Ovarian CancerNCT07849543
Contrast-enhanced Ultrasound Evaluation of Indeterminate Ovarian Lesions: Prospective Multicenter Study
A study testing Contrast-Enhanced Ultrasound (CEUS) in people with Ovarian Cancer and Adnexal Lesion, run by Thomas Jefferson University.
Trial summary
The goal of this clinical trial is to learn how well contrast-enhanced ultrasound (CEUS) can diagnose ovarian cancer in patients with indeterminate or suspicious ovarian/adnexal lesions identified on routine ultrasound or MRI. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Adnexal Lesion
- What is being tested?
- Contrast-Enhanced Ultrasound (CEUS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects accepted for this trial must be:
- Patients ≥ 18 years of age.
- Capable of making informed decisions regarding her treatment.
- Have an ovarian or adnexal lesion categorized as O-RADS US 3-5 on conventional US, OR
- Have an ovarian or adnexal lesion categorized as O-RADS MRI 3-5 on pelvic MRI
Who cannot join
- Subjects with any of the following will be excluded from this trial:
- Patients with physiological or definitely benign ovarian or adnexal lesions (O-RADS 1-2).
- Patients who are pregnant or lactating.
- Patients with ovarian or adnexal lesions less than 1 cm or greater than 15 cm in size.
- Patients with contraindications to CEUS.
- Patients who are medically unstable, terminally ill, or whose clinical course is unpredictable.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to learn how well contrast-enhanced ultrasound (CEUS) can diagnose ovarian cancer in patients with indeterminate or suspicious ovarian/adnexal lesions identified on routine ultrasound or MRI.
The main questions it aims to answer are:
Read more
How accurately can qualitative CEUS imaging features distinguish malignant from benign ovarian/adnexal lesions?
How consistent are the CEUS assessments among different readers, and can combining CEUS findings with MRI and clinical information improve diagnostic performance?
Participants will:
Undergo a baseline pelvic ultrasound followed by CEUS imaging using an intravenous ultrasound contrast agent.
Receive a second contrast injection during the same examination so that additional CEUS images can be obtained.
Be followed for up to 1 year, with standard-of-care imaging or pathology used as the reference for determining whether the ovarian/adnexal lesion is benign or malignant.
Read the detailed description
This project introduces several groundbreaking advancements to ovarian cancer diagnosis: first prospective validation of contrast-enhanced ultrasound (CEUS) biomarkers in ovarian cancer based on unique ability of CEUS to detect malignant neovascularity: addressing long-standing concern of variability of CEUS imaging by evaluating CEUS biomarkers reproducibility with consecutive injections and CEUS inter-reader reliability across blinded experts. The main technical innovation is the development of an innovative CEUS Quantitative Statistical Features to further improve categorization of indeterminate ovarian/adnexal lesions. Once properly validated, CEUS is expected to improve patient outcomes by offering a viable tool for ovarian/adnexal lesion characterization, enabling earlier and more precise diagnosis of malignancy in our patients.
Current imaging modalities for evaluating ovarian lesions include endovaginal ultrasound (EVUS) and contrast-enhanced magnetic resonance imaging (MRI), with lesion categorization guided by the American College of Radiology (ACR) Ovarian-Adnexal Reporting and Data System (O-RADS) providing 75% sensitivity and 92% specificity for ovarian cancer (2). In the majority of cases, lesions are classified as benign (O-RADS 1, 2), nonetheless, a substantial proportion fall into indeterminate or suspicious categories (O-RADS 3, 4, 5), often requiring additional imaging follow-up or surgical excision for definitive characterization. The subject population will include patients with indeterminate or suspicious ovarian/adnexal lesions detected with ultrasound (US) (O-RADS US 3-5) or contrast-enhanced MRI (O-RADS MRI 3-5) performed as part of their clinical standard of care.
Patients will first undergo baseline transabdominal and transvaginal US imaging. B-mode measurements and sweeps of the ovarian/adnexal lesion in the transverse and sagittal planes will be acquired. Color Doppler images will be acquired to assess lesion vascularity. Following baseline imaging, patients will receive a bolus IV injection of US contrast, followed by a normal saline flush.
The US contrast agent will be administered by bolus intravenous injection through a 18-22 Gauge angiocatheter placed in a peripheral arm vein ultrasound contrast agent, as per manufacturer's guidelines. During a single examination, a second injection will be administered, and imaging repeated using the same or different transducer.
