NCT05590884 - Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 21, 2022

Primary Completion Date

September 30, 2024

Study Completion Date

September 30, 2024

Conditions

Central Nervous System DiseasesPediatric DisorderBody Indication

Interventions

DRUG

Gadopiclenol

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).

Trial Locations (11)

1094

Semmelweis Egyetem, Budapest

45229

Cincinnatti Childrens Hospital, Cincinnati

29425-8908

Medical University of South Carolina, Charleston

Unknown

Országos Idegtudományi Intézet, Budapest

University of Debrecen Clinical Center Pediatric Department, Debrecen

Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza, Bydgoszcz

Instytut Centrum Zdrowia Matki Polki, Lodz

Uniwersytecki Szpital Dzieciecy, Lublin

Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej, Rzeszów

"Instytut Pomnik - Centrum Zdrowia Dziecka", Warsaw

02-091

Uniwersyteckie Centrum Kliniczne Warszawskiego, Warsaw