[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658182":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":36,"studyPopulation":29,"armGroups":37,"interventions":44,"overallOfficials":51,"centralContacts":56,"locations":29,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":29,"eligibilityCriteria":73,"healthyVolunteers":70,"sex":74,"minAge":75,"maxAge":29,"enrollmentInfo":76,"targetDuration":29,"studyType":79,"phases":80,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":92,"whyStopped":29,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":29},{"fullName":5,"class":6},"Thomas Jefferson University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":29},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"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.","Up to 1 year after CEUS examination",{"measure":14,"description":15,"timeFrame":12},"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.",{"measure":17,"description":18,"timeFrame":12},"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.",{"measure":20,"description":21,"timeFrame":12},"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.",[23,26],{"measure":24,"description":25,"timeFrame":12},"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.",{"measure":27,"description":28,"timeFrame":12},"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 (\\\u003C 0.20), fair (0.21-0.40), moderate (0.41-0.60), substantial (0.61-0.80), and almost perfect (0.81-1.00).",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":35,"maskingDescription":29,"whoMasked":29},"NONE","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\u002Fadnexal lesions. Once properly validated, CEUS is expected to improve patient outcomes by offering a viable tool for ovarian\u002Fadnexal lesion characterization, enabling earlier and more precise diagnosis of malignancy in our patients.\n\nCurrent 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\u002Fadnexal 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.\n\nPatients will first undergo baseline transabdominal and transvaginal US imaging. B-mode measurements and sweeps of the ovarian\u002Fadnexal 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.\n\nThe 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.\n\nDuring 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.\n\nPrimary:\n\n• To evaluate the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of qualitative CEUS biomarkers for diagnosing ovarian cancer.\n\nSecondary:\n\n* To evaluate the reproducibility and inter-reader reliability of qualitative CEUS biomarkers for ovarian cancer diagnosis.\n* To prospectively evaluate the diagnostic performance of a multimodal model for ovarian cancer diagnosis.",[38],{"label":39,"type":40,"description":41,"interventionNames":42},"Contrast-Enhanced Ultrasound (CEUS)","EXPERIMENTAL","Participants with indeterminate or suspicious ovarian\u002Fadnexal 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.\n\nDuring 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.",[43],"Diagnostic Test: Contrast-Enhanced Ultrasound (CEUS)",[45],{"type":46,"name":39,"description":47,"armGroupLabels":48,"otherNames":49},"DIAGNOSTIC_TEST","Participants will undergo contrast-enhanced ultrasound (CEUS) imaging of the ovarian\u002Fadnexal 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.",[39],[50],"CEUS",[52],{"name":53,"affiliation":54,"role":55},"Andrej Lyshchik, MD, PhD","Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University","PRINCIPAL_INVESTIGATOR",[57],{"name":58,"role":59,"phone":60,"phoneExt":29,"email":61},"Site Public Contact","CONTACT","215-600-9151","ONCTrialNow@jefferson.edu",{"type":63,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[65],{"name":66,"class":67},"National Cancer Institute (NCI)","NIH","100658182","contrast-enhanced-ultrasound-evaluation-of-indeterminate-ovarian-lesions-prospective-multicenter-study-100658182",false,"NCT07849543","Contrast-enhanced Ultrasound Evaluation of Indeterminate Ovarian Lesions: Prospective Multicenter Study","Inclusion Criteria:\n\n* All subjects accepted for this trial must be:\n\n  * Patients ≥ 18 years of age.\n  * Capable of making informed decisions regarding her treatment.\n  * Have an ovarian or adnexal lesion categorized as O-RADS US 3-5 on conventional US, OR\n  * Have an ovarian or adnexal lesion categorized as O-RADS MRI 3-5 on pelvic MRI\n\nExclusion Criteria:\n\n* Subjects with any of the following will be excluded from this trial:\n\n  * Patients with physiological or definitely benign ovarian or adnexal lesions (O-RADS 1-2).\n  * Patients who are pregnant or lactating.\n  * Patients with ovarian or adnexal lesions less than 1 cm or greater than 15 cm in size.\n  * Patients with contraindications to CEUS.\n  * Patients who are medically unstable, terminally ill, or whose clinical course is unpredictable.","FEMALE","18 Years",{"count":77,"type":78},190,"ESTIMATED","INTERVENTIONAL",[31],"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\u002Fadnexal lesions identified on routine ultrasound or MRI.\n\nThe main questions it aims to answer are:\n\nHow accurately can qualitative CEUS imaging features distinguish malignant from benign ovarian\u002Fadnexal lesions?\n\nHow consistent are the CEUS assessments among different readers, and can combining CEUS findings with MRI and clinical information improve diagnostic performance?\n\nParticipants will:\n\nUndergo a baseline pelvic ultrasound followed by CEUS imaging using an intravenous ultrasound contrast agent.\n\nReceive a second contrast injection during the same examination so that additional CEUS images can be obtained.\n\nBe followed for up to 1 year, with standard-of-care imaging or pathology used as the reference for determining whether the ovarian\u002Fadnexal lesion is benign or malignant.",[83,84],"Ovarian Cancer","Adnexal Lesion",[86,50,83,87,88,89,90,91],"Contrast-enhanced ultrasound","Ovarian Lesions","Adnexal Lesions","O-RADS US 3-5","O-RADS MRI 3-5","contrast-enhanced MRI","NOT_YET_RECRUITING","2026-09-24",{"date":95,"type":96},"2026-09-30","ACTUAL",{"date":98,"type":78},"2026-10",{"date":100,"type":78},"2031-07",{"name":5,"class":6}]