Contribution of Contrast Enhanced Ultrasound in the Diagnosis of Adnexal Torsion

Adnexal Torsion Clinical Trial

— AGATA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04522219
• Other study ID #: 2020-000993-27
• Status: Terminated
• Phase: Phase 3
• Start date: April 13, 2021
• Est. completion date: June 5, 2023

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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: 1. To describe the perfusion parameters of the ovaries by contrast enhanced ultrasound 2. To compare performance diagnosis of contrast ultrasound and bidimensional Doppler for the detection of adnexal torsion. 3. To describe the perfusion parameters of the ovarian as a function of the degree of adnexal torsion. 4. To compare perfusion parameters before and after ovarian detorsion 5. To describe perfusion parameters of the ovarian by using MicroVascular Flow technique 6. To assess the contribution of qualitative contrast ultrasound for the diagnosis of adnexal torsion (without clinical context) 7. To assess inter-observer agreement on the qualitative analysis of ultrasound, without clinical context and then with clinical context.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: June 5, 2023
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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..

Related Conditions & MeSH terms

• Adnexal Torsion
• Ovarian Torsion

Intervention

Diagnostic Test:
• Contrast enhanced ultrasound
Acquisition of contrast enhanced ultrasound. Contrast agent: SonoVue®: Hexafluoride (SonoVue®, injectable solution to solubilisate, 8µg/mL) is injected in all patients

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Micro Vascular Flow technique	Measurement of signal intensities obtained by Micro Vascular Flow technique	through study completion, an average of 36 months
Secondary	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
Secondary	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