RecruitingNot Applicable

Optimization of the Skin Test Procedure With Iodinated Contrast Products for Certain Patients Suspected of Immediate Hypersensitivity

France100 participantsStarted 2023-12-21

Plain-language summary

Hypersensitivity to iodinated contrast products (ICP) affects 1 to 3% of injected patients. These reactions require an allergological assessment with skin tests in order to distinguish allergic immunological mechanisms from other non-specific mechanisms. Current recommendations recommend carrying out prick tests followed by intradermal reactions up to a 10th dilution. However, undiluted IDRs are carried out by several teams under certain conditions, without this having been validated. Experience tends to show that these IDRs are relevant in certain patients to make the diagnosis without risk.

Who can participate

Age range

18 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: * Major subject (≥18 years old) * Subject treated in the allergology department in the period from June 1, 2020 to July 3, 2023 for suspected allergic hypersensitivity to ICPs and having had at least one undiluted intradermal reaction to one or more ICPs. * Absence of written opposition in the medical file of the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes. Exclusion Criteria: * Presence of opposition from the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.

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.

What they're measuring

Retrospective study of the relevance of performing pure intradermal reactions to iodinated contrast products (ICP) after obtaining a pure negative prick test.

Timeframe: Files analyzed retrospectively cover the period from June 1, 2020 to July 3, 2023.

Trial details

NCT IDNCT06498219

SponsorUniversity Hospital, Strasbourg, France

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12

Contact for this trial

Carine METZ-FAVRE, MD

33 3 69 55 06 84 carine.favre-metz@chru-strasbourg.fr

View on ClinicalTrials.gov More Contrast Sensitivity trials