Adnexal TorsionPhase 3AGATANCT04522219
Contribution of Contrast Enhanced Ultrasound in the Diagnosis of Adnexal Torsion
A Phase 3 study testing Contrast enhanced ultrasound in people with Adnexal Torsion, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Clinical diagnosis of adnexal torsion is difficult because the symptomatology is dominated by abrupt onset pelvic pain, an aspecific sign which does not allow a diagnosis of certainty to be made. To confirm the diagnosis, the reference examination is pelvic ultrasound with Doppler flow analysis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adnexal Torsion
- What is being tested?
- Contrast enhanced ultrasound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2021to 5 Jun 2023
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman over 18 years old
- Woman affiliated to a social security
- Woman having received complete information on the organization of the research and having given her informed consent in written form.
- Planned surgical intervention for suspected adnexal torsion
Who cannot join
- Patients under a measure of legal protection,
- Contraindication to contrast injection Hypersensitivity to sulfur hexafluoride or any of the other ingredients, history of cardiac disease, respiratory distress syndrome, severe pulmonary hypertension..
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contribution of Contrast Enhanced Ultrasound in the Diagnosis of Adnexal Torsion: a Prospective Comparative Study
Clinical diagnosis of adnexal torsion is difficult because the symptomatology is dominated by abrupt onset pelvic pain, an aspecific sign which does not allow a diagnosis of certainty to be made.
To confirm the diagnosis, the reference examination is pelvic ultrasound with Doppler flow analysis. However, its intake is low, its sensitivity varies from 46 to 73% depending on the studies. Other imaging techniques have been considered, such as MRI, with a sensitivity far superior to ultrasound, but its difficult accessibility, in particular in the context of an emergency, makes it unusable in clinical practice.
The use of ultrasound with the injection of an ultrasound contrast agent, strict intravascular, seems to be an interesting technique to assess the perfusion parameters of the ovary and improve the diagnostic sensitivity of the adnexal torsion. Its interest has already been demonstrated in the diagnosis of testicular torsion in animals but to date, no study has evaluated its contribution in adnexal torsion.
Read the detailed description
The primary objective is to evaluate the diagnostic performance of contrast enhanced ultrasound for the diagnosis of adnexal torsion in women with suspected adnexal torsion.
The secondary objectives are:
- To describe the perfusion parameters of the ovaries by contrast enhanced ultrasound
- To compare performance diagnosis of contrast ultrasound and bidimensional Doppler for the detection of adnexal torsion.
- To describe the perfusion parameters of the ovarian as a function of the degree of adnexal torsion.
- To compare perfusion parameters before and after ovarian detorsion
- To describe perfusion parameters of the ovarian by using MicroVascular Flow technique
- To assess the contribution of qualitative contrast ultrasound for the diagnosis of adnexal torsion (without clinical context)
- To assess inter-observer agreement on the qualitative analysis of ultrasound, without clinical context and then with clinical context.
- Conditions
- Adnexal Torsion
- Being tested
- Contrast enhanced ultrasound
- Keywords
- adnexal, torsion, ovarian, contrast enhanced ultrasound
- Medical subject headings
- Ovarian Torsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast enhanced ultrasoundDiagnostic test
Acquisition of contrast enhanced ultrasound. Contrast agent: SonoVue®: Hexafluoride (SonoVue®, injectable solution to solubilisate, 8µg/mL) is injected in all patients
| Study group | Role | What they receive |
|---|---|---|
| Case group | Experimental | Diagnosis of adnexal torsion confirmed by the surgical intervention: woman allocated to case group Receives: Diagnostic Test: Contrast enhanced ultrasound |
| Control group | Experimental | Diagnosis of adnexal torsion not confirmed by the surgical intervention: woman allocated to control group Receives: Diagnostic Test: Contrast enhanced ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal intensity measurement
to assess sensitivity, specificity, positive and negative predictive value of contrast enhanced ultrasound for detection of adnexal torsion in women with suspected adnexal torsion with realization of ROC curves
Measured: through study completion, on average of 36 months
Secondary outcomes (7)
vascularization of the ovaries on contrast enhanced ultrasound.
