search
Back to results

Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age

Primary Purpose

Central Nervous System Diseases, Pediatric Disorder, Body Indication

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Gadopiclenol
Sponsored by
Guerbet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Central Nervous System Diseases

Eligibility Criteria

undefined - 23 Months (Child)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

  1. Female or male pediatric patient aged from birth to 23 months of age inclusive (term neonates for all age groups or preterm infants after the neonatal period for groups 1 or 2). The neonatal period for preterm newborns is defined as the day of birth through the expected date of delivery plus 27 days. Term is defined as ≥37 completed weeks of amenorrhea,
  2. Patient with known or highly suspected abnormalities/ lesion(s) as detected by previous imaging examinations (including the fetal imaging, scheduled to undergo contrast-enhanced MRI of any body region including CNS [...]

Main Exclusion Criteria:

  1. Patient planned for treatment or procedure (e.g. surgery) that would prevent from obtaining the required blood samples or performing other trial procedures between the screening visit and up to one day after gadopiclenol administration,
  2. Patient undergoing treatment or procedure (e.g., diuretics, clinically significant blood loss or blood transfusion) preceding or subsequent to gadopiclenol administration that would alter gadopiclenol pharmacokinetic parameters,
  3. Patient with acute or chronic renal insufficiency defined as estimated Glomerular Filtration Rate (eGFR) out of age-adjusted normal value calculated based on bedside Schwartz equation, [...]

9. Patient undergoing a change in chemotherapy (product or dosage) within one day prior to or one day after gadopiclenol administration, 10. Patient who received or will receive any other contrast agent for CT and/or MRI within one week prior to or one week after gadopiclenol administration, 11. Patient with contraindication for MRI such as iron metal implants (e.g., aneurysm clips, pacemaker), 12. Patient with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents [...]

Sites / Locations

  • Cincinnatti Childrens HospitalRecruiting
  • Medical University of South CarolinaRecruiting
  • Multiprofile Hospital for Active Treatment Central Onco Hospital
  • Acibadem City Clinic Tokuda Hospital
  • Semmelweis EgyetemRecruiting
  • Országos Idegtudományi IntézetRecruiting
  • University of Debrecen Clinical Center Pediatric DepartmentRecruiting
  • Szpital Uniwersytecki nr 1 im. dr Antoniego JuraszaRecruiting
  • Instytut Centrum Zdrowia Matki PolkiRecruiting
  • Uniwersytecki Szpital DzieciecyRecruiting
  • Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi KrolowejRecruiting
  • Uniwersyteckie Centrum Kliniczne WarszawskiegoRecruiting
  • Instytut "Pomnik - Centrum Zdrowia Dziecka"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Age Group 1: patients aged 3 to 23 months

Age Group 2: patients aged 28 days to less than 3 months

Age Group 3: patients aged from birth to 27 days (term newborns)

Arm Description

One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.

One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.

One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.

Outcomes

Primary Outcome Measures

Simulated concentrations at 10 minutes post injection
Determined from population PK
Simulated concentrations at 20 minutes post injection
Determined from population PK
Simulated concentrations at 30 minutes post injection
Determined from population PK
Area Under the Curve
Determined from population PK
Elimination half-life
Determined from population PK
Total clearance
Determined from population PK
Volume of distribution
Determined from population PK

Secondary Outcome Measures

Full Information

First Posted
October 18, 2022
Last Updated
September 30, 2023
Sponsor
Guerbet
search

1. Study Identification

Unique Protocol Identification Number
NCT05590884
Brief Title
Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age
Official Title
Gadopiclenol Pharmacokinetics, Safety and Efficacy in Pediatric Patients < 2 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guerbet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This Phase II open-label, uncontrolled, multicenter trial is designed to investigate the pharmacokinetic (PK) profile of gadopiclenol in plasma, in pediatric patients aged up to 23 months inclusive (term neonates or preterm infants after the neonatal period), using a population PK approach. Primary objective is to evaluate the PK profile of gadopiclenol in plasma following single intravenous injection of 0.05 mmol/kg body weight (BW) in pediatric population aged up to 23 months (inclusive) scheduled for a contrast-enhanced MRI examination of any body region including central nervous system (CNS).
Detailed Description
Inclusion will be performed using an age-down staggered approach. Three age groups will be defined: Group 1: patients aged 3 to 23 months (inclusive) Group 2: patients aged 28 days to less than 3 months; Group 3: patients aged from birth to 27 days (term newborns). The inclusions will start with the oldest patients (Group 1) and end with the youngest patients (Group 3). A total of 3 blood samples per patient will be taken post-injection for PK analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Diseases, Pediatric Disorder, Body Indication

