Lesion in Body RegionPhase 3NCT06010173
Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children
A Phase 3 study testing Gadopiclenol and Comparator (gadobutrol) in people with Lesion in Body Region and CNS Lesion, run by Guerbet at 27 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lesion in Body Region, CNS Lesion
- What is being tested?
- Gadopiclenol and Comparator (gadobutrol)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 27 sitesJapan
- Study dates
- 21 Jul 2023to 6 May 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- Non-inclusion criteria for all patients:
- 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.
Show all 20Show fewer
- 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).
- Non-inclusion criteria for adult patients:
- 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.
- Non-inclusion criteria for pediatric patients:
- Patient with previously attributed IMP number in this trial.
- Patient with known long QT syndrome.
- Patient presenting an estimated Glomerular Filtration Rate (eGFR) outside age-adjusted normal ranges (based on bedside Schwartz equation) assessed within one week prior to contrast agent administration.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Japan27 sites
Meitetsu Hospital
Aichi, 451-8511
Fukuoka University Hospital
Fukuoka, 814-0180
Gifu University Hospital
Gifu, 501-1194
Gunma University Hospital
Gunma, 371-8511
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518
Nakamura Memorial Hospital
Hokkaido, 060-8570
National Hospital Organization Shikoku Medical Center for Children and Adults
Kagawa, 765-8507
Kanagawa Children's Medical Center
Kanagawa, 232-0066
Kobe City Medical Center General Hospital
Kobe, 650-0047
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, 602-8566
Kyoto City Hospital
Kyoto, 604-8845
Tohoku University Hospital
Miyagi, 980-8574
Nara Medical University Hospital
Nara, 634-8522
Kawasaki Medical School Hospital
Okayama, 701-0192
Osaka Metropolitan University Hospital
Osaka, 545-8586
Tominaga Hospital
Osaka, 556-0017
Saitama Prefectural Children's Medical Center
Saitama, 330-8777
Shin-Kuki General Hospital
Saitama, 346-0021
Shizuoka General Hospital
Shizuoka, 420-8527
Hamamatsu University Hospital
Shizuoka, 431-3192
Jichi Medical University Hospital
Tochigi, 329-0498
Tokyo Shinagawa Hospital
Tokyo, 140-8522
Toho University Omori Medical Center
Tokyo, 143-8541
National Center for Child Health and Development
Tokyo, 157-8535
Tokyo Metropolitan Children's Medical Center
Tokyo, 183-8561
Kurobe City Hospital
Toyama, 938-8502
Yamaguchi University Hospital
Yamaguchi, 755-8505
About this study
Official title: Efficacy and Safety of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children
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.
Read the detailed description
Adult cohort:
The trial included a maximum of 5 visits and the record of patient's diagnosis as standard of truth:
- One screening visit (V1) up to 7 days prior to the imaging visit (V2) (V1 could be done on the same day as V2 if all the inclusion/non-inclusion criteria were met).
- Two sequential imaging visits (V2 and V4, minimum interval 2 days and up to 14 days): each visit consisted of gadopiclenol injection or comparator injection and MRI procedure.
- Two safety visits (V3 and V5): 1 day after each injection and MRI examination.
Pediatric cohort:
The inclusions was divided into 4 age groups: patients from birth to 23 months of age inclusive, patients from 2 to 6 years, patients from 7 to 11 years and patients from 12 to 17 years. The recruitment in the 3 older groups of pediatric patients could be conducted in parallel with adult patients' enrolment. The decision to start the inclusion in the group of patients aged from birth to 23 months was taken by the Trial Safety Review Board (TSRB).
The trial included a maximum of 3 visits and the record of patient's diagnosis as standard of truth:
- One screening visit (V1) up to 7 days prior to the imaging visit (V2) (V1 could be done on the same day as V2 if all the inclusion/non-inclusion criteria were met).
- One imaging visit (V2) consisted of gadopiclenol injection and MRI procedure.
- pharmacokinetics (PK) group: Blood sampling for PK started after gadopiclenol injection according to defined blood sampling schedule and took up to 8 hours.
- One safety visit (V3): 1 day after gadopiclenol injection and MRI examination.
