Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-03-05 @ 11:14 AM
Study NCT ID:
NCT02653612
Status:
WITHDRAWN
Last Update Posted:
2018-03-02
First Post:
2016-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Imaging of Pulmonary Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This study has been terminated, without having enrolled any participants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-28', 'studyFirstSubmitDate': '2016-01-08', 'studyFirstSubmitQcDate': '2016-01-08', 'lastUpdatePostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Margin assessment', 'timeFrame': 'At the time of surgery', 'description': 'Percentage of surgeries which detect tumor cells at the surgical margin'}, {'measure': 'Lymph node assessment', 'timeFrame': '4 hours', 'description': 'Number of residual tumor cells in the lymph nodes detected via intraoperative imaging of a FR-targeted fluorescent contrast agent'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgery', 'folate receptor'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The goal is to improve surgery by preventing tumor cells from being left behind at the time of surgery. This includes finding residual tumor cells in the wound after surgery.', 'detailedDescription': 'The goal is to improve the intraoperative identification of tumor cells at positive margins and regional metastases that may be missed by a surgeon during a pulmonary resection. Improved identification of tumor cells will result in superior disease clearance and more accurate clinical staging. The investigators hypothesize that targeted fluorescent imaging during surgery will improve identification of positive margins and metastases. Since folate receptor alpha (FR ) is expressed on 55% of resectable lung cancer, the investigators will utilize a fluorescent probe that targets these tumors. As real-time imaging provides more information to the surgeon, more personalized and directed operations can be conducted. This work will allow for more preservation of normal tissue, decreased morbidity, decreased surgical time, increased surgical confidence, improved cancer detection, decreased unnecessary surgery and ultimately improved tumor free survival. This technology should transform clinical surgery from an art that depends fully on the human factor to a procedure that has precision and fail safes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* lung cancer\n* surgical candidate\n* operable\n* resectable\n\nExclusion Criteria:\n\n\\- no allergies to contrast dyes'}, 'identificationModule': {'nctId': 'NCT02653612', 'briefTitle': 'Intraoperative Imaging of Pulmonary Adenocarcinoma', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Intraoperative Imaging of Pulmonary Adenocarcinoma', 'orgStudyIdInfo': {'id': 'CLNB-009-14F'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm', 'description': 'This cohort will receive the contrast agent', 'interventionNames': ['Drug: EC17 imaging contrast agent']}], 'interventions': [{'name': 'EC17 imaging contrast agent', 'type': 'DRUG', 'description': 'This is an imaging agent to locate lung adenocarcinoma cancer cells during surgery', 'armGroupLabels': ['Experimental Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Colleen Gaughan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}