Pharmacokinetics, Safety and Efficacy of P03277 in Pediatric Patients Undergoing Central Nervous System Contrast-enhanced MRI

NCT ID: NCT03749252

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-06
• Study Completion Date: 2020-08-10

Brief Summary

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).

Detailed Description

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).

Conditions

Central Nervous System Indication; Pediatric Patients; Body Indication

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CNS Cohort 2-6 years

Pediatric patients aged 2-6 years undergoing CNS contrast-enhanced MRI

Group Type: EXPERIMENTAL

P03277

Intervention Type: 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.

CNS Cohort 7-11 years

Pediatric patients aged 7-11 years undergoing CNS contrast-enhanced MRI

Group Type: EXPERIMENTAL

P03277

Intervention Type: 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.

CNS Cohort 12-17 years

Pediatric patients aged 12-17 years undergoing CNS contrast-enhanced MRI

Group Type: EXPERIMENTAL

P03277

Intervention Type: 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.

Body Cohort 2-6 years

Pediatric patients aged 2-6 years undergoing contrast-enhanced MRI of other body organs (head and neck, thorax, abdomen, pelvis or musculoskeletal system)

Group Type: EXPERIMENTAL

P03277

Intervention Type: 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.

Body Cohort 7-11 years

Pediatric patients aged 7-11 years undergoing contrast-enhanced MRI of other body organs (head and neck, thorax, abdomen, pelvis or musculoskeletal system)

Group Type: EXPERIMENTAL

P03277

Intervention Type: 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.

Body Cohort 12-17 years

Pediatric patients aged 12-17 years undergoing contrast-enhanced MRI of other body organs (head and neck, thorax, abdomen, pelvis or musculoskeletal system)

Group Type: EXPERIMENTAL

P03277

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

gadopiclenol

Eligibility Criteria

Inclusion Criteria

To be included in the study, the patient had to meet all the following criteria:

1. Female or male pediatric patient aged 2 to 17 years,

2. Patient with known or suspected lesion(s) scheduled to undergo routine contrast-enhanced MRI of CNS or of other organs including at least one organ among head and neck, thorax, abdomen, pelvis or musculoskeletal system (including extremities),

3. Patient whose parent(s) or legal guardian having read the information, provided their consent to patient's participation in writing by dating and signing the informed consent prior to any trial related procedure being conducted,

4. Patient with capacity of understanding who received age- and maturity-appropriate information and provided his/her assent to participate in the trial (as required by national regulations),

5. Patient affiliated to national health insurance according to local regulatory requirements.

1. 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,

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 PK parameters,

3. 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),

4. Patients referred for MR Angiography,

5. Patient with history of bleeding disorder,

6. Patient with known severe liver disease,

7. Patient with known cardiac disease (e.g., heart rhythm anomalies, long QT syndrome),

8. 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,

9. Patient with electrolyte or fluid imbalance that at Investigator's judgment presents undue risk assessed within 1 month prior to gadopiclenol administration,

10. Patient undergoing a change in chemotherapy within 1 day prior to or 1 day after gadopiclenol administration,

11. Patient who received any other contrast agent for CT and/or MRI within 1 week prior to or 1 week after gadopiclenol administration,

12. Patient with contraindication for MRI such as iron metal implants (e.g., aneurysm clips, pacemaker),

13. Patient with history of anaphylactoid or anaphylactic reaction to any allergen including drugs,

14. Patient with history of hypersensitivity caused by any contrast media / agents (iodinated or gadolinium-based),

15. Patient with known contraindication(s) to the use of any GBCA,

16. 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),

17. 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,

18. 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,

19. Having participated in a clinical trial and having received any investigational product within 7 days prior to gadopiclenol administration or planned during the trial,

20. Patient previously included in this trial,

21. Patient related to the Investigator or any other trial staff or relative directly involved in the trial conduct.

• medically approved contraception methods include: female sterilization, use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception, placement of an Intrauterine Device (IUD) or Intrauterine System (IUS), barrier methods of contraception (condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository).

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guerbet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elżbieta Jurkiewicz, MD

Role: PRINCIPAL_INVESTIGATOR

Instytut Pomnik

Locations

MHAT Central Onco Hospital Ltd

Plovdiv, , Bulgaria

Acibadem City Clinic Tokuda Hospital

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

Countries

Bulgaria; Hungary; Poland; Slovakia; Ukraine

References

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.

Reference Type: DERIVED

PMID: 35318970 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018-001516-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GDX-44-007

Identifier Type: -

Identifier Source: org_study_id