All Patients:
Images were assessed off-site in a centralized manner.
Pediatric group for pharmacokinetics (PK) analysis :
Up to 24 patients of the pediatric cohort would be included in gadopiclenol PK profile assessment.
The approach implemented for PK analyses allowed sparse blood sampling only and was selected to minimize the clinical burden to children.
All cohorts :
During the trial, the safety of the patients was monitored and assessed based on the reporting of adverse events (AEs), including vital signs, ECG for pediatric patients and clinical laboratory parameters (blood samples).
- Conditions
- Lesion in Body Region, CNS Lesion
- Being tested
- Gadopiclenol, Comparator (gadobutrol)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GadopiclenolDrug
Also called Elucirem/Vueway
Dose/volume: Gadopiclenol administered was calculated based on patient's weight at the dose of 0.05 mmol/kg BW
Comparator (gadobutrol)Drug
Also called Gadovist/Gadavist
Dose/volume of comparator: Gadobutrol administered was calculated based on patient's weight at the dose of 0.1 mmol/kg BW.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Gadopiclenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- = None
- = Moderate
- = Good
- = 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.
Measured: 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:
- = Poor
- = Moderate
- = Good
- = 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.
Measured: 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:
- = No: no enhancement
- = Moderate: weakly enhanced
- = Good: clearly enhanced
- = 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.
Measured: 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
The lesion visualization criterion based on 3 co-criteria: border delineation, internal morphology and degree of contrast enhancement assessed on the images acquired during the MRI performed with gadopiclenol assessed by 3 independent off-site blinded readers (IBR).
The IBR recorded each of the 3 co-criteria for up to 10 largest and most enhancing lesions on Paired (pre+post) images and Pre images performed with gadopiclenol as contrast agent.
Definitions of each co-criteria and score calculation were provided in the section for primary outcome measure.
Measured: At MRI exam, Day 1 (pediatric cohort)
Pediatric Cohort: Lesion Visualization on Paired Images Compared With Pre Images: Internal Morphology
The lesion visualization criterion based on 3 co-criteria: border delineation, internal morphology and degree of contrast enhancement assessed on the images acquired during the MRI performed with gadopiclenol assessed by 3 independent off-site blinded readers (IBR).
The IBR recorded each of the 3 co-criteria for up to 10 largest and most enhancing lesions on Paired (pre+post) images and Pre images performed with gadopiclenol.
Definitions of each co-criteria and score calculation were provided in the section for primary outcome measure.
Measured: At MRI exam, Day 1 (pediatric cohort)
Pediatric Cohort: Lesion Visualization on Paired Images Compared With Pre Images: Degree of Contrast Enhancement
The lesion visualization criterion based on 3 co-criteria: border delineation, internal morphology and degree of contrast enhancement assessed on the images acquired during the MRI performed with gadopiclenol assessed by 3 independent off-site blinded readers (IBR).
The IBR recorded each of the 3 co-criteria for up to 10 largest and most enhancing lesions on Paired (pre+post) images and Pre images performed with gadopiclenol.
Definitions of each co-criteria and score calculation were provided in the section for primary outcome measure.
Measured: At MRI exam, day 1 (pediatric cohort)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start21 Jul 2023
- Primary completion6 May 2025
- Study completion6 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lesion in Body RegionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bracco Imaging S.p.A.
- Responsible party
- Sponsor
- Investigators
- Toshiaki Taoka, MD, Principal investigator, Nagoya University, JAPAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010173
- Sponsor's protocol ID
- GDX-44-014 - GDX-101
- Status last verified
- Jun 2026
- First submitted
- 28 Jul 2023
- Last updated
- 25 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children
- ClinicalTrials.gov ID
- NCT06010173
- Acronym / sponsor ID
- GDX-44-014 - GDX-101
- Conditions
- Lesion in Body Region, CNS Lesion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Collaborators
- Bracco Imaging S.p.A.
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 6 May 2025 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Posted 25 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Adult cohort:
The trial included a maximum of 5 visits and the record of patient's diagnosis as standard of truth:
- One screening visit (V1) up to 7 days prior to the imaging visit (V2) (V1 could be done on the same day as V2 if all the inclusion/non-inclusion criteria were met).
