Optimizing Reduced-Flow, Low-Volume Contrast Protocols for Cerebral Angiography in Unruptured Ane… (NCT07302646) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Optimizing Reduced-Flow, Low-Volume Contrast Protocols for Cerebral Angiography in Unruptured Aneurysms
France244 participantsStarted 2026-03-01
Plain-language summary
Over the past two decades, interventional neuroradiology (INR) has seen significant advances in terms of safety and radiation protection. However, the management of iodinated contrast media (ICM) administered to the patients remains problematic. There is currently no reference for applying the ALADA (As Low As Diagnostically Acceptable) principle to ICM. In this context, optimising injection parameters seems essential to limit patient risks while maintaining sufficient diagnostic quality. To achieve this, it is necessary to work on a standardised procedure: the most frequently performed being diagnostic cerebral angiography for initial assessment or follow-up of intracranial aneurysms (IA). The aim of this project is to demonstrate that the use of injection protocols with reduced flow rates and volumes would enable non-inferior results compared to the empirical protocol (used in our department) in terms of image quality for the assessment of ICA, while improving examination comfort for patients.
A Randomised controlled non-inferiority study involving a four-arm factorial design to evaluate the impact of different ICM injection strategies in diagnostic cerebral angiography. Four groups will be compared: three experimental groups evaluating reductions in injection volumes and/or flow rates, and a control group following the standard protocol currently used in Strasbourg University Hospitals. Each subject will be randomly assigned to a group, and all images will be acquired using the same protocol. By following the standard care pathway and implementing safety procedures to ensure diagnostic quality, patients will not undergo any changes to their usual care and will not run any increased risk of diagnostic error.
Who can participate
Age range
18 Years – 80 Years
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:
Adult participant at the time of consent (age between 18 and 80 years old);
Scheduled diagnostic cerebral angiography as part of routine care:
* Initial assessment of the IA (suspected or detected in non-invasive imaging);
* Follow-up of one or more IAs (treated or untreated);
* Conscious and oriented participant, able to undergo the procedure under simple local anaesthesia;
* Participant able to understand the objectives of the research and provide a dated, signed informed consent form;
* Participant able to answer oral or written questions (French-speaking or understanding French);
* For women of childbearing potential: negative serum β-HCG test at the inclusion visit;
* Participant covered by a social security health insurance plan.
Exclusion Criteria:
* Emergency cerebral angiography;
* Participants with other neurovascular conditions (AVM, AVF, etc.) in addition to an IA;
* Participants with any contraindication to the use of ICM;
* Pregnancy or breastfeeding;
* Participants whose physical or psychological condition requires sedation or general anaesthesia for the procedure;
* Participants with communication or cognitive disorders; Incapable participants (subject to legal protection measures: curatorship, guardianship, judicial protection, future protection mandate, family authorization).
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.