During the contrast injection the approximate lesion mid-line or the most vascular portion of the lesion will be imaged until homogenous enhancement is achieved (approximately 30-60 seconds post injection), followed by imaging sweeps through the lesion.. After that, intermittent imaging will be continued for 3 minutes, after which data will be digitally stored for later review.
Primary:
- To evaluate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of qualitative CEUS biomarkers for diagnosing ovarian cancer.
Secondary:
- To evaluate the reproducibility and inter-reader reliability of qualitative CEUS biomarkers for ovarian cancer diagnosis.
- To prospectively evaluate the diagnostic performance of a multimodal model for ovarian cancer diagnosis.
- Conditions
- Ovarian Cancer, Adnexal Lesion
- Being tested
- Contrast-Enhanced Ultrasound (CEUS)
- Keywords
- Contrast-enhanced ultrasound, CEUS, Ovarian Cancer, Ovarian Lesions, Adnexal Lesions, O-RADS US 3-5, O-RADS MRI 3-5, contrast-enhanced MRI
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-Enhanced Ultrasound (CEUS)Diagnostic test
Also called CEUS
Participants will undergo contrast-enhanced ultrasound (CEUS) imaging of the ovarian/adnexal lesion. Lumason or Definity will be administered by intravenous bolus injection, followed by a saline flush. CEUS imaging will be performed following contrast administration. A second contrast injection will be administered during the same examination for repeat CEUS imaging.
| Study group | Role | What they receive |
|---|---|---|
| Contrast-Enhanced Ultrasound (CEUS) | Experimental | Participants with indeterminate or suspicious ovarian/adnexal lesions identified on routine US or MRI will undergo CEUS examinations within 2 months after their standard of care imaging or within 2 months prior to their standard of care surgery. The US contrast agent will be administered by bolus intravenous injection through a 18-22 Gauge angiocatheter placed in a peripheral arm vein ultrasound contrast agent, as per manufacturer's guidelines. During a single examination, a second injection will be administered, and imaging repeated using the same or different transducer.
During the contrast injection the approximate lesion mid-line or the most vascular portion of the lesion will be imaged until homogenous enhancement is achieved (approximately 30-60 seconds post injection), followed by imaging sweeps through the lesion.. After that, intermittent imaging will be continued for 3 minutes, after which data will be digitally stored for later review. Receives: Diagnostic Test: Contrast-Enhanced Ultrasound (CEUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Ovarian Cancer Correctly Identified as Positive by Qualitative CEUS Biomarkers (Sensitivity)
Sensitivity will be calculated for CEUS biomarkers compared to the composite reference standard (histopathology or follow-up imaging). Exact binomial confidence intervals (95%) will be calculated for all performance metrics. CEUS biomarker performance will be compared to standard MRI using McNemar's test for paired proportions.
Measured: Up to 1 year after CEUS examination
Percentage of Participants Without Ovarian Cancer Correctly Identified as Negative by Qualitative CEUS Biomarkers (Specificity)
Specificity will be calculated for CEUS biomarkers compared to the composite reference standard (histopathology or follow-up imaging). Exact binomial confidence intervals (95%) will be calculated for all performance metrics. CEUS biomarker performance will be compared to standard MRI using McNemar's test for paired proportions.
Measured: Up to 1 year after CEUS examination
Percentage of Participants Classified as Positive by Qualitative CEUS Biomarkers Who are Confirmed to Have Confirmed to have Ovarian Cancer (Positive Predictive Value-PPV)
Positive Predictive Value (PPV) will be calculated for CEUS biomarkers compared to the composite reference standard (histopathology or follow-up imaging). Exact binomial confidence intervals (95%) will be calculated for all performance metrics. CEUS biomarker performance will be compared to standard MRI using McNemar's test for paired proportions.
Measured: Up to 1 year after CEUS examination
Percentage of Participants Classified as Negative by Qualitative CEUS Biomarkers Who are Confirmed Not to Have Ovarian Cancer (Negative Predictive Value-NPV)
Negative Predictive Value (NPV) will be calculated for CEUS biomarkers compared to the composite reference standard (histopathology or follow-up imaging). Exact binomial confidence intervals (95%) will be calculated for all performance metrics. CEUS biomarker performance will be compared to standard MRI using McNemar's test for paired proportions.
Measured: Up to 1 year after CEUS examination
Secondary outcomes (2)
Reproducibility of CEUS biomarkers for ovarian cancer
Intraclass correlation coefficient (ICC) will assess the agreement between both injections at the same examination and between initial and repeat evaluations of CEUS biomarkers by the same reader after six months.
