Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT05554133
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2022-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Precision Optical Guidance for Oral Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011370', 'term': 'Proflavine'}], 'ancestors': [{'id': 'D000609', 'term': 'Aminoacridines'}, {'id': 'D000166', 'term': 'Acridines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2022-09-20', 'studyFirstSubmitQcDate': '2022-09-21', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To establish a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology', 'timeFrame': 'Through study completion an average of 1 year.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Oral Lesions']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To learn if a new type of imaging device called the Active Biopsy Guidance System can help doctors to decide when and where to perform invasive biopsies of mouth lesions.', 'detailedDescription': 'Primary objective:\n\n-To evaluate and optimize the technical performance characteristics of an Active Biopsy Guidance System.\n\nSecondary objective:\n\n-To provide a preliminary estimate of the sensitivity and specificity of the Active Biopsy Guidance System with respect to histopathology. Optical imaging; optical projection of light onto tissue; optical contrast agent (proflavine).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult subjects with clinically evident oral lesions such as leukoplakia or erythroplakia, oral potentially malignant disorders (OPMD) such as lichen planus and graft vs. host disease, pathologic diagnosis of dysplasia, squamous cell carcinoma, or a history of resected oral cancer, are eligible to participate. Patients with previous treatment including surgery, radiation, chemotherapy or other therapies are also eligible.\n2. Ability to understand and willingness to sign a written Informed Consent Document (ICD).\n\nExclusion Criteria:\n\n1. Known allergy to proflavine or acriflavine.\n2. Age less than 18 years.\n3. Pregnant or nursing females.\n4. Adults unable to consent\n5. Prisoners and other vulnerable populations'}, 'identificationModule': {'nctId': 'NCT05554133', 'briefTitle': 'Precision Optical Guidance for Oral Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Precision Optical Guidance for Oral Biopsy Based on Next-Generation Hallmarks of Cancer (1R01DE029590-01): A Clinical Study to Evaluate and Optimize the Technical Performance Characteristics of an Active Biopsy Guidance System', 'orgStudyIdInfo': {'id': '2020-1115'}, 'secondaryIdInfos': [{'id': 'NCI-2022-07929', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Trials Registry'}, {'id': 'R01DE029590-01', 'link': 'https://reporter.nih.gov/quickSearch/R01DE029590-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The Active Biopsy Guidance System', 'description': 'This imaging scanning device is made up of 2 parts: the optical mapping scope and the high-resolution microendoscope (HRME):', 'interventionNames': ['Device: High Resolution Microendoscope (HRME)', 'Device: Optical Mapping Scope', 'Drug: Proflavine hemisulfate']}], 'interventions': [{'name': 'High Resolution Microendoscope (HRME)', 'type': 'DEVICE', 'description': 'The High Resolution Microendoscope (HRME) take pictures of a very small area of the lining of the mouth, about the size of a pencil tip, but at high magnification.', 'armGroupLabels': ['The Active Biopsy Guidance System']}, {'name': 'Optical Mapping Scope', 'type': 'DEVICE', 'description': 'The optical mapping scope displays a wide area of the lining of the mouth (about the size of the top of a soda can) by shining different colors of light into the mouth and taking pictures.', 'armGroupLabels': ['The Active Biopsy Guidance System']}, {'name': 'Proflavine hemisulfate', 'type': 'DRUG', 'description': 'A coloring substance (a fluorescent dye which glows green in the dark), called proflavine hemisulfate, will be painted on areas of the mouth with a cotton tip applicator to help improve the pictures', 'armGroupLabels': ['The Active Biopsy Guidance System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ann Gillenwater, MD', 'role': 'CONTACT', 'email': 'agillenw@mdanderson.org', 'phone': '713-792-8841'}, {'name': 'Ann Gillenwater, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Ann Gillenwater, MD', 'role': 'CONTACT', 'email': 'agillenw@mdanderson.org', 'phone': '(713) 792-8841'}], 'overallOfficials': [{'name': 'Ann Gillenwater, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MD Anderson Caner Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Dental and Craniofacial Research (NIDCR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}