Contribution of Contrast Enhanced Ultrasound in the Diagnosis of Adnexal Torsion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-13

Study Completion Date

2023-06-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Contribution of Contrast Enhanced Ultrasound for Diagnosis of Adnexal Torsion

NCT06677554

Adnexal Torsion

RECRUITING PHASE3

Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses

NCT00248820

Ovarian Tumor

UNKNOWN NA

Ultrasound-guided Transvaginal Aspiration of Cystic Pelvic Lesions

NCT06988280

Pelvic Abscess Adnexal Cyst Ovarian Neoplasms

RECRUITING

Prospective Validation of the ADNEX Model for Discrimination Between Benign and Malignant Adnexal Masses in Pregnancy: International Ovarian Tumour Analysis in Pregnancy Study (p-IOTA)

NCT05974618

Adnexal Mass Adnexal Tumor Adnexal Cyst +1 more

RECRUITING

Effect of Fetal Ovarian Cyst Aspiration to Prevent Torsion

NCT00222066

Ovarian Cyst Ultrasonography Prenatal

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Adnexal Torsion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Phase 3b, prospective, Case-Control study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Case group

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

Group Type EXPERIMENTAL

Contrast enhanced ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Control group

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

Group Type EXPERIMENTAL

Contrast enhanced ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Contrast enhanced ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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..

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No