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

April 2, 2026 updated by: BERTHOLDT Charline, Central Hospital, Nancy, France

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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
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.
Time Frame: through study completion, an average of 36 months
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
Time Frame: through study completion, an average of 36 months
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
Time Frame: through study completion, an average of 36 months
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
Time Frame: through study completion, an average of 36 months
Measurement of signal intensities before and after ovarian detorsion
through study completion, an average of 36 months
Micro Vascular Flow technique
Time Frame: through study completion, an average of 36 months
Measurement of signal intensities obtained by Micro Vascular Flow technique
through study completion, an average of 36 months
Qualitative evaluation of contrast enhancement
Time Frame: through study completion, an average of 36 months
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
Time Frame: through study completion, an average of 36 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Study Chair: Charline BERTHOLDT, Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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