Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
Study NCT ID:
NCT04289532
Status:
COMPLETED
Last Update Posted:
2020-03-06
First Post:
2020-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Integrin α6-targeted SPECT Imaging of Breast Cancer
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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-04', 'studyFirstSubmitDate': '2020-02-25', 'studyFirstSubmitQcDate': '2020-02-26', 'lastUpdatePostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Clearance', 'timeFrame': '1,3,5,10,15,30,60,120 minutes post-injection', 'description': 'The %ID (the radioactivity of the blood at each time period/the total injection activity) is calculated.'}, {'measure': 'Excretion', 'timeFrame': '0-24 hours post-injection', 'description': 'The %ID (the radioactivity of the urine at each time period/the total injection activity) is calculated.'}, {'measure': 'Biodistribution', 'timeFrame': '0.5,1,2,4,24 hours post-injection', 'description': 'Area under the activity-time curve from hour 0 to last measurable activity.'}, {'measure': 'SPECT/CT imaging', 'timeFrame': 'post-injection', 'description': 'Image brightness is observed。'}, {'measure': 'Distributed in organs', 'timeFrame': '0.5,1,2,4,24 hours post-injection', 'description': 'The %ID (the radioactivity of the main organs at each time period/the total injection activity) is calculated.'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': '1 week post-injection', 'description': 'Adverse events within 1 week after the injection and scanning were followed and assessed.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'integrin α6', 'SPECT'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'A novel radiotracer 99mTc-RWY targeting Integrin α6 was developed, and the pilot first-in-human study for SPECT imaging of breast cancer was performed in seven healthy volunteers and two breast cancer patients to assess the safety and potential clinical applications of 99mTc-RWY.', 'detailedDescription': 'Integrin α6 associates with the survival and migration of breast cancer cells, which emerges as a predictor of reduced overall survival and worse prognosis. In this study, we developed an integrin α6-targeted radiotracer 99mTc-RWY for SPECT imaging of breast cancer. The safety, biodistribution and radiation dosimetry were studied in seven healthy volunteers, and the clinical potential of 99mTc-RWY was examined in two breast cancer patients. A single dose of 11.1 MBq/kg 99mTc-RWY was injected intravenously. Visual and semiquantitative methods were used to assess the SPECT/CT images. The routine Hematoxylin-Eosin (HE) staining and immunohistochemistry (IHC) staining were subsequently carried out to confirm the Integrin α6 expression of tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Healthy volunteers.\n* Body mass index (BMI) at 19 to 25 \\[Body mass index = body weight (kg)/ height squared (m2)\\];\n* Clinical laboratory tests (heart, liver, kidney, blood) indicators are in the normal range or abnormalities without clinical significance;\n* Informed written consents were obtained from all 9 subjects before the procedure.\n* Patients in suspicion of breast cancer by mammography or ultrasonography, and being able to provide basic information.\n\nExclution Criteria:\n\n• The investigator judged that it is not suitable for clinical trials based on the overall situation of the volunteers and patients.'}, 'identificationModule': {'nctId': 'NCT04289532', 'briefTitle': 'Integrin α6-targeted SPECT Imaging of Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'First-in-human Pilot Study of an Integrin α6-targeted Radiotracer for SPECT Imaging of Breast Cancer', 'orgStudyIdInfo': {'id': '010006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '99mTc-RWY SPECT/CT', 'description': 'Volunteers and patients were injected intravenously with 11.1 MBq/kg of 99mTc-RWY in one dose and underwent SPECT/CT scan 30-60 min later.', 'interventionNames': ['Drug: 99mTc-RWY']}], 'interventions': [{'name': '99mTc-RWY', 'type': 'DRUG', 'otherNames': ['99mTc-labeled peptide targeting integrin α6'], 'description': '99mTc-RWY were injected into volunteers and patients before the SPECT/CT scans .', 'armGroupLabels': ['99mTc-RWY SPECT/CT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Health Science Center', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'collaborators': [{'name': 'China-Japan Union Hospital, Jilin University', 'class': 'OTHER'}, {'name': 'Sun Yat-sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Fan Wang', 'investigatorAffiliation': 'Beijing University Health Science Center'}}}}