New MRI dye shows promise in japanese patients
NCT ID NCT06010173
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase 3 trial tested gadopiclenol, a new MRI contrast agent, in 240 Japanese adults and children with known or suspected lesions in the brain or body. The study compared a lower dose of gadopiclenol to a standard dose of gadobutrol to see if it could provide equally clear images. The goal was to improve MRI safety by using less contrast material.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gadopiclenol (MRI contrast agent)
- What this could lead to
- If successful, this could confirm that a lower dose of gadopiclenol works as well as the standard contrast agent for MRI scans in Japanese patients.
- What could go wrong
- This is a completed Phase 3 trial, but results are not yet published. The study only included Japanese participants, so findings may not apply to other populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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240 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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May 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Inclusion criteria for all patients: 1. 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. 2. 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. 3. All Patient able and willing to participate in the trial. 4. All Patient affiliated to national health insurance according to local regulatory requirements. * Inclusion criteria for adult patients: 1. Female or male adult patient having reached legal majority age of 18 years. 2. 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. 3. 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. * Inclusion criteria for pediatric patients: 1. 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. 2. 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. 3. Patient with capacity of understanding who received age- and maturity-appropriate information and provided his/her assent to participate in the trial. 4. 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. Exclusion Criteria: * Non-inclusion criteria for all patients: 1. 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. 2. 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. 3. 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). 5. 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. 6. 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). 7. 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. 8. All Patient related to the Investigator or any other trial staff or relative directly involved in the trial conduct. 9. 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: 1. Patient with acute disease that might rapidly evolve between the 2 MRI examinations 2. Patient previously randomized in this trial. 3. 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). 4. 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: 1. Patient with previously attributed IMP number in this trial. 2. Patient with known long QT syndrome. 3. 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fukuoka University Hospital
Fukuoka, 814-0180, Japan
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Gifu University Hospital
Gifu, 501-1194, Japan
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Gunma University Hospital
Gunma, 371-8511, Japan
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Hamamatsu University Hospital
Shizuoka, 431-3192, Japan
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Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518, Japan
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Jichi Medical University Hospital
Tochigi, 329-0498, Japan
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Kanagawa Children's Medical Center
Kanagawa, 232-0066, Japan
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Kawasaki Medical School Hospital
Okayama, 701-0192, Japan
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Kobe City Medical Center General Hospital
Kobe, 650-0047, Japan
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Kurobe City Hospital
Toyama, 938-8502, Japan
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Kyoto City Hospital
Kyoto, 604-8845, Japan
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Meitetsu Hospital
Aichi, 451-8511, Japan
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Nakamura Memorial Hospital
Hokkaido, 060-8570, Japan
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Nara Medical University Hospital
Nara, 634-8522, Japan
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National Center for Child Health and Development
Tokyo, 157-8535, Japan
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National Hospital Organization Shikoku Medical Center for Children and Adults
Kagawa, 765-8507, Japan
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Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
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Saitama Prefectural Children's Medical Center
Saitama, 330-8777, Japan
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Shin-Kuki General Hospital
Saitama, 346-0021, Japan
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Shizuoka General Hospital
Shizuoka, 420-8527, Japan
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Toho University Omori Medical Center
Tokyo, 143-8541, Japan
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Tohoku University Hospital
Miyagi, 980-8574, Japan
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Tokyo Metropolitan Children's Medical Center
Tokyo, 183-8561, Japan
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Tokyo Shinagawa Hospital
Tokyo, 140-8522, Japan
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Tominaga Hospital
Osaka, 556-0017, Japan
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University Hospital, Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
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Yamaguchi University Hospital
Yamaguchi, 755-8505, Japan
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