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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001516-30 | EudraCT Number |
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This is a pharmacokinetics (PK), open-label, uncontrolled, multicenter phase II trial with age-staggered approach.
The primary objective is to evaluate the PK profile of gadopiclenol in plasma following single IV injection of 0.05 mmol/kg body weight (BW) in pediatric population aged from 2 to 17 years undergoing CNS contrast-enhanced MRI (CNS cohort).
A population PK approach and an age-down staggered approach will be used. Patients will be recruited into 3 predefined age groups: 12-17, 7-11 and 2-6 years. The inclusions will start with the older group (Adolescents, 12-17 years), followed by Preadolescents (7-11 years) and finally Young Children (2-6 years of age).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CNS Cohort 2-6 years | Experimental | Pediatric patients aged 2-6 years undergoing CNS contrast-enhanced MRI |
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| CNS Cohort 7-11 years | Experimental | Pediatric patients aged 7-11 years undergoing CNS contrast-enhanced MRI |
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| CNS Cohort 12-17 years | Experimental | Pediatric patients aged 12-17 years undergoing CNS contrast-enhanced MRI |
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| Body Cohort 2-6 years | Experimental | Pediatric patients aged 2-6 years undergoing contrast-enhanced MRI of other body organs (head and neck, thorax, abdomen, pelvis or musculoskeletal system) |
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| Body Cohort 7-11 years | Experimental | Pediatric patients aged 7-11 years undergoing contrast-enhanced MRI of other body organs (head and neck, thorax, abdomen, pelvis or musculoskeletal system) |
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| Body Cohort 12-17 years |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P03277 | Drug | A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Elimination Half-life | P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort. | 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours |
| Total Clearance | P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort. | 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours |
| Central Volume of Distribution | P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort. | 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours |
| Peripheral Volume of Distribution | P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort. | 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours |
| Area Under the Curve | P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort. | 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours |
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Inclusion Criteria:
To be included in the study, the patient had to meet all the following criteria:
Non-inclusion Criteria:
Patients could not be included in the study if they presented with one or more of the following non-inclusion criteria:
Patient planned for treatment or procedure (e.g., surgery) that would prevent obtaining the required blood samples or performing other trial procedures between the screening visit and up to 1 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 PK parameters,
Patient with acute or chronic renal insufficiency defined as estimated Glomerular Filtration Rate (eGFR) out of age-adjusted normal ranges (eGFR calculated with bedside Schwartz equation),
Patients referred for MR Angiography,
Patient with history of bleeding disorder,
Patient with known severe liver disease,
Patient with known cardiac disease (e.g., heart rhythm anomalies, long QT syndrome),
Patient with any clinically significant abnormal 12-lead ECG that in the Investigator's opinion would affect the safety evaluation or place the patient at risk,
Patient with electrolyte or fluid imbalance that at Investigator's judgment presents undue risk assessed within 1 month prior to gadopiclenol administration,
Patient undergoing a change in chemotherapy within 1 day prior to or 1 day after gadopiclenol administration,
Patient who received any other contrast agent for CT and/or MRI within 1 week prior to or 1 week after gadopiclenol administration,
Patient with contraindication for MRI such as iron metal implants (e.g., aneurysm clips, pacemaker),
Patient with history of anaphylactoid or anaphylactic reaction to any allergen including drugs,
Patient with history of hypersensitivity caused by any contrast media / agents (iodinated or gadolinium-based),
Patient with known contraindication(s) to the use of any GBCA,
Pregnant or breast-feeding female patient (female patient with childbearing potential [who experienced menarche] must have a negative urine pregnancy test within 24 hours prior to gadopiclenol administration and must be using medically approved contraception* if sexually active),
Patient with anticipated, current or past condition (medical, psychological, social or geographical) that would compromise the patient's safety or her/his ability to participate to the whole trial,
Patient unlikely to comply with the protocol, e.g., uncooperative attitude of parent(s) or legal guardian, inability to return for follow-up visits and unlikelihood of completing the trial,
Having participated in a clinical trial and having received any investigational product within 7 days prior to gadopiclenol administration or planned during the trial,
Patient previously included in this trial,
Patient related to the Investigator or any other trial staff or relative directly involved in the trial conduct.
