Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:33 PM
Study NCT ID:
NCT07318402
Status:
RECRUITING
Last Update Posted:
2026-01-26
First Post:
2025-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Operator Radiation Exposure During Image-Guided Robotic-Assisted Bronchoscopy: A Multicenter Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-23', 'studyFirstSubmitDate': '2025-12-23', 'studyFirstSubmitQcDate': '2025-12-23', 'lastUpdatePostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total operator radiation exposure dose', 'timeFrame': '1 year', 'description': 'as captured by a radiation dosimetry badge over 50 consecutive procedures. All study procedures in which image-guided RAB was performed for the sampling of a single parenchymal lung lesion will be evaluable for the primary endpoint.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Operator Radiation Exposure']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, single-arm, prospective, observational study designed to evaluate bronchoscopist radiation exposure during standard-of-care image-guided robotic-assisted bronchoscopy (RAB) for sampling of a single pulmonary parenchymal lesion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Operator performing standard of care image-guided robotic-assisted bronchoscopy for the sampling of a single pulmonary parenchymal lesion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Operator performing image-guided RAB on adult patients (age ≥18 years old)\n* A single participating operator per study site\n* Image-guided RAB procedure is planned for standard of care diagnostic sampling of a single parenchymal lung lesion at participating sites\n\nExclusion Criteria:\n\n* Operator refusal to participate\n* Image-guided RAB procedure performed on:\n\n * Patients age \\<18 years old\n * Pregnant women\n * Patients undergoing standard of care robotic assisted bronchoscopy with plan to sample \\>1 pulmonary parenchymal lesion\n * Patients undergoing standard of care robotic assisted bronchoscopy for lesion localization (injection of dye/marker or fiducial marker deployment)\n * Patients undergoing standard of care robotic assisted bronchoscopy for a therapeutic intervention'}, 'identificationModule': {'nctId': 'NCT07318402', 'briefTitle': 'Operator Radiation Exposure During Image-Guided Robotic-Assisted Bronchoscopy: A Multicenter Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Operator Radiation Exposure During Image-Guided Robotic-Assisted Bronchoscopy: A Multicenter Prospective Cohort Study', 'orgStudyIdInfo': {'id': '25-350'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Operator Radiation', 'description': 'During Image-Guided Robotic-Assisted Bronchoscopy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Or Kalchiem-Dekel, MD', 'role': 'CONTACT', 'phone': '212-639-5061'}], 'facility': 'Memorial Sloan Kettering Cancer Center (All Protocol Activites)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Or Kalchiem-Dekel, MD', 'role': 'CONTACT', 'email': 'kalchieo@mskcc.org', 'phone': '212-639-5061'}, {'name': 'Catherine Oberg', 'role': 'CONTACT', 'phone': '212-639-2773'}], 'overallOfficials': [{'name': 'Or Kalchiem-Dekel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}