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

NCT06010173 | Completed Phase 3 Results

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

Brief Summary

GDX-44-014 - GDX-101 study was conducted in Japan including 2 cohorts (adult cohort for adult population and pediatric cohort for pediatric population), with different designs:

• The adult cohort had a prospective, multi-center, randomized, double-blind, controlled, and cross-over design.
• The pediatric cohort had a prospective, multi-center, non-randomized, open-label and single arm design. The primary objective was 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 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 (per patient) was based on 3 co-primary criteria (border delineation, internal morphology and degree of contrast enhancement) assessed by 3 independent off-site blinded readers. The IBR recorded 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 gadobutrol. Delineation of the lesion border was defined as the distinction of lesion from surrounding tissues, structures, or edema, and the detection of extent of the lesion. This criterion was assessed through the following scale: 1. = None 2. = Moderate 3. = Good 4. = Excellent: For this co-primary criterion, a mean of scores for each patient and for each reader was calculated and ranged from 1 to 4.

  At each MRI exam: the first MRI at Day 1 and the second MRI performed after a wash out period of 2 to 14 days (adult cohort)

• Lesion Visualization on Paired Images: Internal Morphology

  The lesion visualization criterion (per patient) was based on 3 co-primary criteria (border delineation, internal morphology and degree of contrast enhancement) assessed by 3 independent off-site blinded readers. The IBR recorded 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 gadobutrol. Internal morphology of the lesion included an identification of lesion architecture and the intra-lesion features such as necrosis, hemorrhage, and vascularity. This criterion was assessed through the following scale: 1. = Poor 2. = Moderate 3. = Good 4. = Excellent For this co-primary criterion "internal morphology", a mean of scores for each patient and for each reader was calculated and ranged from 1 to 4.

  At each MRI exam: the first MRI at Day 1 and the second MRI performed after a wash out period of 2 to 14 days (adult cohort)

• Lesion Visualization on Paired Images: Degree of Contrast Enhancement

  The lesion visualization criterion (per patient) was based on 3 co-primary criteria (border delineation, internal morphology and degree of contrast enhancement) assessed by 3 independent off-site blinded readers. The IBR recorded 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 gadobutrol. The criterion "degree of contrast enhancement" was a qualitative assessment (not based on signal intensity measurement) according to the following scale: 1. = No: no enhancement 2. = Moderate: weakly enhanced 3. = Good: clearly enhanced 4. = Excellent: clearly and brightly enhanced For each co-primary criterion, a mean of scores for each patient and for each reader was calculated and ranged from 1 to 4.

  At each MRI exam: the first MRI at Day 1 and the second MRI performed after a wash out period of 2 to 14 days (adult cohort)

Secondary Outcomes (3)

• Pediatric Cohort: Lesion Visualization on Paired Images Compared With Pre Images: Border Delineation

  At MRI exam, Day 1 (pediatric cohort)

• Pediatric Cohort: Lesion Visualization on Paired Images Compared With Pre Images: Internal Morphology

  At MRI exam, Day 1 (pediatric cohort)

• Pediatric Cohort: Lesion Visualization on Paired Images Compared With Pre Images: Degree of Contrast Enhancement

  At MRI exam, day 1 (pediatric cohort)

Study Arms (3)

Adult Cohort Arm 1: First MRI With Gadopiclenol and Second MRI With Gadobutrol

EXPERIMENTAL

Cross-over study. For each patient in this arm, he (she) performed the first contrast-enhanced MRI with gadopiclenol as contrast agent. After a washout period of 2-14 days, the patient performed the second contrast-enhanced MRI with gadobutrol as contrast agent. Gadopiclenol and gadobutrol were 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 might vary depending on scanned organ/region and age of patients.

Drug: Gadopiclenol; Drug: Comparator (gadobutrol)

Adult Cohort Arm 2: First MRI With Gadobutrol and Second MRI With Gadopiclenol

EXPERIMENTAL

Cross-over study. For each patient in this arm, he (she) performed the first contrast-enhanced MRI with gadobutrol as contrast agent. After a washout period of 2-14 days, the patient performed the second contrast-enhanced MRI with gadopiclenol as contrast agent. Gadobutrol and gadopiclenol were 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 might vary depending on scanned organ/region and age of patients.

Drug: Gadopiclenol; Drug: Comparator (gadobutrol)

Pediatric cohort: One MRI With Gadopiclenol

EXPERIMENTAL

Pediatric patients underwent one MRI examination with gadopiclenol. Gadopiclenol was 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

Interventions

Gadopiclenol DRUG

Dose/volume: Gadopiclenol administered was calculated based on patient's weight at the dose of 0.05 mmol/kg BW

Also known as: Elucirem/Vueway

Adult Cohort Arm 1: First MRI With Gadopiclenol and Second MRI With Gadobutrol; Adult Cohort Arm 2: First MRI With Gadobutrol and Second MRI With Gadopiclenol; Pediatric cohort: One MRI With Gadopiclenol

Comparator (gadobutrol) DRUG

Dose/volume of comparator: Gadobutrol administered was calculated based on patient's weight at the dose of 0.1 mmol/kg BW.

Also known as: Gadovist/Gadavist

Adult Cohort Arm 1: First MRI With Gadopiclenol and Second MRI With Gadobutrol; Adult Cohort Arm 2: First MRI With Gadobutrol and Second MRI With Gadopiclenol

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.
• Female or male adult patient having reached legal majority age of 18 years.
• 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.
• 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.
• Female or male pediatric patient from birth to 17 years. For patients aged from birth to 27 days, only term newborn infants were eligible.
• Patients might not have reached the age of 18 years at the MRI examination.
• 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.
• Patient with capacity of understanding who received age- and maturity-appropriate information and provided his/her assent to participate in the trial.
• 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:

• 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.
• 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 had to 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).
• Patient with acute disease that might rapidly evolve between the 2 MRI examinations
• Patient previously randomized in this trial.
• Patient expected/scheduled to have any treatment or medical procedure (e.g., chemotherapy, radiotherapy, biopsy, or surgery etc.) that might 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 could be included).
• 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.
• Patient with previously attributed IMP number in this trial.

Sponsors & Collaborators

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

Study Sites (27)

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

Shin-Kuki General Hospital

Saitama, 346-0021, 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; gadobutrol

Results Point of Contact

• Title: Frantz Hebert, Global Head of Clinical Development
• Organization: Guerbet

frantz.hebert@guerbet.com

+33 680249334

Study Officials

• Toshiaki Taoka, MD

  Nagoya University, JAPAN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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

Model Details: Randomized, double-blind, controlled, and cross-over design only for adult cohort with 2 arms. Non-randomized, open-label and single arm design for pediatric cohort.

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 24, 2023
• Study Start: July 21, 2023
• Primary Completion: May 6, 2025
• Study Completion: May 6, 2025
• Last Updated: June 25, 2026
• Results First Posted: June 25, 2026

Record last verified: 2026-06

Locations

JP (27)