- Two sequential imaging visits (V2 and V4, minimum interval 2 days and up to 14 days): each visit consisted of gadopiclenol injection or comparator injection and MRI procedure.
- Two safety visits (V3 and V5): 1 day after each injection and MRI examination.
Pediatric cohort:
The inclusions was divided into 4 age groups: patients from birth to 23 months of age inclusive, patients from 2 to 6 years, patients from 7 to 11 years and patients from 12 to 17 years. The recruitment in the 3 older groups of pediatric patients could be conducted in parallel with adult patients' enrolment. The decision to start the inclusion in the group of patients aged from birth to 23 months was taken by the Trial Safety Review Board (TSRB).
The trial included a maximum of 3 visits and the record of patient's diagnosis as standard of truth:
- One screening visit (V1) up to 7 days prior to the imaging visit (V2) (V1 could be done on the same day as V2 if all the inclusion/non-inclusion criteria were met).
- One imaging visit (V2) consisted of gadopiclenol injection and MRI procedure.
- pharmacokinetics (PK) group: Blood sampling for PK started after gadopiclenol injection according to defined blood sampling schedule and took up to 8 hours.
- One safety visit (V3): 1 day after gadopiclenol injection and MRI examination.
All Patients:
Images were assessed off-site in a centralized manner.
Pediatric group for pharmacokinetics (PK) analysis :
Up to 24 patients of the pediatric cohort would be included in gadopiclenol PK profile assessment.
The approach implemented for PK analyses allowed sparse blood sampling only and was selected to minimize the clinical burden to children.
All cohorts :
During the trial, the safety of the patients was monitored and assessed based on the reporting of adverse events (AEs), including vital signs, ECG for pediatric patients and clinical laboratory parameters (blood samples).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Adult Cohort Arm 1: First MRI With Gadopiclenol and Second MRI With Gadobutrol | Experimental | Drug: Gadopiclenol, Drug: Comparator (gadobutrol)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. |
| Adult Cohort Arm 2: First MRI With Gadobutrol and Second MRI With Gadopiclenol | Experimental | Drug: Gadopiclenol, Drug: Comparator (gadobutrol)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. |
| Pediatric cohort: One MRI With Gadopiclenol | Experimental | Drug: GadopiclenolPediatric 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Patients might not have reached the age of 18 years at the MRI examination.
Key exclusion criteria (20 listed)
- Non-inclusion criteria for all patients:
- 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).
- Non-inclusion criteria for adult patients:
- Non-inclusion criteria for pediatric patients:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GadopiclenolAlso: Elucirem/VuewayDose/volume: Gadopiclenol administered was calculated based on patient's weight at the dose of 0.05 mmol/kg BW | Drug | 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)Also: Gadovist/GadavistDose/volume of comparator: Gadobutrol administered was calculated based on patient's weight at the dose of 0.1 mmol/kg BW. | Drug | 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 |
Primary outcome
Lesion Visualization on Paired Images: Border Delineation
Time frame: 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)
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.
Lesion Visualization on Paired Images: Internal Morphology
Time frame: 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)
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.
Lesion Visualization on Paired Images: Degree of Contrast Enhancement
Time frame: 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)
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.
3 secondary outcomes
Pediatric Cohort: Lesion Visualization on Paired Images Compared With Pre Images: Border Delineation
Time frame: At MRI exam, Day 1 (pediatric cohort)
Pediatric Cohort: Lesion Visualization on Paired Images Compared With Pre Images: Internal Morphology
Time frame: At MRI exam, Day 1 (pediatric cohort)
Pediatric Cohort: Lesion Visualization on Paired Images Compared With Pre Images: Degree of Contrast Enhancement
Time frame: At MRI exam, day 1 (pediatric cohort)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toshiaki Taoka, MD principal investigator
Nagoya University, JAPAN
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gadopiclenol and Comparator (gadobutrol) in people with Lesion in Body Region and CNS Lesion, run by Guerbet at 27 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion Visualization on Paired Images: Border Delineation (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.