Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT00040560
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2002-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of 111In-DAC as an Medical Imaging Agent for Lung Cancer and Brain Cancer Consistent With Metastatic Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'statusVerifiedDate': '2003-01', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2002-06-28', 'studyFirstSubmitQcDate': '2002-07-01', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-07-02', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Lung Cancer', 'Metastatic Brain Cancer'], 'conditions': ['Lung Neoplasms', 'Carcinoma, Non-Small-Cell Lung', 'Brain Neoplasms', 'Metastases, Neoplasm']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and imaging ability of 111In-DAC when used with planar and SPECT imaging for the detection of lung cancer and brain cancer consistent with metastatic lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients will be eligible for the study if they:\n\n* Are male or non-pregnant, non-lactating females 18 years of age or older (must agree to use an appropriate and effective method of birth control during the study and for 2 weeks after study)\n* Have an ECOG performance status of Zero or One\n* Are being evaluated for known or suspected non-small-cell lung cancer (NSCLC), or known brain lesions consistent with metastatic lung cancer\n* (For NSCLC patients)Have been previously scheduled for biopsy or surgical excision of the suspected NSCLC, or have a pathological diagnosis of lung cancer within 2 months of enrollment but have received no previous treatment\n* (For brain cancer patients) Have clinical signs and symptoms consistent with a primary NSCLC with histological or cytopathological confirmation. Patients cannot have received previous treatment with radiation to the brain.\n* Have signed an informed consent form\n\nExclusion Criteria\n\nPatients will not be eligible for this study if they:\n\n* Have a history or suspicion of significant allergic reaction or anaphylaxis to any of the 111In-DAC components\n* Have a clinically unstable medical condition or opportunistic infection, a life-threatening disease state, impaired renal or hepatic function or are immunosuppressed\n* Are taking or have taken part in any investigational study within 30 days of start of study\n* Have received an indium agent within 30 days of start of study\n* Are not able to remain immobile during scanning time\n* Have taken drugs that may damage the kidneys within 2 weeks of start of study\n* Have abnormal laboratory test results: hemoglobin\\<9.5 gms/dl, serum creatinine\\>1.5mg/100ml, alkaline phosphatase 2X the upper limit of normal\n* Have undergone an excisional and/or needle localization biopsy within 4 days prior to study drug administration\n* Have undergone a PET scan within 7 days prior to study drug administration\n* Have any active or previously treated second malignancy except carcinoma in situ of the uterine cervix or non-melanoma skin cancer'}, 'identificationModule': {'nctId': 'NCT00040560', 'briefTitle': 'Study of 111In-DAC as an Medical Imaging Agent for Lung Cancer and Brain Cancer Consistent With Metastatic Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Copharos'}, 'orgStudyIdInfo': {'id': 'CP102'}}, 'armsInterventionsModule': {'interventions': [{'name': '111In-DAC', 'type': 'DRUG'}, {'name': 'Diagnostic', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95661', 'city': 'Roseville', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Roseville Medical Center', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copharos', 'class': 'INDUSTRY'}}}}