CHU Montpellier
Montpellier, France
NCT Number: NCT07409051
The study aims to evaluate the persistence of IgE-mediated allergy to contrast media (CM) after a second exposure in patients who tested positive at both the first and second evaluations for CM allergy. It also aims to analyze the risk factors associated with the persistence of IgE-mediated sensitization after the second allergological assessment.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Montpellier, France
Drug allergy is often overdiagnosed, as only about 25% of cases labeled as allergic are confirmed. IgE-mediated drug allergy, responsible for immediate reactions up to anaphylaxis, carries inherent risks and relies primarily on in vivo testing, supplemented by in vitro assays in selected cases. In vivo assessment includes skin tests (ST), which, when positive, detect drug-specific IgE bound to mast cells, and drug provocation tests (DPT), which involve controlled re-exposure to the suspected drug.
When IgE-mediated allergy is confirmed, drugs with positive ST are strictly contraindicated for life. Drugs with negative ST are generally considered safe, and tolerance is often verified through DPT performed in specialized settings using stepwise dose escalation up to near-therapeutic doses. In some cases, drugs are reintroduced directly in real-life conditions without prior DPT.
Contrast media (CM) can trigger systemic reactions even at very low doses. In such cases, in vitro testing should ideally precede DPT to minimize systemic exposure. However, its use is limited by the small number of commercially available drug allergens, the need for specialized expertise for techniques such as the basophil activation test, and variable sensitivity depending on the drug, which remains largely unknown for CM. Skin testing for CM allergy has a very high negative predictive value (>95%), indicating that most patients with negative ST tolerate subsequent CM exposure. As a result, many centers do not systematically perform DPT after negative ST.
Evidence suggests that IgE-mediated drug allergy, including CM allergy, may decline over time, with conversion from positive to negative ST occurring after several years. However, it is unclear whether this reflects a true loss of clinical allergy, as documented re-exposures are rare and mostly anecdotal. Clinical experience shows that allergy may either resolve or persist despite negative follow-up tests.
Finally, the severity of drug-induced allergic reactions may be increased in patients with mast cell activation syndrome or mastocytosis, conditions characterized by elevated mast cell burden or reactivity and often suspected in the presence of elevated baseline serum tryptase levels.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Commercial contrast media will be used to perform skin prick testing or intradermal testing with 0.02-0.05 mL of allergenic solution. If not previously performed, a standard panel of prick tests with environmental allergens will be used to assess atopic status. Positive (histamine 10 mg/mL) and negative (saline) controls will be included.
Skin testing will begin with prick tests, starting at the dilution that was positive during the initial evaluation. If negative, testing will proceed with intradermal injections using increasing concentrations until a positive response is observed. Once a positive result is obtained, skin testing for that contrast medium will be discontinued.
A prick test will be considered positive if a wheal ≥3 mm with erythema and pruritus appears after 15 minutes. An intradermal test will be considered positive if a wheal ≥3 mm with erythema and pruritus appears after 20 minutes.
Seven milliliters of venous blood will be collected for baseline serum tryptase measurement.
Time frame: Inclusion
A skin prick test is considered positive if, after 15 minutes, a wheal measuring at least 3 mm appears, associated with erythema and pruritus. An intradermal test is considered positive if, after 20 minutes, a wheal measuring at least 3 mm appears, associated with erythema and pruritus
Time frame: Inclusion
The presence of risk factors will be determined by analyzing the association between data extracted from the Drug Allergy and Hypersensitivity Database (DAHD) (i.e., sociodemographic characteristics, initial reaction to contrast media, results of the first allergy tests, and the presence of other allergic factors) and the persistence of reactivity to contrast media in patients with serum tryptase levels higher than 11 µg/L.
Contact information is provided by the study sponsor or research team.
University Hospital, Montpellier
Other
Evolution of IgE-mediated Sensitization to Contrast Media in Allergic Patients Diagnosed by Positive Skin Tests
Acronym: PersensPC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07611435
Allergy, Alpha-Gal Syndrome
Little Rock, Arkansas, United States
View Trial DetailsNCT07631039
Allergy, Disease
Béziers, Occitanie, France
View Trial DetailsNCT07613905
Hypersensitivity, Hypersensitivity Reaction
Fuzhou, Fujian, China
View Trial DetailsNCT07573202
Allergic Contact Dermatitis, Dermatitis
Houston, Texas, United States
View Trial Details