Optimizing Reduced-Flow, Low-Volume Contrast Protocols for Cerebral Angiography in Unruptured Aneurysms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard (Reference), Reduced volume - standard flow rate, Standard volume - Reduced flow rate, Reduced volume and flow rate.
- Who it may be relevant to
- Registry conditions: Interventional Neuroradiology. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Iodinated Contrast Media Injection Protocols With Reduced Flow Rates and Volumes on Image Quality in Diagnostic Cerebral Angiography for the Evaluation of Unruptured Intracranial Aneurysms: Towards a Standardization of Practices
Overview
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.
Interventions
- Radiation Standard (Reference)
Selection visit (D-40 to D-7): Patient information on cerebral angiography (standard consultation) and study objectives. Delivery of the information document and reflection period. Verification of eligibility criteria. Inclusion visit (D0): Review of study objectives and Q\&A. Final verification of eligibility criteria. Obtaining of free and informed consent. Randomisation and assignment to an injection protocol. Angiography performed according to standard practice, with image acquisition usin - Radiation Reduced volume - standard flow rate
Selection visit (D-40 to D-7): Patient information on cerebral angiography (standard consultation) and study objectives. Delivery of the information document and reflection period. Verification of eligibility criteria. Inclusion visit (D0): Review of study objectives and Q\&A. Final verification of eligibility criteria. Obtaining of free and informed consent. Randomisation and assignment to an injection protocol. Angiography performed according to standard practice, with image acquisition usin - Radiation Standard volume - Reduced flow rate
Selection visit (D-40 to D-7): Patient information on cerebral angiography (standard consultation) and study objectives. Delivery of the information document and reflection period. Verification of eligibility criteria. Inclusion visit (D0): Review of study objectives and Q\&A. Final verification of eligibility criteria. Obtaining of free and informed consent. Randomisation and assignment to an injection protocol. Angiography performed according to standard practice, with image acquisition usin - Radiation Reduced volume and flow rate
Selection visit (D-40 to D-7): Patient information on cerebral angiography (standard consultation) and study objectives. Delivery of the information document and reflection period. Verification of eligibility criteria. Inclusion visit (D0): Review of study objectives and Q\&A. Final verification of eligibility criteria. Obtaining of free and informed consent. Randomisation and assignment to an injection protocol. Angiography performed according to standard practice, with image acquisition usin
Primary outcome measures
- Ratio of exploitable 2D and 3D images [Time frame: 1 day]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
France · 1 center
- Imagerie Interventionnelle Vasculaire Hôpitaux Universitaires de Strasbourg 1, place de l' — Strasbourg
Identifiers
NCT: NCT07302646 · 9882 · 2025-524884-18-00