Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-03 @ 9:23 PM
Study NCT ID:
NCT03907657
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2019-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Contrast-enhanced Ultrasound as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C042852', 'term': 'perflutren'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'melahat.garipagaoglu@gmail.com', 'phone': '9199620000', 'title': 'Melahat Canter', 'organization': 'University of North Carolina Lineberger Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 1 day', 'description': 'Adverse events were collected from day one of the study contrast agent administration.', 'eventGroups': [{'id': 'EG000', 'title': 'Patients With a Genetic Disease at Risk of Kidney Lesions', 'description': 'Patients with a genetic disease at risk of kidney lesions will be imaged using contrast-enhanced ultrasound with Perflutren.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Comparison in Radiologist's Lesion Evaluation: CEUS Versus B-mode Ultrasound", 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'Overall Number of Kidneys', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CEUS', 'description': 'Contrast-enhanced ultrasound (CEUS) technique was used to evaluate 29 kidneys belonging to 15 subjects.'}, {'id': 'OG001', 'title': 'B-Mode', 'description': 'Brightness Mode Ultrasound (B-mode) technique was used to evaluate 29 kidneys belonging to 15 subjects.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.20', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Each reader will evaluate kidney imaging using Contrast-Enhanced Ultrasound (CEUS) versus Brightness Mode Ultrasound (B-mode) in patients at risk for kidney lesions. A dichotomized Bosniak score was used for comparison. Dichotomized Bosniak score: 0= nonmalignant and 1=malignant or possibly malignant. Scores were averaged across all readers. Kidneys were assessed by CEUS and B-mode by three different readers.', 'unitOfMeasure': 'Dichotomized score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Overall Number of Kidneys', 'denomUnitsSelected': 'Overall Number of Kidneys', 'populationDescription': 'Patients with a genetic disease at risk of a kidney lesion were imaged using contrast-enhanced ultrasound with Perflutren and B-mode ultrasound. Twenty- nine kidneys belonging to fifteen patients were assessed.'}, {'type': 'SECONDARY', 'title': "Comparison in Radiologist's Lesion Evaluation: CEUS Versus Clinically Performed MRI", 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'Overall Number of Kidneys', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CEUS', 'description': 'Contrast-enhanced ultrasound (CEUS) technique was used to evaluate 29 kidneys belonging to 15 subjects.'}, {'id': 'OG001', 'title': 'Magnetic Resonance Imaging', 'description': 'Magnetic Resonance Imaging was used to evaluate 29 kidneys belonging to 15 subjects.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Each reader will evaluate kidney imaging using Contrast-Enhanced Ultrasound (CEUS). Potentially malignant lesions were extracted from clinically performed magnetic resonance imaging (MRI) completed within 4 months of CEUS. Dichotomized Bosniak scores from CEUS were compared with MRI-derived malignancy scores.\n\nDichotomized Bosniak scores: 0= nonmalignant and 1=malignant or possibly malignant. Scores were averaged across all readers.', 'unitOfMeasure': 'Dichotomized score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Overall Number of Kidneys', 'denomUnitsSelected': 'Overall Number of Kidneys', 'populationDescription': 'Patients with a genetic disease at risk of kidney lesions will be imaged using contrast-enhanced ultrasound with Perflutren.Twenty- nine kidneys belonging to fifteen patients were assessed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Subjects', 'description': 'All Patients with genetic diseases at risk of kidney lesions.'}], 'periods': [{'title': 'Overall Study Subjects', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'CEUS', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'B Mode', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Subjects were enrolled in one center in North Carolina, between 9/23/2019 - 02/13/2023. All considered subjects were eligible, consented, and completed the study. In total 29 kidneys were studied.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With a Genetic Disease at Risk of Kidney Lesions', 'description': 'Patients with a genetic disease at risk of kidney lesions will be imaged using contrast-enhanced ultrasound with Perflutren.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Patients with a genetic disease at risk of kidney lesions will be imaged using contrast-enhanced ultrasound with Perflutren and their clinical MRI images performed within 4 months.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-18', 'size': 874244, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-21T13:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-16', 'studyFirstSubmitDate': '2019-04-05', 'resultsFirstSubmitDate': '2024-02-27', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-16', 'studyFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Comparison in Radiologist's Lesion Evaluation: CEUS Versus B-mode Ultrasound", 'timeFrame': 'Baseline', 'description': 'Each reader will evaluate kidney imaging using Contrast-Enhanced Ultrasound (CEUS) versus Brightness Mode Ultrasound (B-mode) in patients at risk for kidney lesions. A dichotomized Bosniak score was used for comparison. Dichotomized Bosniak score: 0= nonmalignant and 1=malignant or possibly malignant. Scores were averaged across all readers. Kidneys were assessed by CEUS and B-mode by three different readers.'