Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-25 @ 7:11 PM
Study NCT ID:
NCT01780532
Status:
WITHDRAWN
Last Update Posted:
2017-01-30
First Post:
2011-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Photoacoustic Imaging (PAI) of Suspicious Breast Cancers - A Clinical Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Insufficient resources', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-27', 'studyFirstSubmitDate': '2011-11-14', 'studyFirstSubmitQcDate': '2013-01-30', 'lastUpdatePostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The lesion visibility on PAI, described using a five-level scale: 1. Not visible 2. Barely visible 3. Fair (or moderately visible) 4. Visible 5. Clearly visible.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Measures of hypoxia in the lesion', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'After locating the suspicious lesion/mass with standard of care mammography and/or ultrasound, a photoacoustic scan will be performed in the breast where the lesion is located. After the PA scan a biopsy will be performed, if clinically indicated (based on the mammogram and ultrasound only).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have a breast lesion/mass found at physical examination, mammography or ultrasound (US), that has not been surgically resected\n* Patients may have any of the following characteristics:\n\n * Taking hormones (e.g., contraceptives, hormone replacement therapy, post-cancer Tamoxifen)\n * Breast implants\n * Previous breast biopsy\n * Previous breast surgery\n * Previous breast cancer\n * High risk of breast cancer (e.g., breast cancer susceptibility gene (BRCA) mutations, other gynecologic cancer)\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients who have had primary surgical excision of the suspicious finding\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT01780532', 'briefTitle': 'Photoacoustic Imaging (PAI) of Suspicious Breast Cancers - A Clinical Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Pilot Photoacoustic Imaging (PAI) of Suspicious Breast Cancers - A Clinical Feasibility Study', 'orgStudyIdInfo': {'id': 'BRS0018'}, 'secondaryIdInfos': [{'id': 'SU-09022011-8372', 'type': 'OTHER', 'domain': 'Stanford University'}, {'id': '21623', 'type': 'OTHER', 'domain': 'Stanford IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Photo Acoustic Imaging', 'description': 'An exploratory, single armed, pilot study designed to evaluate the feasibility of Photo Acoustic Imaging (PAI) in a clinical setting.', 'interventionNames': ['Procedure: Photoacoustic Imaging (PAI)']}], 'interventions': [{'name': 'Photoacoustic Imaging (PAI)', 'type': 'PROCEDURE', 'otherNames': ['Hand held photoacoustic probe'], 'description': 'Standard of Care', 'armGroupLabels': ['Photo Acoustic Imaging']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sanjiv Gambhir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair, Dept. of Radiology', 'investigatorFullName': 'Sanjiv Sam Gambhir', 'investigatorAffiliation': 'Stanford University'}}}}