NCT04522219

Contribution of Contrast Enhanced Ultrasound in the Diagnosis of Adnexal Torsion

Contribution of Contrast Enhanced Ultrasound in the Diagnosis of Adnexal Torsion: a Prospective Comparative Study

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Adnexal Torsion

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-04-13
• Primary completion: 2022-08-17
• Completion: 2023-06-05
• First posted: 2020-08-21
• Last updated: 2026-04-08

Locations

1 site across 1 country: France