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Age Group 1: patients aged 3 to 23 months
Arm Type
Experimental
Arm Description
One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.
Arm Title
Age Group 2: patients aged 28 days to less than 3 months
Arm Type
Experimental
Arm Description
One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.
Arm Title
Age Group 3: patients aged from birth to 27 days (term newborns)
Arm Type
Experimental
Arm Description
One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.
Intervention Type
Drug
Intervention Name(s)
Gadopiclenol
Other Intervention Name(s)
Elucirem
Intervention Description
Patients will receive a single dose of gadopiclenol calculated according to their BW on the day of MRI examination. Gadopiclenol will be administered at a dose of 0.05 mmol/kg BW (0.1 mL/kg BW).
Primary Outcome Measure Information:
Title
Simulated concentrations at 10 minutes post injection
Description
Determined from population PK
Time Frame
Concentration is simulated at 10 minutes post injection
Title
Simulated concentrations at 20 minutes post injection
Description
Determined from population PK
Time Frame
Concentration is simulated at 20 minutes post injection
Title
Simulated concentrations at 30 minutes post injection
Description
Determined from population PK
Time Frame
Concentration is simulated at 30 minutes post injection
Title
Area Under the Curve
Description
Determined from population PK
Time Frame
A total of 3 blood samples per patient will be taken post-injection for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Title
Elimination half-life
Description
Determined from population PK
Time Frame
A total of 3 blood samples per patient will be taken post-injection for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Title
Total clearance
Description
Determined from population PK
Time Frame
A total of 3 blood samples per patient will be taken post-injection for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).
Title
Volume of distribution
Description
Determined from population PK
Time Frame
A total of 3 blood samples per patient will be taken post-injection for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours).

10. Eligibility

Sex
All
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Female or male pediatric patient aged from birth to 23 months of age inclusive (term neonates for all age groups or preterm infants after the neonatal period for groups 1 or 2). The neonatal period for preterm newborns is defined as the day of birth through the expected date of delivery plus 27 days. Term is defined as ≥37 completed weeks of amenorrhea, Patient with known or highly suspected abnormalities/ lesion(s) as detected by previous imaging examinations (including the fetal imaging, scheduled to undergo contrast-enhanced MRI of any body region including CNS [...] Main Exclusion Criteria: Patient planned for treatment or procedure (e.g. surgery) that would prevent from obtaining the required blood samples or performing other trial procedures between the screening visit and up to one day after gadopiclenol administration, Patient undergoing treatment or procedure (e.g., diuretics, clinically significant blood loss or blood transfusion) preceding or subsequent to gadopiclenol administration that would alter gadopiclenol pharmacokinetic parameters, Patient with acute or chronic renal insufficiency defined as estimated Glomerular Filtration Rate (eGFR) out of age-adjusted normal value calculated based on bedside Schwartz equation, [...] 9. Patient undergoing a change in chemotherapy (product or dosage) within one day prior to or one day after gadopiclenol administration, 10. Patient who received or will receive any other contrast agent for CT and/or MRI within one week prior to or one week after gadopiclenol administration, 11. Patient with contraindication for MRI such as iron metal implants (e.g., aneurysm clips, pacemaker), 12. Patient with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents [...]
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Hao, MD
Phone
+33647121957
Email
jing.hao@guerbet.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna R Roberts, MD
Organizational Affiliation
Medical University of South Carolina, Division of Neuroradiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnatti Childrens Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Dillman, MD
Phone
513-584-2146
Email
jonathan.dillman@cchmc.org
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-8908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin R CHETTA, MD
Phone
832-498-3810
Email
chettaj@musc.edu
Facility Name
Multiprofile Hospital for Active Treatment Central Onco Hospital
City
Plovdiv
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silviya Tsvetkova-Trichkova
Phone
+359 882 446 060
Email
sts2001@abv.bg
Facility Name
Acibadem City Clinic Tokuda Hospital
City
Sofia
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Galina Kirova, MD
Phone
+359 2 403 4000
Email
gal.kirova@gmail.com
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miklós Garami, MD
Phone
+3612151381
Email
miklos.garami@gmail.com
Facility Name
Országos Idegtudományi Intézet
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Balázs Markia, MD
Phone
+36306894230
Email
markiabalazs@gmail.com
Facility Name
University of Debrecen Clinical Center Pediatric Department
City
Debrecen
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Bessenyei, MD
Phone
+3652255335
Email
besmoni@gmail.com
Facility Name
Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza
City
Bydgoszcz
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Przemysław Galazka, MD
Phone
+48 52 585 40 15
Email
galazkaprzemek@hotmail.com
Facility Name
Instytut Centrum Zdrowia Matki Polki
City
Lodz
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Grzelak, MD
Phone
+48 42 271 15 71
Email
piotr.grzelak@iczmp.edu.pl
Facility Name
Uniwersytecki Szpital Dzieciecy
City
Lublin
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanda Furmaga-Jabłonska
Phone
+48 81 71 85 371
Email
wanda.furmaga-jablonska@umlub.pl
Facility Name
Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej
City
Rzeszów
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renata Jonczyk, MD
Phone
+48 17 866 42 95
Email
reniajonczyk@op.pl
Facility Name
Uniwersyteckie Centrum Kliniczne Warszawskiego
City
Warszawa
ZIP/Postal Code
02-091
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariusz Furmanek, MD
Phone
+48 22 317 92 81
Email
mariusz.furmanek@uckwum.pl
Facility Name
Instytut "Pomnik - Centrum Zdrowia Dziecka"
City
Warszawa
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elzbieta Jurkiewicz, MD
Phone
+48 22 815 12 94

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age

We'll reach out to this number within 24 hrs