Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children (NCT06010173) | Clinical Trial Compass
CompletedPhase 3
Evaluation of Gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese Adults and Children
Japan240 participantsStarted 2023-07-21
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lesion Visualization on Paired Images: Border Delineation
Timeframe: 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)
2
Lesion Visualization on Paired Images: Internal Morphology
Timeframe: 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)
3
Lesion Visualization on Paired Images: Degree of Contrast Enhancement
Timeframe: 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)
. 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.
Exclusion criteria
. 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.
. 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.