Measurement of perfusion parameters of the suspected ovarian torsion and the contralateral ovary if available:
Measured: through study completion, an average of 36 months
diagnostics performance
Measurement of signal intensities to assess sensibility and specificity of contrast enhanced ultrasound and bidimensional (2D) Doppler.
Measured: through study completion, an average of 36 months
vascularization of the ovaries according to the degree of torsion
Comparison of perfusion parameters of the ovary with the degree of torsion. The degree of torsion is defined by the number of twists (number of turns around the axis) detected during the surgical procedure.
Measured: through study completion, an average of 36 months
vascularization of the ovaries before and after detorsion
Measurement of signal intensities before and after ovarian detorsion
Measured: through study completion, an average of 36 months
Micro Vascular Flow technique
Measurement of signal intensities obtained by Micro Vascular Flow technique
Measured: through study completion, an average of 36 months
Qualitative evaluation of contrast enhancement
Presence or absence of contrast within the ovary. The presence of torsion is defined as for the primary objective.
Measured: through study completion, an average of 36 months
Reproducibility of qualitative evaluation of contrast enhancement
Diagnosis of adnexal torsion assessed by two observer on qualitative contrast ultrasound, without and with clinical context. Concordance will be assessed by the kappa coefficient
Measured: through study completion, an average of 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start13 Apr 2021
- Primary completion17 Aug 2022
- Study completion5 Jun 2023
Why it stopped: difficulties in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adnexal TorsionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Phase 3b, prospective, Case-Control study
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BERTHOLDT Charline, Central Hospital, Nancy, France
- Investigators
- Charline BERTHOLDT, Study chair, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522219
- Sponsor's protocol ID
- 2020-000993-27
- Acronym
- AGATA
- Status last verified
- Apr 2026
- First submitted
- 21 Jul 2020
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pillot R, Hossu G, Cherifi A, Guillez K, Morel O, Beaumont M, Fijean AL, Bertholdt C. Contribution of contrast-enhanced ultrasound in the diagnosis of adnexal torsion (AGATA): protocol for a prospective comparative study. BMJ Open. 2023 Aug 24;13(8):e073301. doi: 10.1136/bmjopen-2023-073301.
PubMed 37620263Fijean AL, Hossu G, Cherifi A, Beaumont M, Morel O, Bertholdt C. Improving diagnostic accuracy of ovarian torsion using contrast-enhanced ultrasound: A prospective comparative clinical study of performance diagnosis. Int J Gynaecol Obstet. 2026 Feb;172(2):1151-1158. doi: 10.1002/ijgo.70429. Epub 2025 Aug 5.
PubMed 40761032
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Contrast Enhanced Ultrasound in the Diagnosis of Adnexal Torsion: a Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT04522219
- Acronym / sponsor ID
- AGATA / 2020-000993-27
- Conditions
- Adnexal Torsion
- Keywords
- adnexal, torsion, ovarian, contrast enhanced ultrasound
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties in recruiting patients
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 5 Jun 2023 (actual)
- First posted
- 21 Aug 2020 (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.
Clinical diagnosis of adnexal torsion is difficult because the symptomatology is dominated by abrupt onset pelvic pain, an aspecific sign which does not allow a diagnosis of certainty to be made.
To confirm the diagnosis, the reference examination is pelvic ultrasound with Doppler flow analysis. However, its intake is low, its sensitivity varies from 46 to 73% depending on the studies. Other imaging techniques have been considered, such as MRI, with a sensitivity far superior to ultrasound, but its difficult accessibility, in particular in the context of an emergency, makes it unusable in clinical practice.
The use of ultrasound with the injection of an ultrasound contrast agent, strict intravascular, seems to be an interesting technique to assess the perfusion parameters of the ovary and improve the diagnostic sensitivity of the adnexal torsion. Its interest has already been demonstrated in the diagnosis of testicular torsion in animals but to date, no study has evaluated its contribution in adnexal torsion.
Detailed description
The primary objective is to evaluate the diagnostic performance of contrast enhanced ultrasound for the diagnosis of adnexal torsion in women with suspected adnexal torsion.
The secondary objectives are:
- To describe the perfusion parameters of the ovaries by contrast enhanced ultrasound
- To compare performance diagnosis of contrast ultrasound and bidimensional Doppler for the detection of adnexal torsion.
