Contrast Media AllergyPersensPCNCT07409051
Persistence of Sensitization to Contrast Media
An observational study of Contrast Media Allergy, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Media Allergy
- What is being tested?
- Skin testing and Baseline serum tryptase measurement
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2026to Feb 2028
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Drug Allergy and Hypersensitivity Database of the Allergy Exploration Unit, Montpellier University Hospital (CHU Montpellier).
Who may be able to join
- Adult patients (≥18 years) with confirmed IgE-mediated allergy to contrast media products after a first exposure.
Who cannot join
- 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.
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
CHU Montpellier
Montpellier
CHIRIAC, Dr, +33 4 67 33 6107, a-chiriac@chu-montpellier.fr
About this study
Official title: Evolution of IgE-mediated Sensitization to Contrast Media in Allergic Patients Diagnosed by Positive Skin Tests
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.
Read the detailed description
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.
- Conditions
- Contrast Media Allergy
- Being tested
- Skin testing, Baseline serum tryptase measurement
- Keywords
- IgE, Allergy, Contrast Media, Skin test
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin testingDiagnostic 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.
Baseline serum tryptase measurementOther
Seven milliliters of venous blood will be collected for baseline serum tryptase measurement.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Skin testing; Other: Baseline serum tryptase measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Inclusion
Secondary outcomes (1)
Risk factors of patients with IgE-mediated hypersensitivity to contrast media
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.
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast Media AllergyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr CHIRIAC, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409051
- Sponsor's protocol ID
- RECHMPL22_0320
- Acronym
- PersensPC
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2026
- Last updated
- 13 Feb 2026
- 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of IgE-mediated Sensitization to Contrast Media in Allergic Patients Diagnosed by Positive Skin Tests
- ClinicalTrials.gov ID
- NCT07409051
- Acronym / sponsor ID
- PersensPC / RECHMPL22_0320
- Conditions
- Contrast Media Allergy
- Keywords
- IgE, Allergy, Contrast Media, Skin test
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 13 Feb 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IgE-dependent allergy to contrast media | – | Diagnostic Test: Skin testing, Other: Baseline serum tryptase measurementSkin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Drug Allergy and Hypersensitivity Database of the Allergy Exploration Unit, Montpellier University Hospital (CHU Montpellier).
Key inclusion criteria (1 listed)
- Adult patients (≥18 years) with confirmed IgE-mediated allergy to contrast media products after a first exposure.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Skin testingCommercial 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. | Diagnostic test | IgE-dependent allergy to contrast media |
| Baseline serum tryptase measurementSeven milliliters of venous blood will be collected for baseline serum tryptase measurement. | Other | IgE-dependent allergy to contrast media |
Primary outcome
Prevalence of IgE-mediated allergy to contrast media after the first exposure
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
1 secondary outcome
Risk factors of patients with IgE-mediated hypersensitivity to contrast media
Time frame: Inclusion
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 13 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Contrast Media Allergy
Not yet recruiting
1-hour Premedication for Allergy Goal in Emergency: PAGE-1 Study
Allergic Reaction to Contrast Media, Hypersensitivity Reaction
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.
Dr CHIRIAC principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contrast Media Allergy, run by University Hospital, Montpellier 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 1 inclusion and 7 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 13 Feb 2026. 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 Dr CHIRIAC (+33 04 67 33 61 07, a-chiriac@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of IgE-mediated allergy to contrast media after the first exposure (time frame: Inclusion). 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 13 Feb 2026.