Acute Abdominal PainIRMADANCT03281031
MRI as an Alternative to CT for Exploration of Acute Abdominal Pain in Young Women
A study testing Additional MRI Examination in people with Acute Abdominal Pain and Pelvic Pain, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Objective : To demonstrate diagnostic performances of Magnetic Resonance Imaging (MRI) as compared to Computed Tomography (CT) as a second intention imaging modality in young women with acute non traumatic abdominopelvic pain and non contributive ultrasonography. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Acute Abdominal Pain, Pelvic Pain
- What is being tested?
- Additional MRI Examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteFrance
- Study dates
- 18 Oct 2017to 19 Dec 2022
- Phase
- Interventional
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-40 years old
- Women referred to CT following a non contributive ultrasonography
- Women with acute non traumatic abdominopelvic pain (less than 5 day-duration)
- Women with informed consent
- Women with affiliation to health insurance
Who cannot join
- Women who underwent abdominopelvic surgery in the previous month
- Suspicion of vital emergency such as shock preventing any delayed management caused by MRI examination
- Contra-indication to MRI, including pace maker, ferro-magnetic material, foreign bodies with risk of mobilization during MRI examination
- Women yet included in the study or included in another study
- Women pregnant (positive beta chorionic gonadotrophic hormone testing) or breastfeeding
- Women unable to undergo informed consent (vulnerable or protected by law)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Performance of MRI as an Alternative to CT Following a Non-diagnostic Ultrasonography in Young Women With Acute/Subacute Abdominal Pain : a Prospective Multicenter Study
Objective :
To demonstrate diagnostic performances of Magnetic Resonance Imaging (MRI) as compared to Computed Tomography (CT) as a second intention imaging modality in young women with acute non traumatic abdominopelvic pain and non contributive ultrasonography.
Read the detailed description
Methods :
Consecutive women aged 18-40 years old with acute abdominopelvic pain referred to CT by the emergency Physician or gynaecologist after a non contributive ultrasonography will be included.
After obtaining informed consent, all patients will undergo standard CT followed by an additional MRI examination, performed using a short MRI protocol and within 6 hour from CT.
The gold standard or reference diagnosis will be established in consensus by an expert panel at 3 months follow up using a standardized diagnosis form.
A retrospective reading will be performed independently for CT and MRI by radiologists blinded to the reference diagnosis, using the same standardized diagnosis form.
CT and MRI accuracies will be compared.
- Conditions
- Acute Abdominal Pain, Pelvic Pain
- Being tested
- Additional MRI Examination
- Keywords
- MRI, Acute abdominal pain, Pelvic pain, Diagnostic performance, Young women
- Medical subject headings
- Abdomen, Acute, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional MRI ExaminationProcedure or surgery
MRI will be performed using a short protocol within 6 hours from CT and with blinding from CT results
| Study group | Role | What they receive |
|---|---|---|
| Additional MRI Examination | Other | Single arm, all patient will undergo CT followed by additional MRI examination Receives: Procedure: Additional MRI Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performances comparison between CT and MRI
Diagnostic performances (sensitivity, specificity, predictive values) comparison between CT and MRI
Measured: 3 months
Secondary outcomes (3)
Diagnostic performances of a conditional imaging strategy including first MRI for all cases and CT in cases where MRI is non contributive
Diagnostic performances (sensitivity, specificity and predictive values) of a conditional imaging strategy including first MRI for all cases and CT in cases where MRI is non contributive (strategy built retrospectively)
Measured: 3 months
Diagnostic performances of unenhanced MRI sequences versus complete MRI examination
Diagnostic performances (sensitivity, specificity and predictive values) of unenhanced MRI sequences versus complete MRI examination (including both unenhanced and enhanced sequences)
Measured: 3 months
Inter-reader agreement for MRI and CT diagnoses
Inter-reader agreement (Kappa statistics) for MRI and CT diagnoses (retrospective reading)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start18 Oct 2017
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
Why it stopped: Logistical constraints at the centers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Abdominal PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- Ingrid MILLET, MD, PhD, Principal investigator, Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281031
- Sponsor's protocol ID
- UF9803
- Other IDs
- 2017-A00725-48
- Acronym
- IRMADA
- Status last verified
- May 2026
- First submitted
- 27 Jul 2017
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Charret O, Fournier L, Poncelet E, Duraes M, Bobbia X, Bazot M, Beranger S, Chaumoitre K, Arcis E, Rousset P, Coutureau J, Fillias Q, Delebecq J, Pages-Bouic E, Molinari N, Nogue E, Taourel P, Millet I. MRI as an alternative to CT after inconclusive ultrasound in subacute/acute abdominal pain in young women: a prospective multicenter noninferiority study. Eur Radiol. 2025 Nov;35(11):6642-6654. doi: 10.1007/s00330-025-11629-7. Epub 2025 Apr 30.
