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A study to learn how gadoquatrane moves into, through, and out of the body and how safe it is in children aged 0 to less than 18 years, who will undergo a contrast enhanced MRI
EU CTIS ID: 2022-501883-17-00
What this study is testing
To evaluate plasma PK of gadoquatrane after a single intravenous injection of 0.04 mmol Gd/kg bw in pediatric participants undergoing CE-MRI
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants from birth to <18 years of age at the time of signing the informed consent form
- Participants who have a clinical indication to undergo a CE-MRI for any clinical condition in any body region and who can undergo study procedures as per Investigator judgement
- Participants can be male or female (according to their reproductive organs and functions assigned by chromosomal complement)
- Female contraception and barriers as well as pregnancy testing is required as appropriate for the age and sexual activity of pediatric participants and as required by local regulations
- The legal guardian(s) is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- When applicable by law for a participant, a legal guardian must be available to help the study-site personnel ensure follow up, accompany the participant to the study site on each assessment day, and consistently and consecutively be available to provide information on the participant during the scheduled study visits
You likely can't join if
- Body weight <2500 g at screening and baseline
- Participants who received or will receive any other contrast agent within 72 hours prior to gadoquatrane injection or up to 72 hours after gadoquatrane injection
- Contraindications to the administration of GBCAs (depending on local product label), or history of adverse reaction to GBCAs
- The medical condition and/or local allowance for maximum blood draw in the pediatric participant is not suitable for study procedures, including PK and safety blood draws, without compromising any expected clinical care/procedure need
- Acute kidney injury (i.e., acute renal failure)
- Age-adjusted renal function is "decreased" (eGFR <80% of age adjusted normal renal function) as evaluated by the investigator based on a serum or plasma creatinine result obtained within 2 weeks prior to study intervention.
See the full eligibility criteria
Who can join
- Participants from birth to <18 years of age at the time of signing the informed consent form
- Participants who have a clinical indication to undergo a CE-MRI for any clinical condition in any body region and who can undergo study procedures as per Investigator judgement
- Participants can be male or female (according to their reproductive organs and functions assigned by chromosomal complement)
- Female contraception and barriers as well as pregnancy testing is required as appropriate for the age and sexual activity of pediatric participants and as required by local regulations
- The legal guardian(s) is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- When applicable by law for a participant, a legal guardian must be available to help the study-site personnel ensure follow up, accompany the participant to the study site on each assessment day, and consistently and consecutively be available to provide information on the participant during the scheduled study visits
What rules you out
- Body weight <2500 g at screening and baseline
- Participants who received or will receive any other contrast agent within 72 hours prior to gadoquatrane injection or up to 72 hours after gadoquatrane injection
- Contraindications to the administration of GBCAs (depending on local product label), or history of adverse reaction to GBCAs
- The medical condition and/or local allowance for maximum blood draw in the pediatric participant is not suitable for study procedures, including PK and safety blood draws, without compromising any expected clinical care/procedure need
- Acute kidney injury (i.e., acute renal failure)
- Age-adjusted renal function is "decreased" (eGFR <80% of age adjusted normal renal function) as evaluated by the investigator based on a serum or plasma creatinine result obtained within 2 weeks prior to study intervention.
- Considered clinically unstable or has a concurrent/concomitant condition that may not allow participation for the full planned study period, in the judgement of the investigator
- History of moderate to severe allergic-like reaction to any GBCA
- Bronchial asthma which is considered unstable or had major therapeutical modification within last 4 weeks.
- Severe cardiovascular disease, except for cardiac or vascular magnetic resonance (MR), if considered clinically justified by the investigator
- Planned or expected intervention (e.g., treatment or procedure) or change in treatment (e.g. start of chemotherapy) that may significantly affect study parameters (i.e. safety/AEs [e.g. confounding AEs or safety events due to surgery or chemotherapy], PK parameters) or would prevent the participant from performing study procedures, from the administration of gadoquatrane up to the 24 h ± 4 h follow-up
The study team makes the final eligibility decision.
Where it's taking place
- China
- Argentina
- United States
- Canada
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Argentina; United States; Canada; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.