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| Name | Affiliation | Role |
|---|---|---|
| Elżbieta Jurkiewicz, MD | Instytut Pomnik | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MHAT Central Onco Hospital Ltd | Plovdiv | Bulgaria | ||||
| Acibadem City Clinic Tokuda Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35318970 | Derived | Jurkiewicz E, Tsvetkova S, Grinberg A, Pasquiers B. Pharmacokinetics, Safety, and Efficacy of Gadopiclenol in Pediatric Patients Aged 2 to 17 Years. Invest Radiol. 2022 Aug 1;57(8):510-516. doi: 10.1097/RLI.0000000000000865. Epub 2022 Mar 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CNS & Body Cohorts 2-6 Years | Pediatric patients aged 2-6 years undergoing CNS or Body contrast-enhanced MRI P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection. |
| FG001 | CNS & Body Cohorts 7-11 Years |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 24, 2020 | Mar 29, 2022 |
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Pediatric patients aged 12-17 years undergoing contrast-enhanced MRI of other body organs (head and neck, thorax, abdomen, pelvis or musculoskeletal system) |
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| Simulated Concentrations 10 Minutes Post-injection | P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort. | 10 minutes post-injection |
| Simulated Concentrations 20 Minutes Post-injection | P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort. | 20 minutes post-injection |
| Simulated Concentrations 30 Minutes Post-injection | P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort. | 30 minutes post-injection |
| Sofia |
| Bulgaria |
| MHAT Dr. Stoyan Kirkovich | Stara Zagora | Bulgaria |
| Semmelweis Egyetem II. sz Gyermekgyogyaszati Klinika | Budapest | Hungary |
| Markhot Ferenc Oktatokorhaz es Rendelointezet | Eger | Hungary |
| B.-A.-Z. Megyei Korhaz Gyermek-Egeszsegugyi Kozpont | Miskolc | Hungary |
| Szpital Uniwersytecki nr 1 w Bydgoszczy im. dr Jurasza, Oddział Kliniczny Chirurgii Ogólnej i Onkologicznej Dzieci i Młodzieży | Bydgoszcz | Poland |
| Instytut Centrum Zdrowia Matki Polki | Lodz | Poland |
| Uniwersytecki Szpital Dziecięcy w Lublinie | Lublin | Poland |
| Klinika Chirurgii Dziecięcej | Rzeszów | Poland |
| Instytut "Pomnik -Centrum Zdrowia Dziecka" | Warsaw | Poland |
| Zakład Radiologii PediatrycznejSamodzielny Publ. Dziecięcy Szp. Kliniczny w Warszawie | Warsaw | Poland |
| II. Detská klinika SZU, Detská fakultná nemocnica s poliklinikou Banská Bystrica | Banská Bystrica | Slovakia |
| Klinika detí a dorastu JLF UK a UNM, Univerzitná nemocnica Martin | Martin | Slovakia |
| Faculty hospital Nitra, Clinic of neonates, children and adolescents | Nitra | Slovakia |
| Children's City Clinical Hospital | Dnipro | Ukraine |
Pediatric patients aged 7-11 years undergoing CNS or Body contrast-enhanced MRI P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection. |
| FG002 | CNS & Body Cohorts 12-17 Years | Pediatric patients aged 12-17 years undergoing CNS or Body contrast-enhanced MRI P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection. |
| COMPLETED |
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| NOT COMPLETED |
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All patients who received gadopiclenol administration and underwent CNS or Body MRI
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| ID | Title | Description |
|---|---|---|
| BG000 | CNS & Body Cohorts 2-6 Years | Pediatric patients aged 2-6 years undergoing CNS or Body contrast-enhanced MRI P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection. |
| BG001 | CNS & Body Cohorts 7-11 Years | Pediatric patients aged 7-11 years undergoing CNS or Body contrast-enhanced MRI P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection. |
| BG002 | CNS & Body Cohorts 12-17 Years | Pediatric patients aged 12-17 years undergoing CNS or Body contrast-enhanced MRI P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Elimination Half-life | P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort. | All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period | Posted | Median | Full Range | hours | 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours |
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| Primary | Total Clearance | P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort. | All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period | Posted | Median | Full Range | L/h/kg | 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours |
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| Primary | Central Volume of Distribution | P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort. | All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period | Posted | Median | Full Range | L/kg | 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours |
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| Primary | Peripheral Volume of Distribution | P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort. | All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period | Posted | Median | Full Range | L/kg | 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours |
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| Primary | Area Under the Curve | P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort. | All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period | Posted | Mean | Standard Deviation | mg.h/L | 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours |
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| Primary | Simulated Concentrations 10 Minutes Post-injection | P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort. | All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period | Posted | Mean | Standard Deviation | mg/L | 10 minutes post-injection |
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| Primary | Simulated Concentrations 20 Minutes Post-injection | P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort. | All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period | Posted | Mean | Standard Deviation | mg/L | 20 minutes post-injection |
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| Primary | Simulated Concentrations 30 Minutes Post-injection | P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort. | All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period | Posted | Mean | Standard Deviation | mg/L | 30 minutes post-injection |
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Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).
The Safety Set included all patients who had received at least one injection of gadopiclenol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CNS & Body Cohorts 2-6 Years | Pediatric patients aged 2-6 years undergoing CNS or Body contrast-enhanced MRI P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection. | 0 | 26 | 1 | 26 | 4 | 26 |
| EG001 | CNS & Body Cohorts 7-11 Years | Pediatric patients aged 7-11 years undergoing CNS or Body contrast-enhanced MRI P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection. | 0 | 23 | 0 | 23 | 6 | 23 |
| EG002 | CNS & Body Cohorts 12-17 Years | Pediatric patients aged 12-17 years undergoing CNS or Body contrast-enhanced MRI P03277: A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection. | 0 | 31 | 2 | 31 | 4 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Head injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Coma | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Condition aggravated | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Herpes virus infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Respiratory tract infection viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Tracheobronchitis mycoplasmal | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Condition aggravated | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Application site erythema | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Eosinophil count increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Long QT syndrome | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Glaucoma | Eye disorders | MedDRA 23.0 | Systematic Assessment |
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| Procedural Anxiety | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Head of Medical Affairs & Clinical Development | Guerbet | +33 (0) 1 45 91 50 00 | jing.hao@guerbet.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 27, 2021 | Mar 29, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000656634 | gadopiclenol |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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