Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children

NCT06010173 | Completed Phase 3

• 1 other identifier: GDX-44-014 - GDX-101
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 27

Brief Summary

This trial conducted in Japan includes 2 different cohorts of patients: adult patients and pediatric patients with two different designs.

• The cohort of adult patients has a prospective, multi-center, randomized, double-blind, controlled, and cross-over design.
• The cohort of pediatric patients has a prospective, multi-center, non-randomized, open-label and single arm design. Primary objective to demonstrate the non-inferiority of gadopiclenol-enhanced MRI at 0.05 mmol/kg body weight (BW) compared to gadobutrol-enhanced MRI at 0.1 mmol/kg BW in terms of lesion visualization is applicable for adult patients referred for contrast-enhanced MRI of Central Nervous System (CNS) or Body regions.

Conditions

Lesion in Body Region; CNS Lesion

Outcome Measures

Primary Outcomes (3)

• Lesion visualization on Paired Images: border delineation

  The lesion visualization criterion is based on 3 co-primary criteria rated on a scale from 1 to 4 : border delineation, internal morphology and degree of contrast enhancement assessed by 3 independent off-site blinded readers (IBR). The IBR will record each of the 3 co-primary criteria for up to 10 largest and most enhancing lesions on Paired (pre+post) images performed with gadopiclenol and Paired (pre+post) images performed with comparator. Delineation of the lesion border is defined as the distinction of lesion from surrounding tissues, structures, or edema, and the detection of extent of the lesion. This criterion will be assessed through the following scale: 1. = None 2. = Moderate 3. = Good 4. = Excellent For each co-primary criterion, a mean of scores will be calculated and will range from 1 to 4.

  MRI central reading within 2 days to 2 weeks after each MRI exam

• Lesion visualization on Paired Images: internal morphology

  The lesion visualization criterion is based on 3 co-primary criteria rated on a scale from 1 (Poor) to 4 (Excellent): border delineation, internal morphology and degree of contrast enhancement assessed by 3 independent off-site blinded readers (IBR). The IBR will record each of the 3 co-primary criteria for up to 10 largest and most enhancing lesions on Paired (pre+post) images performed with gadopiclenol and Paired (pre+post) images performed with comparator. Internal morphology of the lesion includes an identification of lesion architecture and the intra-lesion features such as necrosis, hemorrhage, and vascularity. This criterion will be assessed through the following scale: 1. = Poor 2. = Moderate 3. = Good 4. = Excellent For each co-primary criterion, a mean of scores will be calculated and will range from 1 to 4.

  MRI central reading within 2 days to 2 weeks after each MRI exam

• Lesion visualization on Paired Images: degree of contrast enhancement

  The lesion visualization criterion is based on 3 co-primary criteria rated on a scale from 1 (Poor) to 4 (Excellent): border delineation, internal morphology and degree of contrast enhancement assessed by 3 independent off-site blinded readers (IBR). The IBR will record each of the 3 co-primary criteria for up to 10 largest and most enhancing lesions on Paired (pre+post) images performed with gadopiclenol and Paired (pre+post) images performed with comparator. This criterion will be a qualitative assessment (not based on signal intensity measurement) according to the following scale: 1. = No 2. = Moderate 3. = Good 4. = Excellent For each co-primary criterion, a mean of scores will be calculated and will range from 1 to 4.

  MRI central reading within 2 days to 2 weeks after each MRI exam

Study Arms (3)

Adult cohort

EXPERIMENTAL

Each of 2 MRI visits will consist of gadopiclenol injection or comparator injection and MRI procedure (administered in a randomized, blinded and cross-over design). Gadopiclenol and comparator will be injected as a single intravenous (IV) bolus injection at a recommended rate of approximately 2 mL/second followed by a 0.9% saline flush via manual injection or power injector. The injection rate should be identical for both products and may vary depending on scanned organ/region and age of patients.

Drug: Gadopiclenol; Drug: Comparator

Pediatric cohort

EXPERIMENTAL

Pediatric patients will undergo one MRI examination with gadopiclenol (V2). Gadopiclenol will be injected in a single intravenous (IV) bolus injection at a recommended rate of approximately 2 mL/second followed by a 0.9% saline flush via manual injection or power injector.

Drug: Gadopiclenol

Pediatric PK cohort

EXPERIMENTAL

Pediatric patients will undergo one MRI examination with gadopiclenol (V2). Gadopiclenol will be injected in a single intravenous (IV) bolus injection at a recommended rate of approximately 2 mL/second followed by a 0.9% saline flush via manual injection or power injector. In addition a total of 3 blood samples per patient will be taken post-injection for PK analysis over the period of 8 hours post-injection.

Drug: Gadopiclenol

Interventions

Gadopiclenol DRUG

Dose/volume of gadopiclenol to be administered will be calculated based on patient's weight at the dose of 0.05 mmol/kg BW

Adult cohort; Pediatric PK cohort; Pediatric cohort

Comparator DRUG

Dose/volume of comparator to be administered will be calculated based on patient's weight at the dose of 0.1 mmol/kg BW

