 2 Arm 2

EXPERIMENTAL

Gadobenate dimeglumine (0.1 mmol/kg)-enhanced MRI then one of the four doses of P03277 (0.025, 0.05, 0.1 or 0.2 mmol/kg)-enhanced MRI

Drug: P03277Drug: Gadobenate dimeglumineDevice: MRI

Interventions

P03277DRUG

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

Also known as: Gadopiclenol
Subset 1 Arm 1Subset 1 Arm 2Subset 2 Arm 1Subset 2 Arm 2
Gadobenate dimeglumineDRUG

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

Also known as: MultiHance
Subset 1 Arm 1Subset 1 Arm 2Subset 2 Arm 1Subset 2 Arm 2
MRIDEVICE
Subset 1 Arm 1Subset 1 Arm 2Subset 2 Arm 1Subset 2 Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Northwestern memorial hospital

Chicago, Illinois, 60611, United States

Location

Beth israel deaconess medical center

Boston, Massachusetts, 02215, United States

Location

QUEST Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Penn State milton S. Hershey Medical center

Hershey, Pennsylvania, 17033, United States

Location

University of Pensylvania medical center

Philadelphia, Pennsylvania, 19104, United States

Location

Temple university hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Rhode Island hospital

Providence, Rhode Island, 02903, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of texas McGovern medical school

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

ZNA campus Middelheim

Antwerp, Belgium

Location

Universitair Ziekenhuis Brussel

Brussels, Belgium

Location

Fakultni nemocnice Olomouc

Olomouc, Czechia

Location

Neurology Clinic-Semmelweis Medical University

Budapest, Hungary

Location

Pecsi Tudomany Egyetem Klinikai kozpont Idegsebeszeti Klinica

Pécs, Hungary

Location

Ospedali Riuniti di Ancona

Ancona, Italy

Location

Ospedale san Raffaele

Milan, Italy

Location

AO S. Andrea Universita La Sapienza

Roma, Italy

Location

Azienda policlinico Umberto

Roma, Italy

Location

Centro medico ABC santa fe

Mexico City, Mexico

Location

Axis heilsa

Monterrey, Mexico

Location

Clinical research institute SC

Tlalnepantla, Mexico

Location

Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Oddzial w Gliwicach

Gliwice, Poland

Location

krakowski Szpital specjalistyczny il Jana Pawla II

Krakow, Poland

Location

Samodzielny publiczny szpital

Lublin, Poland

Location

Asan medical center

Seoul, South Korea

Location

Samsung medical center

Seoul, South Korea

Location

Seoul National university hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

gadopiclenolgadobenic acid

Results Point of Contact

Title
Jing Hao, MD, Global Head of Medical Affairs & Clinical Development
Organization
Guerbet
jing.hao@guerbet.com
+33 (0) 1 45 91 50 00

Study Officials

  • Martin BENDSZUS, MD

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2015

First Posted

December 17, 2015

Study Start

June 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

October 25, 2021

Results First Posted

May 8, 2019

Record last verified: 2021-10

Locations

HU(2)IT(4)ME(3)BE(2)CZ(1)US(10)PL(3)KR(3)