- To describe the perfusion parameters of the ovarian as a function of the degree of adnexal torsion.
- To compare perfusion parameters before and after ovarian detorsion
- To describe perfusion parameters of the ovarian by using MicroVascular Flow technique
- To assess the contribution of qualitative contrast ultrasound for the diagnosis of adnexal torsion (without clinical context)
- To assess inter-observer agreement on the qualitative analysis of ultrasound, without clinical context and then with clinical context.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 3b, prospective, Case-Control study
| Arm | Type | Receives |
|---|---|---|
| Case group | Experimental | Diagnostic Test: Contrast enhanced ultrasoundDiagnosis of adnexal torsion confirmed by the surgical intervention: woman allocated to case group |
| Control group | Experimental | Diagnostic Test: Contrast enhanced ultrasoundDiagnosis of adnexal torsion not confirmed by the surgical intervention: woman allocated to control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Woman over 18 years old
- Woman affiliated to a social security
- Woman having received complete information on the organization of the research and having given her informed consent in written form.
- Planned surgical intervention for suspected adnexal torsion
Key exclusion criteria (2 listed)
- Patients under a measure of legal protection,
- Contraindication to contrast injection Hypersensitivity to sulfur hexafluoride or any of the other ingredients, history of cardiac disease, respiratory distress syndrome, severe pulmonary hypertension..
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 |
|---|---|---|
| Contrast enhanced ultrasoundAcquisition of contrast enhanced ultrasound. Contrast agent: SonoVue®: Hexafluoride (SonoVue®, injectable solution to solubilisate, 8µg/mL) is injected in all patients | Diagnostic test | Case group, Control group |
Primary outcome
Signal intensity measurement
Time frame: through study completion, on average of 36 months
to assess sensitivity, specificity, positive and negative predictive value of contrast enhanced ultrasound for detection of adnexal torsion in women with suspected adnexal torsion with realization of ROC curves
7 secondary outcomes
vascularization of the ovaries on contrast enhanced ultrasound.
Time frame: through study completion, an average of 36 months
diagnostics performance
Time frame: through study completion, an average of 36 months
vascularization of the ovaries according to the degree of torsion
Time frame: through study completion, an average of 36 months
vascularization of the ovaries before and after detorsion
Time frame: through study completion, an average of 36 months
Micro Vascular Flow technique
Time frame: through study completion, an average of 36 months
Qualitative evaluation of contrast enhancement
Time frame: through study completion, an average of 36 months
Reproducibility of qualitative evaluation of contrast enhancement
Time frame: through study completion, an average of 36 months
Results and safety
The study was stopped early (reason given: difficulties in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 37620263Pillot R, Hossu G, Cherifi A, Guillez K, Morel O, Beaumont M, Fijean AL, Bertholdt C. Contribution of contrast-enhanced ultrasound in the diagnosis of adnexal torsion (AGATA): protocol for a prospective comparative study. BMJ Open. 2023 Aug 24;13(8):e073301. doi: 10.1136/bmjopen-2023-073301.
- Results publication: PubMed 40761032Fijean AL, Hossu G, Cherifi A, Beaumont M, Morel O, Bertholdt C. Improving diagnostic accuracy of ovarian torsion using contrast-enhanced ultrasound: A prospective comparative clinical study of performance diagnosis. Int J Gynaecol Obstet. 2026 Feb;172(2):1151-1158. doi: 10.1002/ijgo.70429. Epub 2025 Aug 5.
- Individual participant dataSharing planned: Undecided
Related trials for Adnexal Torsion
RecruitingPhase 3
Contribution of Contrast Enhanced Ultrasound for Diagnosis of Adnexal Torsion
Adnexal Torsion
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.
Charline BERTHOLDT study chair
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Contrast enhanced ultrasound in people with Adnexal Torsion, run by Central Hospital, Nancy, 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 4 inclusion and 2 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 8 Apr 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: difficulties in recruiting patients). 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?
Signal intensity measurement (time frame: through study completion, on average of 36 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 NCT04522219, which also lists 2 linked publications.
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 8 Apr 2026.