Contribution of Contrast Enhanced Ultrasound in the Diagnosis of Adnexal Torsion

NCT04522219 | Terminated Phase 3 DMC

• 1 other identifier: 2020-000993-27
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adnexal Torsion

Keywords

adnexal; torsion; ovarian; contrast enhanced ultrasound

Outcome Measures

Primary Outcomes (1)

• Signal intensity measurement

  to assess sensitivity, specificity, positive and negative predictive value of contrast enhanced ultrasound for detection of adnexal torsion in women with suspected adnexal torsion with realization of ROC curves

  through study completion, on average of 36 months

Secondary Outcomes (7)

• vascularization of the ovaries on contrast enhanced ultrasound.

  through study completion, an average of 36 months

• diagnostics performance

  through study completion, an average of 36 months

• vascularization of the ovaries according to the degree of torsion

  through study completion, an average of 36 months

• vascularization of the ovaries before and after detorsion

  through study completion, an average of 36 months

• Micro Vascular Flow technique

  through study completion, an average of 36 months

Study Arms (2)

Case group

EXPERIMENTAL

Diagnosis of adnexal torsion confirmed by the surgical intervention: woman allocated to case group

Diagnostic Test: Contrast enhanced ultrasound

Control group

EXPERIMENTAL

Diagnosis of adnexal torsion not confirmed by the surgical intervention: woman allocated to control group

Diagnostic Test: Contrast enhanced ultrasound

Interventions

Contrast enhanced ultrasound DIAGNOSTIC_TEST

Acquisition of contrast enhanced ultrasound. Contrast agent: SonoVue®: Hexafluoride (SonoVue®, injectable solution to solubilisate, 8µg/mL) is injected in all patients

Case group; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman over 18 years old
• Woman affiliated to a social security
• Woman having received complete information on the organization of the research and having given her informed consent in written form.
• Planned surgical intervention for suspected adnexal torsion

You may not qualify if:

• Patients under a measure of legal protection,
• Contraindication to contrast injection Hypersensitivity to sulfur hexafluoride or any of the other ingredients, history of cardiac disease, respiratory distress syndrome, severe pulmonary hypertension..

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre Hospitalier Régional Universitaire de Nancy

Nancy, 54000, France

Location

Related Publications (2)

• Pillot R, Hossu G, Cherifi A, Guillez K, Morel O, Beaumont M, Fijean AL, Bertholdt C. Contribution of contrast-enhanced ultrasound in the diagnosis of adnexal torsion (AGATA): protocol for a prospective comparative study. BMJ Open. 2023 Aug 24;13(8):e073301. doi: 10.1136/bmjopen-2023-073301.

  PMID: 37620263 BACKGROUND

• Fijean AL, Hossu G, Cherifi A, Beaumont M, Morel O, Bertholdt C. Improving diagnostic accuracy of ovarian torsion using contrast-enhanced ultrasound: A prospective comparative clinical study of performance diagnosis. Int J Gynaecol Obstet. 2026 Feb;172(2):1151-1158. doi: 10.1002/ijgo.70429. Epub 2025 Aug 5.

  PMID: 40761032 RESULT

MeSH Terms

Conditions

Ovarian Torsion

Condition Hierarchy (Ancestors)

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

Study Officials

• Charline BERTHOLDT

  Central Hospital, Nancy, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator (Obstetrician, Medical Doctor)

Model Details: Phase 3b, prospective, Case-Control study

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: August 21, 2020
• Study Start: April 13, 2021
• Primary Completion: August 17, 2022
• Study Completion: June 5, 2023
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

FR (1)