PubMed 40307528
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of MRI as an Alternative to CT Following a Non-diagnostic Ultrasonography in Young Women With Acute/Subacute Abdominal Pain : a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT03281031
- Acronym / sponsor ID
- IRMADA / UF9803
- Conditions
- Acute Abdominal Pain, Pelvic Pain
- Keywords
- MRI, Acute abdominal pain, Pelvic pain, Diagnostic performance, Young women
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistical constraints at the centers
- Enrolment
- 149 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 13 Sep 2017 (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.
Objective :
To demonstrate diagnostic performances of Magnetic Resonance Imaging (MRI) as compared to Computed Tomography (CT) as a second intention imaging modality in young women with acute non traumatic abdominopelvic pain and non contributive ultrasonography.
Detailed description
Methods :
Consecutive women aged 18-40 years old with acute abdominopelvic pain referred to CT by the emergency Physician or gynaecologist after a non contributive ultrasonography will be included.
After obtaining informed consent, all patients will undergo standard CT followed by an additional MRI examination, performed using a short MRI protocol and within 6 hour from CT.
The gold standard or reference diagnosis will be established in consensus by an expert panel at 3 months follow up using a standardized diagnosis form.
A retrospective reading will be performed independently for CT and MRI by radiologists blinded to the reference diagnosis, using the same standardized diagnosis form.
CT and MRI accuracies will be compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Additional MRI Examination | Other | Procedure: Additional MRI ExaminationSingle arm, all patient will undergo CT followed by additional MRI examination |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 18-40 years old
- Women referred to CT following a non contributive ultrasonography
- Women with acute non traumatic abdominopelvic pain (less than 5 day-duration)
- Women with informed consent
- Women with affiliation to health insurance
Key exclusion criteria (6 listed)
- Women who underwent abdominopelvic surgery in the previous month
- Suspicion of vital emergency such as shock preventing any delayed management caused by MRI examination
- Contra-indication to MRI, including pace maker, ferro-magnetic material, foreign bodies with risk of mobilization during MRI examination
- Women yet included in the study or included in another study
- Women pregnant (positive beta chorionic gonadotrophic hormone testing) or breastfeeding
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 |
|---|---|---|
| Additional MRI ExaminationMRI will be performed using a short protocol within 6 hours from CT and with blinding from CT results | Procedure or surgery | Additional MRI Examination |
Primary outcome
Diagnostic performances comparison between CT and MRI
Time frame: 3 months
Diagnostic performances (sensitivity, specificity, predictive values) comparison between CT and MRI
3 secondary outcomes
Diagnostic performances of a conditional imaging strategy including first MRI for all cases and CT in cases where MRI is non contributive
Time frame: 3 months
Diagnostic performances of unenhanced MRI sequences versus complete MRI examination
Time frame: 3 months
Inter-reader agreement for MRI and CT diagnoses
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Logistical constraints at the centers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Results publication: PubMed 40307528Charret O, Fournier L, Poncelet E, Duraes M, Bobbia X, Bazot M, Beranger S, Chaumoitre K, Arcis E, Rousset P, Coutureau J, Fillias Q, Delebecq J, Pages-Bouic E, Molinari N, Nogue E, Taourel P, Millet I. MRI as an alternative to CT after inconclusive ultrasound in subacute/acute abdominal pain in young women: a prospective multicenter noninferiority study. Eur Radiol. 2025 Nov;35(11):6642-6654. doi: 10.1007/s00330-025-11629-7. Epub 2025 Apr 30.
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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.
Ingrid MILLET, MD, PhD principal investigator
Departement of Medical Imaging - Montpellier University Hospital LAPEYRONIE Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional MRI Examination in people with Acute Abdominal Pain and Pelvic Pain, 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 15 Jun 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?
The study was stopped early (reason given: Logistical constraints at the centers). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performances comparison between CT and MRI (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03281031, which also lists 1 linked publication.
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 15 Jun 2026.