Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-04-18 @ 10:01 PM
Study NCT ID:
NCT02285192
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-09
First Post:
2014-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}], 'ancestors': [{'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2014-11-04', 'studyFirstSubmitQcDate': '2014-11-04', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnostic accuracy of Positron Lymphography', 'timeFrame': '2 years', 'description': 'Accuracy of Positron Lymphography will be defined in terms of sensitivity and will consist of pathology review of labelled, excised specimens compared with lymph node imaging data acquired preoperatively.'}], 'secondaryOutcomes': [{'measure': 'to evaluate several standard uptake value (SUV) (18F-FDG avidity)', 'timeFrame': '2 years', 'description': 'will assess the ability of SUV to predict malignant disease. The continuous variable of SUV assigned to a given lymph node during Positron Lymphography will be compared with the pathologic assessment (benign vs malignant) of each labelled lymph node. The SUV assigned to a given lymph node is done using the the imaging software and not up to the discretion of the radiologist.'}]}, 'conditionsModule': {'keywords': ['18F-FDG Injection', 'Positron Lymphography', 'Lymphatic Mapping', 'sentinel lymph nodes', 'PET/CT', '14-222'], 'conditions': ['Cervical Cancer', 'Endometrial Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if a radioactive substance called 18F-Fluorodeoxyglucose (18F- FDG), injected into the cervix during a PET/CT scan done before surgery can show us more clearly which lymph nodes in the pelvis (the area near your uterus and cervix) contain cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The study population will include women with stage IB1 cervical cancer (any histologic subtype) deemed eligible for surgery, and women with a clinical stage I high-grade endometrial cancer planning to undergo surgical staging. High grade is defined by the following:\n\n * Uterine serous carcinoma\n * Clear cell endometrial carcinoma\n * Grade 3 endometrioid carcinoma\n * Endometrial carcinosarcoma\n * Clinical stage I grade 1-2 endometrial cancer also eligible with deep myoinvasion ≥ 50% shown on preop MRI and/or elevated preop CA-125 \\> 35 U/ml.\n* Age ≥18 years\n* Hemoglobin ≥10 g/dL\n* Plasma albumin ≥3 g/dL\n* GOG performance status ≤2\n* Plasma glucose ≤200 mg/dL\n* Plasma creatinine ≤1.6\n* Well-controlled hypertension\n* Medical clearance for surgery and considered an appropriate surgical candidate\n* Negative serum pregnancy test, if of child-bearing potential\n* If, based on surgeon's assessment, the patient is recommended to undergo surgical staging for histologically confirmed endometrial cancer or if IB1 cervical cancer is deemed eligible for surgical treatment of disease\n* Participation in other research protocols does not exclude a patient from participation in this study\n\nExclusion Criteria:\n\n* Hemoglobin \\<10 g/dL\n* Plasma albumin \\<3 g/dL\n* GOG performance status \\>2\n* Plasma glucose \\>200 mg/dL\n* Renal insufficiency with plasma creatinine \\>1.6\n* Uncontrolled hypertension\n* Patient does not meet medical clearance for surgery and is not considered an appropriate surgical candidate\n* Pregnancy\n\nFor Stage 2:\n\n* Patient who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers of non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc.\n* Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI"}, 'identificationModule': {'nctId': 'NCT02285192', 'briefTitle': 'Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Positron Lymphography Via Intracervical 18F-FDG Injection for Pre-surgical Lymphatic Mapping in Stage IB1 Cervical Cancer and High-grade Endometrial Cancer', 'orgStudyIdInfo': {'id': '14-222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intracervical 18F-FDG injection during a dynamic PET/CT', 'description': 'The first 20 eligible patients will be consented to undergo intracervical 18F-FDG injection during a dynamic PET/CT scan. Study enrollment will occur in the clinic during the visit in which they are consented for surgery. Recruited patients will undergo 18F-FDG-guided PET imaging on the day of their scheduled staging surgery. The experimental PET/CT is anticipated to take 2 hours. The second stage of accrual will replace PET/CT with PET/MRI imaging. In every other aspect, patients will receive standard peri- and postoperative care.', 'interventionNames': ['Radiation: 18F-Fluorodeoxyglucose (18F-FDG)', 'Device: PET/CT imaging', 'Device: PET/MRI imaging']}], 'interventions': [{'name': '18F-Fluorodeoxyglucose (18F-FDG)', 'type': 'RADIATION', 'armGroupLabels': ['intracervical 18F-FDG injection during a dynamic PET/CT']}, {'name': 'PET/CT imaging', 'type': 'DEVICE', 'armGroupLabels': ['intracervical 18F-FDG injection during a dynamic PET/CT']}, {'name': 'PET/MRI imaging', 'type': 'DEVICE', 'armGroupLabels': ['intracervical 18F-FDG injection during a dynamic PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Basking Ridge (Consent only)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Monmouth (Consent only)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Bergen (Consent only)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Commack (Consent only)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Westchester (Consent only)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Uniondale', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Nassau (Consent only)', 'geoPoint': {'lat': 40.70038, 'lon': -73.59291}}], 'overallOfficials': [{'name': 'Jennifer Mueller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}