Measured: Up to 1 year after CEUS examination
Inter-Reader Reliability of CEUS biomarkers for ovarian cancer
Cohen's kappa will be calculated for each pair of readers to assess pairwise agreement. Fleiss' kappa will be used to assess overall agreement across all 5 readers. Kappa values will be interpreted using the following thresholds: poor (< 0.20), fair (0.21-0.40), moderate (0.41-0.60), substantial (0.61-0.80), and almost perfect (0.81-1.00).
Measured: Up to 1 year after CEUS examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionJan 2031 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Andrej Lyshchik, MD, PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849543
- Sponsor's protocol ID
- 2026-0575
- Other IDs
- R01CA308347, JT 48874
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-enhanced Ultrasound Evaluation of Indeterminate Ovarian Lesions: Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT07849543
- Acronym / sponsor ID
- 2026-0575
- Conditions
- Ovarian Cancer, Adnexal Lesion
- Keywords
- Contrast-enhanced ultrasound, CEUS, Ovarian Cancer, Ovarian Lesions, Adnexal Lesions, O-RADS US 3-5, O-RADS MRI 3-5, contrast-enhanced MRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn how well contrast-enhanced ultrasound (CEUS) can diagnose ovarian cancer in patients with indeterminate or suspicious ovarian/adnexal lesions identified on routine ultrasound or MRI.
The main questions it aims to answer are:
How accurately can qualitative CEUS imaging features distinguish malignant from benign ovarian/adnexal lesions?
How consistent are the CEUS assessments among different readers, and can combining CEUS findings with MRI and clinical information improve diagnostic performance?
Participants will:
Undergo a baseline pelvic ultrasound followed by CEUS imaging using an intravenous ultrasound contrast agent.
Receive a second contrast injection during the same examination so that additional CEUS images can be obtained.
Be followed for up to 1 year, with standard-of-care imaging or pathology used as the reference for determining whether the ovarian/adnexal lesion is benign or malignant.
Detailed description
This project introduces several groundbreaking advancements to ovarian cancer diagnosis: first prospective validation of contrast-enhanced ultrasound (CEUS) biomarkers in ovarian cancer based on unique ability of CEUS to detect malignant neovascularity: addressing long-standing concern of variability of CEUS imaging by evaluating CEUS biomarkers reproducibility with consecutive injections and CEUS inter-reader reliability across blinded experts. The main technical innovation is the development of an innovative CEUS Quantitative Statistical Features to further improve categorization of indeterminate ovarian/adnexal lesions. Once properly validated, CEUS is expected to improve patient outcomes by offering a viable tool for ovarian/adnexal lesion characterization, enabling earlier and more precise diagnosis of malignancy in our patients.
Current imaging modalities for evaluating ovarian lesions include endovaginal ultrasound (EVUS) and contrast-enhanced magnetic resonance imaging (MRI), with lesion categorization guided by the American College of Radiology (ACR) Ovarian-Adnexal Reporting and Data System (O-RADS) providing 75% sensitivity and 92% specificity for ovarian cancer (2). In the majority of cases, lesions are classified as benign (O-RADS 1, 2), nonetheless, a substantial proportion fall into indeterminate or suspicious categories (O-RADS 3, 4, 5), often requiring additional imaging follow-up or surgical excision for definitive characterization. The subject population will include patients with indeterminate or suspicious ovarian/adnexal lesions detected with ultrasound (US) (O-RADS US 3-5) or contrast-enhanced MRI (O-RADS MRI 3-5) performed as part of their clinical standard of care.
Patients will first undergo baseline transabdominal and transvaginal US imaging. B-mode measurements and sweeps of the ovarian/adnexal lesion in the transverse and sagittal planes will be acquired. Color Doppler images will be acquired to assess lesion vascularity. Following baseline imaging, patients will receive a bolus IV injection of US contrast, followed by a normal saline flush.
The US contrast agent will be administered by bolus intravenous injection through a 18-22 Gauge angiocatheter placed in a peripheral arm vein ultrasound contrast agent, as per manufacturer's guidelines. During a single examination, a second injection will be administered, and imaging repeated using the same or different transducer.
During the contrast injection the approximate lesion mid-line or the most vascular portion of the lesion will be imaged until homogenous enhancement is achieved (approximately 30-60 seconds post injection), followed by imaging sweeps through the lesion.. After that, intermittent imaging will be continued for 3 minutes, after which data will be digitally stored for later review.
Primary:
- To evaluate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of qualitative CEUS biomarkers for diagnosing ovarian cancer.
