Contribution of Contrast Enhanced Ultrasound in the Diagnosis of Adnexal Torsion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Contribution of Contrast Enhanced Ultrasound in the Diagnosis of Adnexal Torsion: a Prospective Comparative Study

Conditions
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Adnexal Torsion

Intervention / Treatment
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* Diagnostic Test: Contrast enhanced ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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..

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Phase 3b, prospective, Case-Control study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case group<br>Diagnosis of adnexal torsion confirmed by the surgical intervention: woman allocated to case group | Diagnostic Test: Contrast enhanced ultrasound<br>* Acquisition of contrast enhanced ultrasound. Contrast agent: SonoVue®: Hexafluoride (SonoVue®, injectable solution to solubilisate, 8µg/mL) is injected in all patients<br>|
| Experimental: Control group<br>Diagnosis of adnexal torsion not confirmed by the surgical intervention: woman allocated to control group | Diagnostic Test: Contrast enhanced ultrasound<br>* Acquisition of contrast enhanced ultrasound. Contrast agent: SonoVue®: Hexafluoride (SonoVue®, injectable solution to solubilisate, 8µg/mL) is injected in all patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | through study completion, on average of 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vascularization of the ovaries on contrast enhanced ultrasound. | Measurement of perfusion parameters of the suspected ovarian torsion and the contralateral ovary if available: | 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. | 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. | 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 | through study completion, an average of 36 months | 
| Micro Vascular Flow technique | Measurement of signal intensities obtained by Micro Vascular Flow technique | 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. | 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 | through study completion, an average of 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adnexal, torsion, ovarian, contrast enhanced ultrasound