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Study on the Use of Sulfur Hexafluoride in Ultrasound for Diagnosing Adnexal Torsion in Patients with Suspected Ovarian Twisting

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as adnexal torsion, which occurs when an ovary or fallopian tube twists, potentially cutting off its blood supply. The study will use a special imaging technique called contrast enhanced ultrasound to help diagnose this condition. The contrast agent used in this study is called SonoVue, which contains a substance known as sulfur hexafluoride. This agent is injected into the bloodstream to improve the clarity of ultrasound images.

The purpose of the study is to evaluate whether using contrast enhanced ultrasound can improve the accuracy of diagnosing adnexal torsion compared to the standard method, which does not use contrast. Participants in the study will be randomly assigned to one of two groups: one group will receive the contrast enhanced ultrasound, and the other will undergo the standard diagnostic procedure. The study aims to determine if the new method can reduce unnecessary surgeries by providing clearer diagnostic information.

Throughout the study, participants will be monitored for any immediate or delayed reactions to the contrast agent, as well as for any complications related to the condition or its treatment. The study will also track the rate of hospitalizations, consultations, and any additional surgeries needed within a month after the initial diagnosis. The goal is to gather data that could help improve the diagnostic process for adnexal torsion and potentially lead to better outcomes for patients experiencing this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose and procedures. You will need to confirm your understanding and agreement to participate by signing a consent form.

  2. Step 2

    Initial assessment

    An initial clinical examination will be conducted to confirm a strong suspicion of adnexal torsion. This is a condition where the ovary or other adnexal structures twist, potentially cutting off blood supply.

  3. Step 3

    Contrast ultrasound procedure

    If you meet the criteria, you will undergo a contrast-enhanced ultrasound. This involves the administration of a contrast agent called SonoVue, which contains sulfur hexafluoride. The contrast agent is given through an intravenous infusion to help improve the ultrasound images.

  4. Step 4

    Monitoring and evaluation

    After the ultrasound, you will be monitored for any immediate reactions to the contrast agent. This includes checking for any serious adverse events within 30 minutes of the injection and any delayed hypersensitivity reactions.

  5. Step 5

    Surgery decision

    Based on the ultrasound results, a decision will be made regarding the necessity of emergency surgery. The goal is to avoid unnecessary surgery if adnexal torsion is not confirmed.

  6. Step 6

    Follow-up

    You will have follow-up consultations to assess your recovery and any potential complications. This includes evaluating pain levels at 7 days and checking for any complications at 1 month, such as infection or the need for additional surgery.

Who can join the trial?

6 criteria

  • Must be 18 years or older.
  • Must have had a preliminary clinical examination suitable for the clinical trial.
  • Must have a strong suspicion of adnexal torsion with surgery planned. Adnexal torsion refers to the twisting of the ovary and sometimes the fallopian tube, which can cause severe pain and other symptoms.
  • Must not be pregnant or breastfeeding.
  • Must be affiliated with or a beneficiary of a social security scheme.
  • Must have received complete information about the organization of the trial.

Who cannot join the trial?

3 criteria

  • Patients who are not **female** cannot participate.
  • Patients who are not within the specified **age range** cannot participate.
  • Patients who are part of a **vulnerable population** cannot participate. A vulnerable population includes groups like children, pregnant women, or people with certain disabilities.
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Investigated drugs

The provided data does not include specific medications or therapies involved in the clinical trial. The trial focuses on evaluating a diagnostic strategy using contrast-enhanced ultrasound for diagnosing adnexal torsion. Since no medications or therapies are listed, there are no descriptions to provide.

What is already known about the treatment

The provided data does not include specific information about a medication, such as a trade name or details about its administration, status, indications, mechanism of action, or pharmacological classification. Therefore, I am unable to create a description for a medication based on the given information. If you have additional details or another request, please provide them so I can assist you further.

Investigated diseases

Adnexal torsion – Adnexal torsion is a condition where the ovary and sometimes the fallopian tube twist around the tissues that support them. This twisting can cut off the blood supply to these organs, leading to severe pain and potential damage. The condition often presents with sudden onset of lower abdominal pain, nausea, and vomiting. As the torsion progresses, the lack of blood flow can cause the affected ovary to swell and become necrotic. If left unresolved, it can lead to complications such as infection or loss of the ovary. The condition requires prompt medical attention to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511720-13-00Protocol code2021PI162Estimated enrolment256 patientsSponsorCHRU De Nancy

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