Persistence of Sensitization to Contrast Media

NCT07409051 | Not Yet Recruiting

• 1 other identifier: RECHMPL22_0320
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Contrast Media Allergy

Keywords

IgE; Allergy; Contrast Media; Skin test

Outcome Measures

Primary Outcomes (1)

• Prevalence of IgE-mediated allergy to contrast media after the first exposure

  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

  Inclusion

Secondary Outcomes (1)

• Risk factors of patients with IgE-mediated hypersensitivity to contrast media

  Inclusion

Study Arms (1)

IgE-dependent allergy to contrast media

Skin testing using the prick method, involving gentle skin pricking at the site of allergen application, or intradermal testing (IDT) with 0.02-0.05 mL of allergenic solution will be performed in patients with a clinical history of hypersensitivity to contrast media. Baseline serum tryptase measured in blood samples will also be used as an indicator of hypersensitivity to contrast media, with values higher than 11 µg/L considered elevated.

Diagnostic Test: Skin testing; Other: Baseline serum tryptase measurement

Interventions

Skin testing DIAGNOSTIC_TEST

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.

IgE-dependent allergy to contrast media

Baseline serum tryptase measurement OTHER

Seven milliliters of venous blood will be collected for baseline serum tryptase measurement.

IgE-dependent allergy to contrast media

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Drug Allergy and Hypersensitivity Database of the Allergy Exploration Unit, Montpellier University Hospital (CHU Montpellier).

You may qualify if:

• \- Adult patients (≥18 years) with confirmed IgE-mediated allergy to contrast media products after a first exposure.

You may not qualify if:

• Patients receiving H1 antihistamines for an allergic condition at the time of evaluation.
• Patients with active eczema and/or uncontrolled asthma.
• Pregnant or breastfeeding women, or women who have recently given birth.
• Individuals under legal protection (e.g., guardianship).
• Individuals deprived of liberty or involved in judicial proceedings.
• Individuals without health insurance coverage.
• Absence of clear, written informed consent.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and serum samples

MeSH Terms

Conditions

Hypersensitivity

Interventions

Skin Tests

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Dr CHIRIAC

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr CHIRIAC

CONTACT

+33 04 67 33 61 07; a-chiriac@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 13, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-01

Locations

FR (1)