Secondary:
- To evaluate the reproducibility and inter-reader reliability of qualitative CEUS biomarkers for ovarian cancer diagnosis.
- To prospectively evaluate the diagnostic performance of a multimodal model for ovarian cancer diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast-Enhanced Ultrasound (CEUS) | Experimental | Diagnostic Test: Contrast-Enhanced Ultrasound (CEUS)Participants with indeterminate or suspicious ovarian/adnexal lesions identified on routine US or MRI will undergo CEUS examinations within 2 months after their standard of care imaging or within 2 months prior to their standard of care surgery. The US contrast agent will be administered by bolus intravenous injection through a 18-22 Gauge angiocatheter placed in a peripheral arm vein ultrasound contrast agent, as per manufacturer's guidelines. During a single examination, a second injection will be administered, and imaging repeated using the same or different transducer. During the contrast injection the approximate lesion mid-line or the most vascular portion of the lesion will be imaged until homogenous enhancement is achieved (approximately 30-60 seconds post injection), followed by imaging sweeps through the lesion.. After that, intermittent imaging will be continued for 3 minutes, after which data will be digitally stored for later review. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All subjects accepted for this trial must be:
Key exclusion criteria (6 listed)
- Subjects with any of the following will be excluded from this trial:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast-Enhanced Ultrasound (CEUS)Also: CEUSParticipants will undergo contrast-enhanced ultrasound (CEUS) imaging of the ovarian/adnexal lesion. Lumason or Definity will be administered by intravenous bolus injection, followed by a saline flush. CEUS imaging will be performed following contrast administration. A second contrast injection will be administered during the same examination for repeat CEUS imaging. | Diagnostic test | Contrast-Enhanced Ultrasound (CEUS) |
Primary outcome
Percentage of Participants with Ovarian Cancer Correctly Identified as Positive by Qualitative CEUS Biomarkers (Sensitivity)
Time frame: Up to 1 year after CEUS examination
Sensitivity will be calculated for CEUS biomarkers compared to the composite reference standard (histopathology or follow-up imaging). Exact binomial confidence intervals (95%) will be calculated for all performance metrics. CEUS biomarker performance will be compared to standard MRI using McNemar's test for paired proportions.
Percentage of Participants Without Ovarian Cancer Correctly Identified as Negative by Qualitative CEUS Biomarkers (Specificity)
Time frame: Up to 1 year after CEUS examination
Specificity will be calculated for CEUS biomarkers compared to the composite reference standard (histopathology or follow-up imaging). Exact binomial confidence intervals (95%) will be calculated for all performance metrics. CEUS biomarker performance will be compared to standard MRI using McNemar's test for paired proportions.
Percentage of Participants Classified as Positive by Qualitative CEUS Biomarkers Who are Confirmed to Have Confirmed to have Ovarian Cancer (Positive Predictive Value-PPV)
Time frame: Up to 1 year after CEUS examination
Positive Predictive Value (PPV) will be calculated for CEUS biomarkers compared to the composite reference standard (histopathology or follow-up imaging). Exact binomial confidence intervals (95%) will be calculated for all performance metrics. CEUS biomarker performance will be compared to standard MRI using McNemar's test for paired proportions.
Percentage of Participants Classified as Negative by Qualitative CEUS Biomarkers Who are Confirmed Not to Have Ovarian Cancer (Negative Predictive Value-NPV)
Time frame: Up to 1 year after CEUS examination
Negative Predictive Value (NPV) will be calculated for CEUS biomarkers compared to the composite reference standard (histopathology or follow-up imaging). Exact binomial confidence intervals (95%) will be calculated for all performance metrics. CEUS biomarker performance will be compared to standard MRI using McNemar's test for paired proportions.
2 secondary outcomes
Reproducibility of CEUS biomarkers for ovarian cancer
Time frame: Up to 1 year after CEUS examination
Inter-Reader Reliability of CEUS biomarkers for ovarian cancer
Time frame: Up to 1 year after CEUS examination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrej Lyshchik, MD, PhD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Questions about this trial
What is this clinical trial studying?
A study testing Contrast-Enhanced Ultrasound (CEUS) in people with Ovarian Cancer and Adnexal Lesion, run by Thomas Jefferson University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Site Public Contact (215-600-9151, ONCTrialNow@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Ovarian Cancer Correctly Identified as Positive by Qualitative CEUS Biomarkers (Sensitivity) (time frame: Up to 1 year after CEUS examination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.