Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-02-20 @ 9:56 PM
Study NCT ID:
NCT03321461
Status:
UNKNOWN
Last Update Posted:
2021-06-30
First Post:
2017-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TMTP1-ICG Mapping in Colposcopy-directed Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-26', 'studyFirstSubmitDate': '2017-10-23', 'studyFirstSubmitQcDate': '2017-10-23', 'lastUpdatePostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity', 'timeFrame': '1 day', 'description': 'Sensitivity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG'}], 'secondaryOutcomes': [{'measure': 'Specificity', 'timeFrame': '7 days', 'description': 'Specificity of fluorescent detection of TMTP1-ICG compared to the sensitivity of ICG'}, {'measure': 'Incidence of adverse events', 'timeFrame': '7 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Intraepithelial Neoplasia']}, 'descriptionModule': {'briefSummary': 'Investigators aimed to determine the validity of the novel tumor targeted fluorescent TMTP1-ICG to increased accuracy of colposcopy-directed biopsy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspicious of cervical disease required a colposcopy-directed biopsy.\n* Subjects must sign an informed consent indicating awareness of the investigational nature of this study.\n\nExclusion Criteria:\n\n* Breast-feeding or pregnant.\n* Ongoing participation in another clinical trial with an investigational drug with 3 months.\n* Own allergy towards ICG and/or alcohol.\n* Diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases.\n* Patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency.'}, 'identificationModule': {'nctId': 'NCT03321461', 'briefTitle': 'TMTP1-ICG Mapping in Colposcopy-directed Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Novel Tumor Targeted Fluorescent TMTP1-ICG Mapping in Colposcopy-directed Biopsy', 'orgStudyIdInfo': {'id': 'TMTP1-ICG-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TMTP1', 'description': 'The TMTP1-ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. Then TMTP1-ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed.', 'interventionNames': ['Drug: TMTP1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ICG', 'description': 'The ICG (WuXi AppTec, Shanghai, China) powder was diluted in 20 ml of aqueous sterile water to a concentration of 1.0 mg/mL. ICG spray was applied thoroughly to the ectocervix for 30 minutes. After cleaned by NS, fluorescent detected sites will be removed.', 'interventionNames': ['Drug: ICG']}], 'interventions': [{'name': 'TMTP1', 'type': 'DRUG', 'description': 'Fluorescent sites will be removed', 'armGroupLabels': ['TMTP1']}, {'name': 'ICG', 'type': 'DRUG', 'description': 'Fluorescent sites will be removed', 'armGroupLabels': ['ICG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital, Tongji Medical Colledge, HUST', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Ding Ma', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}