Using contrast-enhanced ultrasound to diagnose adnexal torsion
COVARIAN - Contribution of Contrast Enhanced Ultrasound for Diagnosis of Adnexal Torsion: a Randomized Controlled Trial
PHASE3 · Central Hospital, Nancy, France · NCT06677554
This study is testing if a special ultrasound can help doctors better diagnose adnexal torsion in women who might need surgery.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Central Hospital, Nancy, France (other) |
| Locations | 6 sites (Besançon and 5 other locations) |
| Trial ID | NCT06677554 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of contrast-enhanced ultrasound using SonoVue® in diagnosing adnexal torsion, a gynecological emergency that can lead to severe complications if not treated promptly. The study aims to improve diagnostic accuracy compared to standard pelvic ultrasound and Doppler flow analysis, which have shown variable sensitivity. Participants will undergo the contrast-enhanced ultrasound in addition to standard care, with the goal of providing a more definitive diagnosis before surgical intervention. The trial is designed for women with a strong suspicion of adnexal torsion who are scheduled for surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and over with a strong suspicion of adnexal torsion who are scheduled for surgical intervention.
Not a fit: Patients who may not benefit from this study include those with contraindications to SonoVue® or those who do not understand or speak French.
Why it matters
Potential benefit: If successful, this approach could lead to quicker and more accurate diagnoses of adnexal torsion, potentially improving patient outcomes and preserving fertility.
How similar studies have performed: While there is limited data on the use of contrast-enhanced ultrasound for this specific condition, similar imaging techniques have shown promise in improving diagnostic accuracy in other medical contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Besançon and 5 other locations
- CHU — Besançon, France (NOT_YET_RECRUITING)
- CHU — Dijon, France (NOT_YET_RECRUITING)
- CHRU Nancy - Maternité Régionale — Nancy, France (RECRUITING)
- CHU — Reims, France (NOT_YET_RECRUITING)
- CMCO — Schiltigheim, France (NOT_YET_RECRUITING)
- CHU Hautepierre — Strasbourg, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Charline BERTHOLDT, Pr — CHRU Nancy
- Study coordinator: Charline BERTHOLDT, Pr
- Email: c.bertholdt@chru-nancy.fr
- Phone: +33 383 344 312
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adnexal Torsion