Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-03-03 @ 6:05 PM
Study NCT ID:
NCT01778933
Status:
COMPLETED
Last Update Posted:
2018-07-03
First Post:
2013-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Imagery of Renal Nodules With Folate-fluorescein Conjugate(EC17)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-29', 'studyFirstSubmitDate': '2013-01-18', 'studyFirstSubmitQcDate': '2013-01-25', 'lastUpdatePostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The ability of EC17 and the imaging system to detect FRA positive tumors during surgery conducted 2-4 hours post EC-17 administration.', 'timeFrame': 'Within two to four hours of injection of the EC17'}], 'secondaryOutcomes': [{'measure': 'The number of participants that will have an adverse reaction to the EC17', 'timeFrame': 'Day 1 - Day 30'}]}, 'conditionsModule': {'keywords': ['Renal cell carcinoma', 'Renal nodules'], 'conditions': ['Renal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '26541080', 'type': 'RESULT', 'citation': 'Guzzo TJ, Jiang J, Keating J, DeJesus E, Judy R, Nie S, Low P, Lal P, Singhal S. Intraoperative Molecular Diagnostic Imaging Can Identify Renal Cell Carcinoma. J Urol. 2016 Mar;195(3):748-55. doi: 10.1016/j.juro.2015.09.093. Epub 2015 Nov 2.'}]}, 'descriptionModule': {'briefSummary': 'According to the National Cancer Institute, an estimated 64,770 men and women will be diagnosed with kidney cancer in 2012. Of this number, an estimated 13,570 will die of this disease. Surgery remains one of the best options for patients presenting with operable Stage II or III cancers, however the five year survival rate for these candidates remains at a dismal 63.7% for Stage II and 11% for Stage III. The high rates of recurrence suggest that surgeons are unable to completely detect and remove primary tumor nodules in a satisfactory manner as well as lingering metastases in sentinel lymph nodes. By ensuring a negative margin through imaging during surgery it would be possible for the investigators to improve the rates of recurrence free patients and thus overall survival.\n\nRenal cell malignancies are the ideal disease to investigate intra-operative imaging. 70% of kidney malignancies express folate receptor alpha (FRA). It is important to note that FRA is expressed only in the proximal tubules of the kidneys, activated macrophages, and in the choroidal plexus. Thus, the false positive detection rate is expected to be extremely low. A group well known to us in the Netherlands has completed a pilot study utilizing a folate-FITC conjugate in 12 patients with ovarian cancer. Another group of investigators in Mayo have subsequently performed this study on 20 more patients without any serious adverse events (personal communication). They report excellent sensitivity and specificity with this technique with only grade 1 side effects (allergic reaction). All side effects reversed when the injection was halted. Patients with a history of allergic reactions to insect bites should not participate (fluorescein is derived from the firefly insect, folate is an essential vitamin).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patients 18 years of age or older\n2. Patients presenting with a renal cell nodule or mass that are scheduled for open or laparoscopic resection based on clinical criteria\n3. Good operative candidate\n4. Subject capable of giving informed consent and participating in the process of consent.\n\nExclusion Criteria:\n\n1. Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) test within 72 hours of surgery\n2. Patients with a history of anaphylactic reactions to Folate-FITC or insects\n3. At-risk patient populations\n\n 1. People who would be easily lost to follow-up (ex: People who are homeless or alcohol dependent)\n 2. Children and neonates\n 3. Patients unable to participate in the consent process'}, 'identificationModule': {'nctId': 'NCT01778933', 'briefTitle': 'Intraoperative Imagery of Renal Nodules With Folate-fluorescein Conjugate(EC17)', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'A Pilot and Feasibility Study Of The Imaging Potential Of EC17 In Subjects Undergoing Surgery Presenting With Renal Nodules', 'orgStudyIdInfo': {'id': 'EC17 Renal Cell'}, 'secondaryIdInfos': [{'id': '816726', 'type': 'OTHER', 'domain': 'UPenn IRB Protocol #'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EC17 Injection Group', 'description': 'The group will receive a single dose of EC17, infused over 10 minutes, prior to surgery. Then, during surgery, the EC-17 will be imaged with a camera that the investigators have developed.', 'interventionNames': ['Drug: EC17']}], 'interventions': [{'name': 'EC17', 'type': 'DRUG', 'armGroupLabels': ['EC17 Injection Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Sunil Singhal, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine, Assistant Professor of Surgery, Director Thoracic Surgery Research Laboratory', 'investigatorFullName': 'Sunil Singhall', 'investigatorAffiliation': 'University of Pennsylvania'}}}}