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Optimizing Reduced-Flow, Low-Volume Contrast Protocols for Cerebral Angiography in Unruptured Aneurysms

Key facts

Who runs it
University Hospital, Strasbourg, France
Where
France1 site in 1 countryChoose a country to see its sites
Status
Not yet recruiting
People taking part
244 people, planned
Started
1 Mar 2026
Expected to end
2 Mar 2028
Type of study
Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Standard (Reference)
  • Reduced volume - standard flow rate
  • Standard volume - Reduced flow rate
  • Reduced volume and flow rate
Record updated
24 December 2025

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Participants with other neurovascular conditions (AVM, AVF, etc.) in addition to an IA
  • 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)
  • Emergency cerebral angiography
  • Participants with any contraindication to the use of ICM
  • Pregnancy or breastfeeding

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 4 groups in the trial

  • Standard (Reference)Existing treatment, for comparison

    A control group following the current standard protocol used in Strasbourg."

  • Reduced volume - standard flow rateTreatment being tested

    Experimental group evaluating reduction in injection volume

  • Standard volume - Reduced flow rateTreatment being tested

    Experimental group evaluating reduction in flow rate

  • Reduced volume and flow rateTreatment being tested

    Experimental group evaluating reduction in injection volumes and flow rate

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Fit questions
Built from NCT07302646, who can take part
Record updated
24 December 2025