Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-30 @ 2:50 PM
Study NCT ID:
NCT00721903
Status:
COMPLETED
Last Update Posted:
2016-05-05
First Post:
2008-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Three Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-03', 'studyFirstSubmitDate': '2008-07-23', 'studyFirstSubmitQcDate': '2008-07-23', 'lastUpdatePostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images.', 'timeFrame': '2002-2014', 'description': 'Self explanatory.'}], 'secondaryOutcomes': [{'measure': 'Spatially register pre, intra and post treatment ultrasound image volumes of treated tumor.', 'timeFrame': '2002-2014', 'description': 'Visually measure separation between two corresponding points in two ultrasound image volumes after registration to verify registration accuracy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans.', 'detailedDescription': 'To evaluate the proportions of correct diagnosis of response to breast Cancer therapies for localized breast cancer by ultrasound. To develop a model based on patient characteristics, physical exam, and radiologic studies which will predict the possibility that a patient has had a complete pathological response to chemotherapy neoadjuvant therapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed breast cancer prior to receiving breast cancer therapy.\n* Diagnosis of breast cancer must be confirmed by fine needle aspiration or core biopsy.\n\nExclusion Criteria:\n\n* Poorly controlled diabetes.\n* Contralateral mastectomy prior to neoadjuvant chemotherapy.\n* Not a surgical candidate.\n* No previous axillary lymph node dissection.'}, 'identificationModule': {'nctId': 'NCT00721903', 'briefTitle': 'Three Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': '3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies', 'orgStudyIdInfo': {'id': '2001-0124'}, 'secondaryIdInfos': [{'id': 'UMCC 0005', 'type': 'OTHER', 'domain': 'Univ. of Michigan Comprehensive Cancer Center'}, {'id': 'P01CA087634', 'link': 'https://reporter.nih.gov/quickSearch/P01CA087634', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Subjects', 'description': 'Ultrasound scan', 'interventionNames': ['Procedure: Ultrasound Scan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cancer', 'description': '120 women diagnosed by biopsy to have breast cancer will have an ultrasound scan', 'interventionNames': ['Procedure: Mammography and Ultrasound']}], 'interventions': [{'name': 'Ultrasound Scan', 'type': 'PROCEDURE', 'description': '10 female volunteers with normal breast who will be studied to refine imaging techniques and for comparison with patients. To the degree possible, the volunteer group will be age-matched to patients with symptoms, initially 30 to 70 years of age.', 'armGroupLabels': ['Healthy Subjects']}, {'name': 'Mammography and Ultrasound', 'type': 'PROCEDURE', 'description': 'To determine how well from ultrasound scans, changes in malignant masses can be measured, and to whether the use of a dye visible by ultrasound will be useful in evaluating different therapies for breast cancer.', 'armGroupLabels': ['Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Paul L. Carson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Paul Carson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Paul L. Carson Ph.D', 'investigatorAffiliation': 'University of Michigan'}}}}