Contrast SensitivityOPT-TC-PCINCT06498219
Optimization of the Skin Test Procedure With Iodinated Contrast Products for Certain Patients Suspected of Immediate Hypersensitivity
An observational study of Contrast Sensitivity, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Sensitivity
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Major subject (≥18 years old) 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.
Who may be able to join
- 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.
Who cannot join
- Presence of opposition from the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Pneumologie - CHU de Strasbourg - France
Strasbourg, 67091
Carine METZ-FAVRE, MD, 33 3 69 55 06 84, carine.favre-metz@chru-strasbourg.fr
Carine METZ-FAVRE, MD
About this study
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.
- Conditions
- Contrast Sensitivity
- Keywords
- Contrast Sensitivity, Iodinated contrast products, Allergic immunological mechanisms, Allergy
- Medical subject headings
- Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of the relevance of performing pure intradermal reactions to iodinated contrast products (ICP) after obtaining a pure negative prick test.
This retrospective study concerns patients treated at the Strasbourg University Hospital in the period from June 1, 2020 to July 3, 2023 for suspected allergic hypersensitivity to (ICP) and having had at least one undiluted intradermal reaction to one or more (ICP) .
Measured: Files analyzed retrospectively cover the period from June 1, 2020 to July 3, 2023.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start21 Dec 2023
- Primary completionDec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast SensitivityStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498219
- Sponsor's protocol ID
- 9025
- Acronym
- OPT-TC-PCI
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Skin Test Procedure With Iodinated Contrast Products for Certain Patients Suspected of Immediate Hypersensitivity
- ClinicalTrials.gov ID
- NCT06498219
- Acronym / sponsor ID
- OPT-TC-PCI / 9025
- Conditions
- Contrast Sensitivity
- Keywords
- Contrast Sensitivity, Iodinated contrast products, Allergic immunological mechanisms, Allergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Jul 2024 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥18 years old) 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Presence of opposition from the subject (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective study of the relevance of performing pure intradermal reactions to iodinated contrast products (ICP) after obtaining a pure negative prick test.
Time frame: Files analyzed retrospectively cover the period from June 1, 2020 to July 3, 2023.
This retrospective study concerns patients treated at the Strasbourg University Hospital in the period from June 1, 2020 to July 3, 2023 for suspected allergic hypersensitivity to (ICP) and having had at least one undiluted intradermal reaction to one or more (ICP) .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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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. This study is not recruiting at the moment.
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 Sensitivity, run by University Hospital, Strasbourg, France 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carine METZ-FAVRE, MD (33 3 69 55 06 84, carine.favre-metz@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study of the relevance of performing pure intradermal reactions to iodinated contrast products (ICP) after obtaining a pure negative prick test. (time frame: Files analyzed retrospectively cover the period from June 1, 2020 to July 3, 2023.). 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 12 Jul 2024.