}], 'secondaryOutcomes': [{'measure': "Comparison in Radiologist's Lesion Evaluation: CEUS Versus Clinically Performed MRI", 'timeFrame': 'Baseline', 'description': 'Each reader will evaluate kidney imaging using Contrast-Enhanced Ultrasound (CEUS). Potentially malignant lesions were extracted from clinically performed magnetic resonance imaging (MRI) completed within 4 months of CEUS. Dichotomized Bosniak scores from CEUS were compared with MRI-derived malignancy scores.\n\nDichotomized Bosniak scores: 0= nonmalignant and 1=malignant or possibly malignant. Scores were averaged across all readers.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Von-Hippel Lindau', 'Kidney Disease, Chronic']}, 'referencesModule': {'references': [{'pmid': '34783716', 'type': 'DERIVED', 'citation': 'Larcher A, Rowe I, Belladelli F, Fallara G, Raggi D, Necchi A, Montorsi F, Capitanio U, Salonia A; OSR VHL Program. Von Hippel-Lindau disease-associated renal cell carcinoma: a call to action. Curr Opin Urol. 2022 Jan 1;32(1):31-39. doi: 10.1097/MOU.0000000000000950.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if contrast-enhanced ultrasound can detect abnormal features of kidney lesions in patients with Von-Hippel Lindau with the same accuracy as conventional ultrasound and contrast-enhanced magnetic resonance imaging (MRI)', 'detailedDescription': 'This is a pilot cross-sectional study that compares contrast enhanced ultrasound to conventional ultrasound and contrasted MRI. Any patient undergoing annual imaging screening is eligible, but the investigators will target inclusion of at least 10 subjects who have at least 1 kidney lesion. Therefore, up to 5 subjects may have no current kidney lesions. Subject participation will be only for the day of CEUS study. There will be no follow-up period for this study. However, if results are encouraging, a longitudinal observational study may follow, and these same subjects would be eligible for enrollment. Eligible subjects will undergo a contrast enhanced ultrasound.\n\nFollowing completion of imaging, all CEUS, MRI (within 4 months) and B-mode (at time of CEUS) US studies will be de-identified. Blinded radiologists will interpret images and provide an overall assessment of risk of malignancy to each kidney using the Bosniak criteria for each kidney lesion present. The Bosniak criteria places cystic lesions into one of 5 categories (I, II, IIF, III and IV) based on lesion characteristics. CEUS based diagnosis will be compared to the diagnoses on routine B-mode US and contrast-enhanced MRI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo be eligible for the present study, patients must meet the following criteria:\n\n1. Able to provide written informed consent\n2. Willing to comply with protocol requirements\n3. At least 16 years of age\n4. Carry a diagnosis of VHL and able to undergo routine clinical screening tests for RCC\n\nExclusion Criteria:\n\n1. Critically ill or medically unstable or in an intensive care setting and whose critical course during the observation period would be unpredictable\n2. Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®) or sulfur hexafluoride (Lumason®)\n3. Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure \\>90mmHg), or adult respiratory distress syndrome\n4. Active cardiac disease including any of the following:\n\n A. Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association) B.Unstable angina. C.Symptomatic arrhythmia (i.e. tachycardia, bradycardia, supraventricular tachycardia, ventricular fibrillation, ventricular tachycardia, atrial flutter or fibrillation).\n\n D.Myocardial infarction within 14 days prior to the date of proposed microbubble administration.\n5. Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives such as:\n\n * Mental illness\n * Drug abuse\n6. Female patient who is pregnant or lactating\n7. Obesity that limits obtainment of acceptable images'}, 'identificationModule': {'nctId': 'NCT03907657', 'acronym': 'CEUS-VHL', 'briefTitle': 'Contrast-enhanced Ultrasound as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'Double-Center Cross-Sectional Study of Contrast-Enhanced Ultrasound With Lumason/Definity as a Screening Tool for Kidney Cancer in Patients With Von-Hippel Lindau', 'orgStudyIdInfo': {'id': 'LCCC1824'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Perflutren Lipid Microsphere or Lumason', 'description': 'Patients with Von-Hippel Lindau disease will be imaged using contrast-enhanced ultrasound with either perflutren or Lumason.', 'interventionNames': ['Drug: Perflutren lipid microsphere', 'Drug: Sulfur hexafluoride lipid microspheres']}], 'interventions': [{'name': 'Perflutren lipid microsphere', 'type': 'DRUG', 'otherNames': ['• Definity®', '• Microbubble contrast agent'], 'description': 'Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Perflutren is a diagnostic drug that is intended to be used for contrast enhancement. The vial contains a clear, colorless, sterile, non-pyrogenic, hypertonic solution which is activated by mechanical agitation with Vialmix®.It will be dispensed in inactivated form to a study team member. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.', 'armGroupLabels': ['Perflutren Lipid Microsphere or Lumason']}, {'name': 'Sulfur hexafluoride lipid microspheres', 'type': 'DRUG', 'otherNames': ['Lumason'], 'description': 'Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Lumason will be used as a secondary contrast agent only if Definity(perflutren) is unavailable.This drug will be administered using the dosing range and administration type within the Lumason prescribing information. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.', 'armGroupLabels': ['Perflutren Lipid Microsphere or Lumason']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599-7510', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina of Chapel hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Emily Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lantheus Medical Imaging', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}