Adnexal torsion MedDRA version: 20.0 Level: LLT Classification code 10044069 Term: Torsion of ovary System Organ Class: 100000004872
Conditions
Interventions
Trade Name: SONOVUE
Pharmaceutical Form: Powder and solvent for dispersion for injection
INN or Proposed INN: SULPHUR HEXAFLUORIDE
CAS Number: 2551-62-4
Current Sponsor code: SONOVUE
Other descriptive
Sponsors
CHRU NANCY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 18 years Planned surgery for suspected adnexal torsion Being affiliated to the Social Security system or benefiting from such a system Have received full information about the organization of the study and have signed their informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: "Any medical condition that contraindicates the administration of SonoVue® , in particular : o Documented hypersensitivity to sulfur hexafluoride or any of the other components of SonoVue o Woman with acute coronary syndrome or unstable ischemic heart disease o Woman with acute endocarditis o Woman with prosthetic valves o Woman with acute systemic inflammatory disease and/or sepsis o Woman in a state of hypercoagulation and/or recent thromboembolic event o Woman with end-stage kidney or liver disease o Woman with right-left shunt, severe pulmonary arterial hypertension (pulmonary arterial pressure > 90 mmHg) o Woman with uncontrolled systemic hypertension o Woman with respiratory distress syndrome" "Persons referred in Articles L. 1121-5, L. 1121-7 and L1121-8 of French Public Health Code : o Pregnant woman, parturient or breastfeeding mother o Minor person (not emancipated) o Adult person under legal protection (guardianship, curatorship, legal safeguard) o Adult who is unable to give consent " Persons who are deprived of their liberty by a judicial or administrative decision, persons under psychiatric care pursuant to articles L. 3212-1 and L. 3213-1
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): CES1 : Measurement of the vascularisation parameters of the suspected torsional ovary and the contralateral ovary if available: signal intensity and perfusion kinetics. CES 2 : Measurement of signal intensities to evaluate sensitivities and specificities of contrast ultrasound and 2D Doppler ultrasound. CES3 : Comparison of ovarian vascularization parameters with the degree of adnexal torsion. The degree of torsion is defined by the number of turns (number of rotations around the axis) detected during surgery for detorsion under laparoscopy. ;Timepoint(s) of evaluation of this end point: CES1 : Day 0 (D0) CES2 : Day 0 (D0) CES3 : Day 0 (D0) | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the diagnostic performance of contrast-enhanced ultrasound for the diagnosis of adnexal torsion in women with suspected adnexal torsion.;Secondary Objective: OS1: To describe the vascularization parameters of the ovaries in contrast-enhanced ultrasound. OS2: To compare the diagnostic performance of contrast-enhanced ultrasound and 2D Doppler Ultrasound for the detection of adnexal torsion. OS3: To describe the vascular parameters of the ovary according to the degree of adnexal torsion.;Primary end point(s): "Measurement of signal intensity to assess the sensitivity, specificity, positive predictive value and negative predictive value of ultrasound with contrast agent for the detection of adnexal torsion, in women adnexal torsion suspected, with ROC (Receiver Operating Characteristics) curves. The presence or not of adnexal torsion is confirmed during surgery (or diagnostic and therapeutic laparoscopy or laparotomy = reference method)." ;Timepoint(s) of evaluation of this end point: Day 0 (D0) | — |
Countries
France
Contacts
Public ContactProject manager
CHRU NANCY
Outcome results
None listed