Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-30 @ 6:00 AM
Study NCT ID:
NCT07045103
Status:
RECRUITING
Last Update Posted:
2025-07-01
First Post:
2025-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2025-06-20', 'studyFirstSubmitQcDate': '2025-06-20', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peripheral TBBx and CBx Co-primary Endpoints', 'timeFrame': 'From enrollment to the End of the Procedure.', 'description': 'Detection of lung cancer in peripheral TBBx and CBx biopsies by NIO image analysis module with non-inferior performance compared to rapid on-site evaluation touch imprint cytology (ROSE-TIC)'}, {'measure': 'Peripheral Lung Transbronchial Fine Needle Aspiration Endpoint', 'timeFrame': 'From enrollment to the End of the Procedure.', 'description': 'Detection of lung cancer in peripheral lung transbronchial needle aspiration by NIO image analysis module with non-inferior performance compared to rapid on-site evaluation (ROSE).'}, {'measure': 'Lymph Node Endobronchial Ultrasound Transbronchial Fine Needle Aspiration Endpoint', 'timeFrame': 'From enrollment to the End of the Procedure.', 'description': 'Determine area-under-the-curve (AUC) of the receiver-operating-characteristic (ROC) of NIO image analysis module for detection of cancer at a lymph-node location.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Biopsy']}, 'descriptionModule': {'briefSummary': 'The ON-SITE study represents a prospective, observational study focused on the training/tuning and pivotal validation of deep learning algorithms that detect cell/tissue morphology suspicious for cancer in biopsies of peripheral lung nodules/masses and mediastinal/hilar lymph nodes imaged with the NIO Laser Imaging System in the procedure room without requiring traditional sample processing.\n\nThe study includes four arms based on biopsy location and biopsy modality/tool:\n\n1. Transbronchial forceps biopsy of peripheral lung nodules/masses (peripheral-TBBx)\n2. Transbronchial needle aspiration biopsy of peripheral lung nodules/masses (peripheral TBNA)\n3. Transbronchial needle aspiration biopsy of mediastinal/hilar lymph nodes (EBUS-TBNA)\n4. Transbronchial cryo biopsy of peripheral lung nodules/masses (peripheral-CBx)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are scheduled for routinely indicated staging of the mediastinum (EBUS-TBNA) and planned peripheral lung biopsy procedure (peripheral TBBx/TBNA) with an intermediate to high pretest probability of lung cancer based on clinician suspicion.\n\nPatients who meet criteria will be enrolled consecutively from 5 different Hospitals including MD Anderson Cancer Center, University of North Carolina Medical Center, Corewell Health, Montefiore Medical Center, Memorial Sloan Kettering Cancer Center, University of San Diego, Mayo Clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patient or legal guardian is willing and able to understand, sign and date the Ethics committee approved study specific Informed Consent Form.\n2. The patient is 22 years of age or older.\n3. The patient is scheduled for routinely indicated staging of the mediastinum (EBUS-TBNA) and planned peripheral lung biopsy procedure (peripheral TBBx/TBNA) with an intermediate to high pretest probability of lung cancer based on clinician suspicion.\n4. The patient can tolerate the clinical procedure as indicated.\n\nExclusion Criteria:\n\n1. Patient is a prisoner.\n2. The participant, in the judgment of the Investigator, may be inappropriate for the intended study procedures'}, 'identificationModule': {'nctId': 'NCT07045103', 'acronym': 'ON-SITE', 'briefTitle': 'A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Invenio Imaging Inc.'}, 'officialTitle': 'A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection', 'orgStudyIdInfo': {'id': 'INV-01-2022'}, 'secondaryIdInfos': [{'id': '1R44CA281581-01', 'link': 'https://reporter.nih.gov/quickSearch/1R44CA281581-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'ON-SITE Patients', 'description': 'Participants must fulfill all of the following criteria in order to be eligible for the study:\n\n1. The patient or legal guardian is willing and able to understand, sign and date the Ethics committee-approved study specific Informed Consent Form.\n2. The patient is 22 years of age or older.\n3. The patient is scheduled for routinely indicated staging of the mediastinum (EBUS-TBNA) and planned peripheral lung biopsy procedure (peripheral-TBBx/TBNA) with an intermediate to high pretest probability of lung cancer based on clinician suspicion.\n4. The patient can tolerate the clinical procedure as indicated.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'George Z Cheng, MD', 'role': 'CONTACT', 'email': 'gcheng@ucsd.edu', 'phone': '619-543-5840'}, {'name': 'George Z Cheng, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UC San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bryan Husta, MD', 'role': 'CONTACT', 'email': 'Husta.Bryan@mayo.edu', 'phone': '(904) 953-2861'}, {'name': 'Bryan Husta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gustavo Cumbo-Nachelli, MD', 'role': 'CONTACT', 'email': 'Gustavo.CumboNacheli@corewellhealth.org', 'phone': '616-821-8890'}, {'name': 'Gustavo Cumbo-Nachelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Corewell Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'SUSPENDED', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Da Costa, MD', 'role': 'CONTACT', 'email': 'daniel.dacosta@nyulangone.org', 'phone': '718-920-6441'}, {'name': 'Daniel Da Costa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jason Akulian, MD', 'role': 'CONTACT', 'email': 'akulian@email.unc.edu', 'phone': '860-770-4835'}, {'name': 'Jason Akulian, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UNC Medical Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Invenio Imaging Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'The University of Texas MD Anderson Cancer Center', 'class': 'UNKNOWN'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}, {'name': 'University of California, San Diego', 'class': 'OTHER'}, {'name': 'Montefiore Medical Center-Moses-Weiler', 'class': 'UNKNOWN'}, {'name': 'Corewell Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}