Contribution of Contrast Enhanced Ultrasound for Diagnosis of Adnexal Torsion

Launched by CENTRAL HOSPITAL, NANCY, FRANCE · Nov 5, 2024

Keywords

ClinConnect Summary

The COVARIAN clinical trial is studying how adding a special type of ultrasound, called contrast-enhanced ultrasound, can help doctors diagnose adnexal torsion more accurately. Adnexal torsion is a serious condition where the ovary twists, cutting off its blood supply, which can lead to severe pain and potential loss of fertility if not treated quickly. Currently, diagnosing this condition can be tricky, and many women may undergo unnecessary surgery. The trial hopes to show that using contrast-enhanced ultrasound can reduce the number of women who are mistakenly diagnosed with adnexal torsion and end up having surgery they don’t need.

To participate in this trial, women aged 18 and older who have strong signs of adnexal torsion and are scheduled for surgery may be eligible. Participants will undergo the standard ultrasound and the new contrast-enhanced ultrasound to see if it improves the accuracy of the diagnosis. This is an important step in advancing care for women facing this emergency condition, as it aims to ensure that only those truly needing surgery are treated. The trial is not yet recruiting participants, but it represents a promising approach to improving women's health in this area.

Gender

FEMALE

Eligibility 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