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

NCT ID: NCT07302646

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2028-03-02

Brief Summary

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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.

Detailed Description

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Conditions

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Interventional Neuroradiology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard (Reference)

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

Group Type ACTIVE_COMPARATOR

Standard (Reference)

Intervention Type 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 rate

Experimental group evaluating reduction in injection volume

Group Type EXPERIMENTAL

Reduced volume - standard flow rate

Intervention Type 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.

Standard volume - Reduced flow rate

Experimental group evaluating reduction in flow rate

Group Type EXPERIMENTAL

Standard volume - Reduced flow rate

Intervention Type 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 and flow rate

Experimental group evaluating reduction in injection volumes and flow rate

Group Type EXPERIMENTAL

Reduced volume and flow rate

Intervention Type 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.

Interventions

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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.

Intervention Type 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 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.

Intervention Type 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 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.

Intervention Type 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 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.

Intervention Type RADIATION

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Imagerie Interventionnelle Vasculaire Hôpitaux Universitaires de Strasbourg 1, place de l'Hôpital, 67 091 STRASBOURG Cedex

Strasbourg, , France

Site Status

Countries

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France

Central Contacts

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Nicolas DEHLINGER

Role: CONTACT

Phone: 06 43 33 15 44

Email: [email protected]

Facility Contacts

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Nicolas DEHLINGER

Role: primary

Other Identifiers

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2025-524884-18-00

Identifier Type: CTIS

Identifier Source: secondary_id

9882

Identifier Type: -

Identifier Source: org_study_id