Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:41 PM
Study NCT ID:
NCT03492151
Status:
RECRUITING
Last Update Posted:
2025-08-22
First Post:
2018-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010181', 'term': 'Pancreatic Cyst'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Pancreas cyst fluid from EUS-nCLE'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2018-04-02', 'studyFirstSubmitQcDate': '2018-04-02', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of PCL diagnosis', 'timeFrame': '48 months', 'description': 'Diagnostic accuracy of confocal laser endomicroscopy and/or cyst fluid molecular markers and/or composite clinical and imaging features for the diagnosis of mucinous PCLs, PCLs with malignant potential, specific PCL types, and mucinous PCLs with advanced neoplasia.'}, {'measure': 'Accuracy of risk-stratification of IPMNs', 'timeFrame': '48 months', 'description': 'Diagnostic accuracy of confocal laser endomicroscopy and/or composite clinical and imaging features for the risk stratification of IPMNs'}], 'secondaryOutcomes': [{'measure': 'Imaging quality', 'timeFrame': '48 months', 'description': 'Optimal quality of imaging obtained during in vivo confocal laser endomicroscopy of pancreatic cystic lesions'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Confocal laser endomicroscopy', 'pancreatic cancer', 'IPMN'], 'conditions': ['Pancreatic Cyst']}, 'referencesModule': {'references': [{'pmid': '33039474', 'type': 'DERIVED', 'citation': 'Firkins SA, Chen W, Krishna SG. Morphologic and Microscopic Characterization of an Unusual Pancreatic Cystic Lesion. Gastroenterology. 2021 May;160(6):e14-e16. doi: 10.1053/j.gastro.2020.09.046. Epub 2020 Oct 8. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The study schema is shown in Figure 4. (A) All patients referred to one of the participating academic centers for EUS evaluation of the PCL will be enrolled in the protocol if they satisfy inclusion criteria. Patient consent will be obtained during the clinic visit or prior to their EUS. EUS-guided nCLE imaging is first performed (B) followed by EUS-guided FNA and aspiration of cyst fluid. The cyst fluid is analyzed for CEA and cytology. As per institutional standard of care, the cyst fluid is also sent for molecular analysis. The results of the cyst fluid molecular analysis (B) will be utilized for the most likely diagnosis. Based on institutional multidisciplinary tumor board meetings, surgery is performed as indicated (C). Surgical histopathology serves as "gold standard" for diagnosis. It is anticipated that the majority of patients will undergo surgical resection after their EUS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects for this study will be identified from patients referred for diagnostic EUS-FNA of PCLs for a non-study indication by a physician responsible for their care (i.e., gastroenterologists, oncologists, general internists, and surgeons) either at the primary study center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient age 18 years or older\n* All patients referred for EUS-FNA of accessible PCL where surgery is contemplated\n* Minimum cyst size should be ≥ 2.0 cm as determined by prior cross-sectional imaging studies\n\nExclusion Criteria:\n\n* Unable to obtain informed consent\n* Unable to tolerate the procedure\n* Women with known pregnancy at time of procedure\n* Patient age less than 18 years\n* Bleeding diathesis\n* Known allergy to fluorescein\n* Prior pancreatic cancer\n* Prior pancreatic surgery'}, 'identificationModule': {'nctId': 'NCT03492151', 'acronym': 'CLIMB', 'briefTitle': 'Confocal Laser Endomicroscopy as an Imaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'Confocal Laser Endomicroscopy as an IMaging Biomarker for the Diagnosis of Pancreatic Cystic Lesions', 'orgStudyIdInfo': {'id': '2017C0192'}}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Veronica Oria', 'role': 'CONTACT', 'email': 'Oria.Veronica@mayo.edu'}, {'name': 'Rahul Pannala', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic Scottsdale Campus', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Samer El-Dika', 'role': 'CONTACT', 'email': 'Samereld@stanford.edu'}, {'name': 'Samer El-Dika', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Stanford Hospital', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chloe Bennett', 'role': 'CONTACT', 'email': 'chloe.bennett@yale.edu'}, {'name': 'Thiruvengadam Muniraj, MD, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yale School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '46805', 'city': 'Fort Wayne', 'state': 'Indiana', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Parkview Hospital Randallia', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kylie Ning', 'role': 'CONTACT', 'email': 'kning2@jhu.edu'}, {'name': 'Anne Marie Lennon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Roya Dastjerdi, MPH', 'role': 'CONTACT', 'email': 'rdastjer@bidmc.harvard.edu'}, {'name': 'Mandeep Sawhney, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '11530', 'city': 'Garden City', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maria Marotta-Kollarus', 'role': 'CONTACT', 'email': 'Maria.Kollarus@nyulangone.org'}, {'name': 'Jessica Widmer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tomas Gonda, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.72677, 'lon': -73.6343}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sharon Slomovich', 'role': 'CONTACT', 'email': 'Sharon.slomovich@snch.org'}, {'name': 'Frank Gress, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Megan Fry', 'role': 'CONTACT', 'email': 'Megan.Fry@osumc.edu', 'phone': '614-293-1056'}], 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chandra Kovvali', 'role': 'CONTACT', 'email': 'ckovvali@bcm.edu', 'phone': '713-798-2308'}, {'name': 'Mohamed Othman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Megan Fry', 'role': 'CONTACT', 'email': 'Megan.Fry@osumc.edu', 'phone': '614-293-1056'}, {'name': 'Diana Burke', 'role': 'CONTACT', 'email': 'Diana.Burke@osumc.edu'}], 'overallOfficials': [{'name': 'Somashekar Krishna, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'American College of Gastroenterology', 'class': 'OTHER'}, {'name': 'The National Pancreas Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Somashekar Krishna', 'investigatorAffiliation': 'Ohio State University'}}}}