Recruiting

NCT Number: NCT06677554

Contribution of Contrast Enhanced Ultrasound for Diagnosis of Adnexal Torsion

Adnexal torsion is the rotation of the ovary around its vascular axis resulting, in the absence of treatment, ischemia that can lead to peritonitis by necrosis or impaired fertility. It is a gynecological emergency affecting 3% of women of childbearing age, including from adolescence, and requires surgical treatment as soon as possible, classically within 6 hours.

The symptomatology of adnexal torsion is dominated by pelvic pain of sudden onset and variable intensity, an aspecific sign that does not allow a diagnosis of certainty. There are no biological markers and, in the context of the emergency, the only imaging examination available is pelvic ultrasound associated with a Doppler flow analysis but with a low and variable diagnostic performance depending on the studies (sensitivity variable from 46 to 73%).

There are currently no tests that can provide a diagnosis of certainty. Only surgical exploration, carried out at the discretion of the practitioner on the basis of a bundle of arguments, can confirm or refute the diagnosis. However, this management strategy leads to the realization of emergency surgical interventions wrongly since 3 out of 10 women will finally not have an adnexal torsion (PMSI data from participating centers: 30 to 45% false positives).

Contrast ultrasound is a technique that uses a strict intravascular product to assess the vascularization of the ovary and offers a high diagnostic performance in the context of adnexal torsion. Indeed, a retrospective study, published in 2021, reports a sensitivity of 94% and a specificity of 100%. The preliminary results of our pilot study (AGATA APJC 2019, Dr Bertholdt, NCT04522219) also go in this direction with a sensitivity of 100%, a specificity of 86% and a negative predictive value of 100% (data being published).

The COVARIAN project, second stage of the AGATA project, aims to demonstrate that the addition of a contrast evaluation to standard ultrasound in the diagnostic strategy in case of suspicion of adnexal torsion improves the health of women by reducing the rate of wrongly surgery, that is, without proven torsion.

COVARIAN will be the first prospective multicenter randomized study evaluating the direct benefit for women of using ultrasound contrast evaluation in the management strategy in case of suspicion of adnexal torsion.

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Key information

Conditions

Adnexal Torsion Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Ovarian Torsion Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Torsion Abnormality Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

CHU, Besançon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18 or over
Person who has carried out a preliminary clinical examination adapted to the clinical trial
Strong suspicion of adnexal torsion with surgery planned
No ongoing pregnancy or breastfeeding
Affiliation to or beneficiary of a social security scheme
Person who has received complete information on the organization of the research and has signed their informed consent

Exclusion criteria

Person who does not understand and/or speak French
Any medical situation that does not indicate the administration of SonoVue®, including:

Known hypersensitivity to sulphur hexafluoride or any of the other components of SonoVue
Woman with acute coronary syndrome or unstable ischemic heart disease
Woman with acute endocarditis
Woman with valve prostheses
Women with acute systemic inflammatory disease and/or sepsis
Woman with hypercoagulation and/or recent thromboembolic accident
End-stage woman with kidney or liver disease
Woman with right-left shunt, severe pulmonary hypertension (pulmonary arterial pressure > 90 mmHg)
Women with uncontrolled systemic hypertension
Woman with respiratory distress syndrome
Medical condition contraindicating the administration of SonoVue®,
History of PEG allergy (or macrogol)
Person referred to in Articles 10, 31, 32, 33 and 34 of Regulation EU 536/2014:

Pregnant, parturient or breastfeeding/nursing mother
Minor (not emancipated)
Adult subject to a legal protection measure (guardianship, curatorship, safeguarding of justice)
Person of legal age who is unable to express consent

Treatment and study plan

Addition of ultrasound with contrast injection (SonoVue®)

Drug

Addition of contrast evaluation with SonoVue® injection (5 min including 1 min of acquisition) within the diagnostic strategy

Standard Care (in control arm)

Other

No addition of ultrasound with contrast

Primary outcomes

Evaluation of the two-stage diagnostic strategy effectiveness

Time frame: 38 months

Percentage of surgical procedures performed in emergency (within 6 hours of arrival of the patient) without proven torsion (no visible spiral turn in intraoperative) in each group.

Study contacts

Contact information is provided by the study sponsor or research team.

Charline BERTHOLDT, Pr

CONTACT

[email protected]

+33 383 344 312

Dorine MANHERTZ, MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

COVARIAN - Contribution of Contrast Enhanced Ultrasound for Diagnosis of Adnexal Torsion: a Randomized Controlled Trial

Acronym: COVARIAN

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Nov 6, 2024
Registry last updated: Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed