Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-26 @ 10:26 AM
Study NCT ID:
NCT01490892
Status:
COMPLETED
Last Update Posted:
2025-05-06
First Post:
2011-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Quantitative Subharmonic Breast Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C042852', 'term': 'perflutren'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'flemming.forsberg@jefferson.edu', 'phone': '215-955-4870', 'title': 'Dr. Flemming Forsberg', 'organization': 'Sidney Kimmel Cancer Center at Thomas Jefferson University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'baseline to 30 minutes post contrast injection for Adverse Events, All-Cause Mortality up to 1 year', 'eventGroups': [{'id': 'EG000', 'title': '3D HI and SHI of UCA', 'description': 'Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)\n\n3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)', 'otherNumAtRisk': 219, 'deathsNumAtRisk': 219, 'otherNumAffected': 0, 'seriousNumAtRisk': 219, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '3D HI and SHI of UCA', 'description': 'Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)\n\n3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)'}], 'classes': [{'title': 'Power Doppler Imaging (PDI) : Benign', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'Power Doppler Imaging (PDI) : Malignant', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Power Doppler Imaging (PDI) : Not Characterized', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}]}]}, {'title': '3D SHI : Benign', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}]}]}, {'title': '3D SHI : Malignant', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': '3D SHI : Not Characterized', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}]}]}, {'title': 'Harmonic Imaging (HI) : Benign', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Harmonic Imaging (HI) : Malignant', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Harmonic Imaging (HI) : Not Characterized', 'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours', 'description': 'Characterization of benign and malignant breast cancer lesions is compared by each imaging method which evaluates vascular activity. Imaging methods to be compared are 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging (HI), fundamental grayscale ultrasound (US) or power Doppler imaging (PDI). Data will be analyzed qualitatively.', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Vascular Volume of Breast Lesions as Assessed by Subharmonic Imaging (SHI) Signal Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '3D HI and SHI of UCA', 'description': 'Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)\n\n3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)'}], 'classes': [{'title': 'Central Benign lesions', 'categories': [{'measurements': [{'value': '1.83', 'spread': '0.16', 'groupId': 'OG000'}]}]}, {'title': 'Peripheral benign lesions', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.09', 'groupId': 'OG000'}]}]}, {'title': 'Central malignant lesions', 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.33', 'groupId': 'OG000'}]}]}, {'title': 'peripheral malignant lesions', 'categories': [{'measurements': [{'value': '1.26', 'spread': '0.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 hours', 'description': 'Quantitative measures of the vascular volumes of breast lesions determined by SHI utilizing bifurcations and vessel length, and blood pool and parametric imaging', 'unitOfMeasure': 'dB', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'breast cancer lesions'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '3D HI and SHI of UCA', 'description': 'Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)\n\n3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '219'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '219'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '3D HI and SHI of UCA', 'description': 'Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)\n\n3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '175', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '219', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '204', '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': '14', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '97', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '108', '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': '219', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2011-07-13', 'size': 444182, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-07T14:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2011-12-08', 'resultsFirstSubmitDate': '2019-11-08', 'studyFirstSubmitQcDate': '2011-12-09', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-20', 'studyFirstPostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Breast Cancer Lesions Characterized as Malignant or Benign With 3D SHI, Harmonic Imaging (HI) or Power Doppler Imaging (PDI)', 'timeFrame': '2 hours', 'description': 'Characterization of benign and malignant breast cancer lesions is compared by each imaging method which evaluates vascular activity. Imaging methods to be compared are 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging (HI), fundamental grayscale ultrasound (US) or power Doppler imaging (PDI). Data will be analyzed qualitatively.'}], 'secondaryOutcomes': [{'measure': 'Change in Vascular Volume of Breast Lesions as Assessed by Subharmonic Imaging (SHI) Signal Intensity', 'timeFrame': '2 hours', 'description': 'Quantitative measures of the vascular volumes of breast lesions determined by SHI utilizing bifurcations and vessel length, and blood pool and parametric imaging'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breast abnormality', 'ultrasound imaging', 'ultrasound contrast agent', 'subharmonic imaging'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '17690324', 'type': 'BACKGROUND', 'citation': 'Forsberg F, Piccoli CW, Merton DA, Palazzo JJ, Hall AL. Breast lesions: imaging with contrast-enhanced subharmonic US--initial experience. Radiology. 2007 Sep;244(3):718-26. doi: 10.1148/radiol.2443061588. Epub 2007 Aug 9.'}]}, 'descriptionModule': {'briefSummary': 'This is a non-randomized trial of 450 women with a breast abnormality, who are scheduled for a breast biopsy of this abnormality. The study will be conducted at two clinical sites. The primary objective of this trial is:\n\nTo evaluate if quantitative 3D Subharmonic imaging (SHI) or pulse inversion harmonic imaging (HI) can improve the characterization of benign and malignant breast masses (independently or in combination with other imaging modes) compared to x-ray mammography, fundamental grayscale ultrasound (US) or power Doppler imaging (PDI).\n\nThe secondary aim of this trial is:\n\nTo compare quantitative (bifurcations \\& vessel length) and semi-quantitative (blood pool \\& parametric imaging) measures of the vascular morphology of breast lesions determined by pathology and by SHI.', 'detailedDescription': 'This is an open-label, non-randomized trial that will be conducted at two clinical sites (the Breast Imaging Centers at Thomas Jefferson University (TJU) Hospital and University of California, San Diego (UCSD) Hospital). All 450 subjects will receive at most two IV bolus injections of Definity (Lantheus Medical Imaging, Billerica, MA), will undergo an unenhanced (baseline) and Definity contrast-enhanced US imaging study for evaluation of a breast mass or breast abnormality without mass, and will be scheduled to undergo a clinically indicated biopsy of the breast lesion under investigation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be a female diagnosed by x-ray mammography (performed within 90 days prior to the study procedure) as having a solid breast mass or abnormal area without a mass.\n* Be scheduled for a biopsy (core / excisional / lumpectomy) of the mass or region of abnormality or for mastectomy within 30 days after this study procedure.\n* Be at least 18 years of age.\n* Be medically stable.\n* If a female of child-bearing potential, must have a negative pregnancy test.\n* Have signed Informed Consent to participate in the study.\n\nExclusion Criteria:\n\n* Males\n* Females who are pregnant or nursing.\n* Patients whose breast lesion is unequivocally a cyst by unenhanced US.\n* Patients currently on chemotherapy or with other primary cancers requiring systemic treatment.\n* Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:\n* Patients on life support or in a critical care unit.\n* Patients with unstable occlusive disease (eg, crescendo angina)\n* Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.\n* Patients with uncontrolled congestive heart failure (NYHA Class IV)\n* Patients with recent cerebral hemorrhage.\n* Patients with clinically significant and unstable renal and/or liver disease (eg, transplant recipients in rejection)\n* Patients who have undergone surgery within 24 hours prior to the study sonographic examination.\n* Patients with known hypersensitivity to perflutren\n* Patients who have received any contrast medium (X-ray, MRI, CT, of US) in the 24 hours prior to the research US exam\n* Patients with cardiac shunts.\n* Patients with congenital heart defects.\n* Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.\n* Patients with confirmed or suspected liver lesions.\n* Patients with respiratory distress syndrome.\n* Patients who have had excisional biopsy/lumpectomy of the current area of interest within the past 6 weeks.'}, 'identificationModule': {'nctId': 'NCT01490892', 'briefTitle': 'Quantitative Subharmonic Breast Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Quantitative Subharmonic Breast Imaging', 'orgStudyIdInfo': {'id': '11F.438'}, 'secondaryIdInfos': [{'id': 'R01CA140338', 'link': 'https://reporter.nih.gov/quickSearch/R01CA140338', 'type': 'NIH'}, {'id': 'JT 2179', 'type': 'OTHER', 'domain': 'JeffTrial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D HI and SHI of UCA', 'description': 'Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)', 'interventionNames': ['Drug: 3D HI and SHI of UCA']}], 'interventions': [{'name': '3D HI and SHI of UCA', 'type': 'DRUG', 'otherNames': ['Definity'], 'description': 'Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)', 'armGroupLabels': ['3D HI and SHI of UCA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University, Dept of Radiology', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Flemming Forsberg, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Lantheus Medical Imaging', 'class': 'INDUSTRY'}, {'name': 'University of California, San Diego', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}