Efficacy and safety of gadopiclenol for Magnetic Resonance Imaging (MRI) in Japanese adults and children Phase III Clinical Trial

JRCT ID: jRCT2051230040

Registered date:16/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Contrast enhancing MRI in CNS or Body
• Date of first enrollment: 24/07/2023
• Target sample size: 240
• Study type: Interventional

Intervention(s)

Investigational Medicinal Product (IMP) 1, for adult patients and pediatric patients:
gadopiclenol, single intravenous bolus injection at 0.05 mmol/kg BW
Investigational Medicinal Product (IMP) 2, for adult patients only:
gadobutrol, single intravenous bolus injection at 0.1 mmol/kg BW
For both products the recommended rate is 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.

Outcome(s)

Primary Outcome

Primary Criterion - Adult Patients only (off-site read)
Lesion visualization: based on 3 co-primary criteria (border delineation, internal morphology and degree of contrast enhancement) assessed by 3 independent blinded off-site readers.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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 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.A Female or male adult patient having reached legal majority age of 18 years.
2.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.
3.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.
Inclusion criteria for pediatric patients:
1.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.
2.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.
3.P Patient with capacity of understanding who received age- and maturity-appropriate information and provided his/her assent to participate in the trial.
4.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.

Exclude criteria

Non-inclusion criteria for all patients:
1.All Patient referred for contrast-enhanced cardiac MRI as primary examination.
2.All Patient having received any investigational medicinal product 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 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).
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 GBCAs (such as hypersensitivity, post contrast acute kidney injury).
Non-inclusion criteria for adult patients:
1.A Patient with acute disease that may rapidly evolve between the 2 MRI examinations
2.A Patient previously randomized in this trial.
3.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).
4.A Patient presenting an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m^2 (based on Japanese coefficient-modified CKD-EPI formula) assessed within 1 week prior to each contrast agent administration.
Non-inclusion criteria for pediatric patients:
1.P Patient with previously attributed IMP number in this trial.
2.P Patient with known long QT syndrome.
3.P 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.

Related Information

• Primary Sponsor: Goto Takaaki