Adult cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All Patient presenting with known or suspected enhancing abnormality(ies) and/or lesion(s) in CNS or in at least one body region among head \& neck, thorax (e.g. breast), abdomen (e.g. liver, pancreas and kidney), pelvis (e.g. uterus, ovary and prostate) and musculoskeletal (e.g. extremities) based on a previous imaging procedure performed within 12 months prior to Informed Consent Form (ICF) signature.
• All If the patient was treated (either with radiation, surgery, biopsy, or other relevant treatments) between previous imaging evaluation and trial MRI, there should still be a high suspicion of remaining enhancing abnormality(ies) and/or lesion(s) based on available clinical information.
• All Patient able and willing to participate in the trial.
• All Patient affiliated to national health insurance according to local regulatory requirements.
• A Female or male adult patient having reached legal majority age of 18 years.
• A Patient scheduled for a contrast-enhanced MRI examination of CNS or a Body region for clinical reasons and agreeing to have a second contrast-enhanced MRI examination for the purpose of the trial.
• A Patient having read the information and having provided his/her consent to participate in writing by dating and signing the informed consent prior to any trial related procedure being conducted.
• P Female or male pediatric patient from birth to 17 years. For patients aged from birth to 27 days, only term newborn infants are eligible.
• Patients may not have reached the age of 18 years at the MRI examination.
• P Patient whose parent(s) or legal guardian (where applicable) having read the information provided his/her/their consent to patient's participation in writing by dating and signing the informed consent prior to any trial related procedure being conducted.
• P Patient with capacity of understanding who received age- and maturity-appropriate information and provided his/her assent to participate in the trial.
• P-PK Patient and his/her parent(s) or legal guardian (where applicable) having read the information and provided his/her consent in writing by dating and signing the Informed Consent form or respectively in the patient assent form their consent to participate in the PK analyses.

You may not qualify if:

• bis.All Patient referred for contrast-enhanced cardiac MRI as primary examination (e.g. imaging protocol requiring stress or more than a single injection of gadolinium contrast agent) except for late-enhancement cardiac imaging.
• All Patient having received any investigational medicinal product (IMP) within 7 days prior to trial entry or scheduled to receive any investigational treatment during the trial.
• All Patient presenting with any contraindication to MRI examinations. 4.All Patient having received any contrast agent (for MRI or CT) within 3 days (or 7 days for patients \<1 year old) prior to trial product administration or scheduled to receive any contrast agent during the trial or within 24 hours after the last trial product administration (or 7 days after for patients \<1 year old).
• All 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 in the trial in the Investigator's opinion.
• All Female patient of childbearing potential with a positive urine pregnancy test done within 1 day prior to each contrast agent administration and not able / not willing to use highly effective birth-controlled method during the trial duration.
• Female must have effective medically approved contraception until the last trial visit, if of childbearing potential or with amenorrhea for less than 12 months or must be surgically sterilized or post-menopausal (\> 2 years amenorrhea).
• All Patient unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits and/or unlikelihood of completing the trial.
• All Patient related to the Investigator or any other trial staff or relative directly involved in the trial conduct.
• All Patient with known contra-indication(s) to the use or with known sensitivity to one of the products under investigation or to other gadolinium based contrast agents (GBCAs) (such as hypersensitivity, post contrast acute kidney injury).
• A Patient with acute disease that may rapidly evolve between the 2 MRI examinations
• A Patient previously randomized in this trial.
• A Patient expected/scheduled to have any treatment or medical procedure (e.g., chemotherapy, radiotherapy, biopsy, or surgery etc.) that may impact the aspects of the imaged lesions between the 2 MRI examinations. (Patients under corticosteroids and/or maintenance chemotherapy with a stable dose at the time of screening visit and throughout the trial can be included).
• bis.A Patient presenting an estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m\^2 (based on Japanese coefficient-modified CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration) formula) assessed within 1 week prior to the first contrast agent administration.
• P Patient with previously attributed IMP number in this trial.
• P Patient with known long QT syndrome.

Sponsors & Collaborators

• Guerbet: lead
• Bracco Imaging S.p.A.: collaborator

Study Sites (27)

Shin-Kuki General Hospital

Saitama, Saitama, 346-0021, Japan

Location

Meitetsu Hospital

Aichi, 451-8511, Japan

Location

Fukuoka University Hospital

Fukuoka, 814-0180, Japan

Location

Gifu University Hospital

Gifu, 501-1194, Japan

Location

Gunma University Hospital

Gunma, 371-8511, Japan

Location

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, 730-8518, Japan

Location

Nakamura Memorial Hospital

Hokkaido, 060-8570, Japan

Location

National Hospital Organization Shikoku Medical Center for Children and Adults

Kagawa, 765-8507, Japan

Location

Kanagawa Children's Medical Center

Kanagawa, 232-0066, Japan

Location

Kobe City Medical Center General Hospital

Kobe, 650-0047, Japan

Location

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Kyoto City Hospital

Kyoto, 604-8845, Japan

Location

Tohoku University Hospital

Miyagi, 980-8574, Japan

Location

Nara Medical University Hospital

Nara, 634-8522, Japan

Location

Kawasaki Medical School Hospital

Okayama, 701-0192, Japan

Location

Osaka Metropolitan University Hospital

Osaka, 545-8586, Japan

Location

Tominaga Hospital

Osaka, 556-0017, Japan

Location

Saitama Prefectural Children's Medical Center

Saitama, 330-8777, Japan

Location

Shizuoka General Hospital

Shizuoka, 420-8527, Japan

Location

Hamamatsu University Hospital

Shizuoka, 431-3192, Japan

Location

Jichi Medical University Hospital

Tochigi, 329-0498, Japan

Location

Tokyo Shinagawa Hospital

Tokyo, 140-8522, Japan

Location

Toho University Omori Medical Center

Tokyo, 143-8541, Japan

Location

National Center for Child Health and Development

Tokyo, 157-8535, Japan

Location

Tokyo Metropolitan Children's Medical Center

Tokyo, 183-8561, Japan

Location

Kurobe City Hospital

Toyama, 938-8502, Japan

Location

Yamaguchi University Hospital

Yamaguchi, 755-8505, Japan

Location

MeSH Terms

Interventions

gadopiclenol

Study Officials

• Toshiaki Taoka, MD

  Nagoya University, JAPAN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 24, 2023
• Study Start: July 21, 2023
• Primary Completion: March 26, 2025
• Study Completion: March 26, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (27)