Interventional NeuroradiologyOPIACNCT07302646
Optimizing Reduced-Flow, Low-Volume Contrast Protocols for Cerebral Angiography in Unruptured Aneurysms
A study testing Standard (Reference), Reduced volume - standard flow rate and Standard volume - Reduced flow rate in people with Interventional Neuroradiology, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Interventional Neuroradiology
- What is being tested?
- Standard (Reference), Reduced volume - standard flow rate and Standard volume - Reduced flow rate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2026to 2 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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 join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Imagerie Interventionnelle Vasculaire Hôpitaux Universitaires de Strasbourg 1, place de l'Hôpital, 67 091 STRASBOURG Cedex
Strasbourg
Nicolas DEHLINGER, 06 43 33 15 44, nicolas.dehlinger@chru-strasbourg.fr
About this study
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
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.
- Conditions
- Interventional Neuroradiology
- Being tested
- Standard (Reference), Reduced volume - standard flow rate, Standard volume - Reduced flow rate, Reduced volume and flow rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard (Reference)Radiation
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 using the assigned injection protocol. Assessment of patient discomfort (EVS) and satisfaction (SAPS).
Data collection: ICM volume injected/consumed, radiation dose, and examination duration.
Image handling: Archiving and pseudonymisation of images for later analysis. End of participation: Patient participation ends after this visit.
Reduced volume - standard flow rateRadiation
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 using the assigned injection protocol. Assessment of patient discomfort (EVS) and satisfaction (SAPS).
Data collection: ICM volume injected/consumed, radiation dose, and examination duration.
Image handling: Archiving and pseudonymisation of images for later analysis. End of participation: Patient participation ends after this visit.
Standard volume - Reduced flow rateRadiation
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 using the assigned injection protocol. Assessment of patient discomfort (EVS) and satisfaction (SAPS).
Data collection: ICM volume injected/consumed, radiation dose, and examination duration.
Image handling: Archiving and pseudonymisation of images for later analysis. End of participation: Patient participation ends after this visit.
Reduced volume and flow rateRadiation
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 using the assigned injection protocol. Assessment of patient discomfort (EVS) and satisfaction (SAPS).
Data collection: ICM volume injected/consumed, radiation dose, and examination duration.
Image handling: Archiving and pseudonymisation of images for later analysis. End of participation: Patient participation ends after this visit.
| Study group | Role | What they receive |
|---|---|---|
| Standard (Reference) | Active comparator | A control group following the current standard protocol used in Strasbourg." Receives: Radiation: Standard (Reference) |
| Reduced volume - standard flow rate | Experimental | Experimental group evaluating reduction in injection volume Receives: Radiation: Reduced volume - standard flow rate |
| Standard volume - Reduced flow rate | Experimental | Experimental group evaluating reduction in flow rate Receives: Radiation: Standard volume - Reduced flow rate |
| Reduced volume and flow rate | Experimental | Experimental group evaluating reduction in injection volumes and flow rate Receives: Radiation: Reduced volume and flow rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of exploitable 2D and 3D images
Ratio of exploitable 2D and 3D images, assessed by radiographers, obtained with each injection protocol (reduced flow rates/standard volumes; reduced volumes/standard flow rates; reduced flow rates and volumes), compared to the standard/empirical protocol
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion2 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interventional NeuroradiologyStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302646
- Sponsor's protocol ID
- 9882
- Other IDs
- 2025-524884-18-00, 2025
- Acronym
- OPIAC
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07302646
- Acronym / sponsor ID
- OPIAC / 9882
- Conditions
- Interventional Neuroradiology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 2 Mar 2028 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard (Reference) | Active comparator | Radiation: Standard (Reference)A control group following the current standard protocol used in Strasbourg." |
| Reduced volume - standard flow rate | Experimental | Radiation: Reduced volume - standard flow rateExperimental group evaluating reduction in injection volume |
| Standard volume - Reduced flow rate | Experimental | Radiation: Standard volume - Reduced flow rateExperimental group evaluating reduction in flow rate |
| Reduced volume and flow rate | Experimental | Radiation: Reduced volume and flow rateExperimental group evaluating reduction in injection volumes and flow rate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult participant at the time of consent (age between 18 and 80 years old);
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 using the assigned injection protocol. Assessment of patient discomfort (EVS) and satisfaction (SAPS). Data collection: ICM volume injected/consumed, radiation dose, and examination duration. Image handling: Archiving and pseudonymisation of images for later analysis. End of participation: Patient participation ends after this visit. | Radiation | Standard (Reference) |
| Reduced volume - standard flow rateSelection 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 using the assigned injection protocol. Assessment of patient discomfort (EVS) and satisfaction (SAPS). Data collection: ICM volume injected/consumed, radiation dose, and examination duration. Image handling: Archiving and pseudonymisation of images for later analysis. End of participation: Patient participation ends after this visit. | Radiation | Reduced volume - standard flow rate |
| Standard volume - Reduced flow rateSelection 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 using the assigned injection protocol. Assessment of patient discomfort (EVS) and satisfaction (SAPS). Data collection: ICM volume injected/consumed, radiation dose, and examination duration. Image handling: Archiving and pseudonymisation of images for later analysis. End of participation: Patient participation ends after this visit. | Radiation | Standard volume - Reduced flow rate |
| Reduced volume and flow rateSelection 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 using the assigned injection protocol. Assessment of patient discomfort (EVS) and satisfaction (SAPS). Data collection: ICM volume injected/consumed, radiation dose, and examination duration. Image handling: Archiving and pseudonymisation of images for later analysis. End of participation: Patient participation ends after this visit. | Radiation | Reduced volume and flow rate |
Primary outcome
Ratio of exploitable 2D and 3D images
Time frame: 1 day
Ratio of exploitable 2D and 3D images, assessed by radiographers, obtained with each injection protocol (reduced flow rates/standard volumes; reduced volumes/standard flow rates; reduced flow rates and volumes), compared to the standard/empirical protocol
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard (Reference), Reduced volume - standard flow rate and Standard volume - Reduced flow rate in people with Interventional Neuroradiology, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas DEHLINGER (06 43 33 15 44, nicolas.dehlinger@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of exploitable 2D and 3D images (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.