Contribution of Contrast Enhanced Ultrasound in the Diagnosis of Adnexal Torsion (AGATA)

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.

Study Overview

• Status: Terminated
• Conditions: Adnexal Torsion
• Intervention / Treatment: Diagnostic test: Contrast enhanced ultrasound

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:

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Charline BERTHOLDT; Phone Number: +3383344312; Email: c.bertholdt@chru-nancy.fr

Study Locations

• France
  • Nancy, France, 54000
    • Centre Hospitalier Régional Universitaire de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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..

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Case group; Diagnosis of adnexal torsion confirmed by the surgical intervention: woman allocated to case group	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
Experimental: Control group; Diagnosis of adnexal torsion not confirmed by the surgical intervention: woman allocated to control group	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Study Chair: Charline BERTHOLDT, Centre Hospitalier Régional Universitaire de Nancy

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2021
• Primary Completion (Actual): August 17, 2022
• Study Completion (Actual): June 5, 2023

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: ovarian; contrast enhanced ultrasound; torsion; adnexal
• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Pathological Conditions, Anatomical; Torsion Abnormality; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Torsion
• Other Study ID Numbers: 2020-000993-27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No