Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT04016818
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-24
First Post:
2019-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution
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': 'D019788', 'term': 'Fluorodeoxyglucose F18'}], 'ancestors': [{'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2019-07-02', 'studyFirstSubmitQcDate': '2019-07-10', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image quality with the breast-dedicated PET camera', 'timeFrame': '1 day', 'description': 'Feasibility of the pilot breast-dedicated PET camera will be assessed on the basis of whether acceptable images are obtained. Images will be assessed and graded as 1 of 3 quality ratings: excellent, good, and poor. The outcome will be reported as the number of images that are excellent, good, and poor, a number without dispersion.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a research study of a novel, "breast-dedicated" positron emission tomography (PET) camera with 1 millimeter spatial resolution. The main goal of the study is for the personnel to understand practical and logistical issues with using the camera in the clinic', 'detailedDescription': 'Primary Objective To obtain initial experience using the novel, breast-dedicated PET camera design in the breast imaging clinic.\n\nSecondary Objectives To understand, given the 10-fold higher sensitivity of this novel camera, how low we can go with administered tracer dose, and, given the \\>100-fold better volumetric spatial resolution, understand the achievable image quality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy-confirmed breast cancer measuring ≥ 5 mm on mammogram or ultrasound.\n* Prior diagnostic imaging test(s) with another modality such as MRI, CT, or x-ray mammography (or other applicable imaging modalities) within 60 days prior to the study date.\n* Documented written informed consent document.\n\nExclusion Criteria:\n\n* 1\\. Additional condition, or extenuating circumstance that, in the opinion of the investigator, may interfere with study compliance.\n* Known allergies to FDG\n* Pregnant or nursing.'}, 'identificationModule': {'nctId': 'NCT04016818', 'briefTitle': 'Pilot Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Pilot Study of a Breast-Dedicated PET Camera With 1 Millimeter Spatial Resolution', 'orgStudyIdInfo': {'id': 'IRB-50877'}, 'secondaryIdInfos': [{'id': 'BRS0102', 'type': 'OTHER', 'domain': 'OnCore'}, {'id': 'IRB-50877', 'type': 'OTHER', 'domain': 'Stanford IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18-F FDG Study using Breast-Dedicated PET Camera', 'description': 'Breast-Dedicated PET Camera will be used with standard PET 18-F FDG tracer dose', 'interventionNames': ['Drug: 18F-FDG', 'Device: Breast-dedicated PET camera']}], 'interventions': [{'name': '18F-FDG', 'type': 'DRUG', 'otherNames': ['18F-fluorodeoxiglucose', '18F-FDG radiotracer'], 'description': 'Participant will be injected IV (intravenously) with 10 ± 2 mCi of 18F-FDG.', 'armGroupLabels': ['18-F FDG Study using Breast-Dedicated PET Camera']}, {'name': 'Breast-dedicated PET camera', 'type': 'DEVICE', 'description': 'Breast-dedicated PET camera designed by Stanford satellite radiochemistry facility', 'armGroupLabels': ['18-F FDG Study using Breast-Dedicated PET Camera']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Risa Jiron', 'role': 'CONTACT', 'email': 'rjiron@stanford.edu', 'phone': '650-736-1598'}], 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'centralContacts': [{'name': 'Risa Jiron', 'role': 'CONTACT', 'email': 'rjiron@stanford.edu', 'phone': '650-736-1598'}], 'overallOfficials': [{'name': 'Wendy B DeMartini', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}