Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-31 @ 6:20 PM
Study NCT ID:
NCT00188695
Status:
COMPLETED
Last Update Posted:
2022-10-07
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C097921', 'term': 'ferumoxtran-10'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-06', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved delineation of normal pelvic lymph nodes in patients with uterine, cervical, bladder and prostate cancers.', 'timeFrame': 'once at time of imaging'}, {'measure': 'Improved clinical target volume (CTV) definition for the purpose of adjuvant irradiation of pelvic lymph nodes using intensity modulated radiotherapy (IMRT).', 'timeFrame': 'once at time of imaging'}], 'secondaryOutcomes': [{'measure': 'Comparison of target lymph node delineation between nodal imaging with USPIO and volume expansion of vascular anatomy.', 'timeFrame': 'once at time of imaging'}, {'measure': 'Demonstration of the pattern and distribution of pelvic nodal metastases in patients with uterine, cervical, bladder and prostate cancers.', 'timeFrame': 'once at time of imaging'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Uterine Neoplasms', 'Cervix Neoplasms', 'Bladder Neoplasms', 'Prostatic Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether or not a new contrast agent called Combidex, a contrast agent formulated from ultra-small superparamagnetic iron oxide (USPIO) improves the ability of Magnetic Resonance Imaging (MRI) to see lymph nodes in the pelvis. It might also help doctors tell whether or not cancer has spread to these lymph nodes. It might allow radiotherapy to be delivered more accurately.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed endometrial, cervix, prostate (cT1-cT3) or bladder cancer\n* no distant metastases\n* informed consent\n\nExclusion Criteria:\n\n* confirmed prostate carcinoma and PSA less than or equal to 4 or greater than 100\n* radical surgery or prior cryosurgery for prostate carcinoma, previous RT, hormonal manipulation or chemotherapy\n* biopsy-proven lymph node involvement\n* endometrium or cervix carcinoma who have undergone recent pelvic surgery with the exclusion of D\\&C or biopsy\n* bladder carcinoma with recent pelvic surgery with the exclusion of TURBT\n* previous or concurrent cancers other than superficial basal or squamous cell skin carcinoma unless disease-free for at least 5 yrs\n* contraindication to MR imaging\n* hip prosthesis\n* major medical or psychiatric illness\n* patients with known allergy to dextran or iron-containing compounds\n* patients with cirrhosis or hemochromatosis\n* patients receiving another MR contrast within 2 hrs prior to the ferumoxtran-10'}, 'identificationModule': {'nctId': 'NCT00188695', 'briefTitle': 'Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Pilot Study of MR Imaging With Ultra-small Superparamagnetic Iron Oxide for Pelvic Lymph Node Target Definition', 'orgStudyIdInfo': {'id': '03-0838-C'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MRI contrast agent Combidex (ferumoxtran-10)', 'type': 'PROCEDURE', 'description': 'Combidex as an MR-lymph node contrast agent for the detection of small lymph nodes and lymph metastases.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Michael Milosevic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Princess Margaret Hospital, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Princess Margaret Hospital, Canada', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Michael Milosevic, Principal Investigator', 'oldOrganization': 'University Health Network'}}}}