Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 5:25 AM
Study NCT ID:
NCT01089894
Status:
UNKNOWN
Last Update Posted:
2010-03-19
First Post:
2010-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Application of 18F-3'-Fluoro-3'-Deoxy-L-thymidine (18F-FLT) Positron Emission Tomography (PET) in Lung Tumors
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': 'D006965', 'term': 'Hyperplasia'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-03-18', 'studyFirstSubmitDate': '2010-03-17', 'studyFirstSubmitQcDate': '2010-03-18', 'lastUpdatePostDateStruct': {'date': '2010-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['18F-FLT', 'PET', 'non-small cell lung cancer', 'cell proliferation', 'therapeutic response', "18F-3'-fluoro-3'-deoxy-L-thymidine (18F-FLT)"], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': "The ability of 18F-FDG PET for characterizing lung nodule remains a challenge, especially in Taiwan where tuberculosis is still prevalent.\n\n18F-3'-fluoro-3'-deoxy-L-thymidine (18F-FLT), a radiolabeled analog of thymidine, can be trapped within the cytosol after being monophosphorylated by thymidine kinase-1 (TK-1), a principle enzyme in the salvage pathway of DNA synthesis. It has been demonstrated in cell culture, animal models and clinical studies that the accumulation of 18F-FLT is closely associated with cellular proliferation. 18F-FLT PET may be more accurate than 18F-FDG PET in differentiating benign from malignant pulmonary lesions. In addition, the correlation between 18F-FLT uptake and cellular proliferation hints the usefulness of 18F-FLT PET for monitoring treatment response with cytostatic anticancer drugs.\n\nWe thus design this prospective 3-year project\n\n1. To evaluate the usefulness of 18F-FLT PET and 18F-FDG PET in differentiating benign from malignant pulmonary nodules in Taiwan where tuberculosis is still prevalent.\n2. To assess the usefulness of 18F-FLT PET in early prediction of therapeutic response of platinum-based chemotherapies or EGFR inhibitors for NSCLC patients.\n3. To correlate 18F-FLT uptake with EGFR mutation status, therapeutic response and survival for NSCLC patients.", 'detailedDescription': "Lung cancer has become a leading cause of cancer death in Taiwan. 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) using has been found to be effective in diagnosing, staging, and restaging primary non-small cell lung cancer (NSCLC). However, 18F-FDG is not tumor specific. It may also show increased uptake in benign tumors and tissue with inflammatory cells, such as macrophages and fibroblast. Therefore, the ability of 18F-FDG PET for characterizing lung nodule remains a challenge, especially in Taiwan where tuberculosis is still prevalent.\n\nRecently, 18F-3'-fluoro-3'-deoxy-L-thymidine (18F-FLT), a radiolabeled analog of thymidine, has been synthesized for imaging tumor cell proliferation in vivo. The tracer is trapped within the cytosol after being monophosphorylated by thymidine kinase-1 (TK-1), a principle enzyme in the salvage pathway of DNA synthesis. It has been demonstrated in cell culture, animal models and clinical studies that the accumulation of 18F-FLT is dependent on the presence of TK-1 and therefore is closely associated with cellular proliferation. Malignant lung lesions revealed significant 18F-FLT accumulation while benign lung tumors showed no 18F-FLT uptake. Therefore, 18F-FLT PET may be more accurate than 18F-FDG PET in differentiating benign from malignant pulmonary lesions. In addition, the correlation between 18F-FLT uptake and cellular proliferation hints the usefulness of 18F-FLT PET for monitoring treatment response with cytostatic anticancer drugs.\n\nIn the meantime, the cyclotron and hot lab facility in National Taiwan University Hospital (NTUH) has developed 18F-FLT successfully. After careful quality assurance and animal experiments, it is now ready to perform clinical studies on human beings.\n\nWe thus design this prospective 3-year project\n\n1. To evaluate the usefulness of 18F-FLT PET and 18F-FDG PET in differentiating benign from malignant pulmonary nodules in Taiwan where tuberculosis is still prevalent.\n2. To assess the usefulness of 18F-FLT PET in early prediction of therapeutic response of platinum-based chemotherapies or EGFR inhibitors for NSCLC patients.\n3. To correlate 18F-FLT uptake with EGFR mutation status, therapeutic response and survival for NSCLC patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '18F-FLT 1: 18F-FLT in differentiating benign from malignant pulmonary nodules\n\n18F-FLT 2: 18F-FLT in evaluating therapeutic response of platinum-based chemotherapy (The chemotherapeutic drugs used in the study are all approved by the Department of Health\n\n18F-FLT 3: 18F-FLT in evaluating therapeutic response of EGFR tyrosin kinase inhibitors (The target therapeutic drugs used in the study are all approved by the Department of Health, Taiwan.)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n18F-FLT 1:\n\n1. indeterminate pulmonary nodule(s)\n2. has been scheduled an 18F-FDG PET for characterization of their indeterminate pulmonary nodule(s)\n3. consent to perform an additional 18F-FLT PET\n4. will receive biopsy or surgery for the pulmonary nodule(s)\n\n18F-FLT 2:\n\n1. has pathological proved NSCLC\n2. is staged as inoperable advanced NSCLC\n3. has been scheduled to receive platinum-based chemotherapy\n4. consents to received 18F-FLT PET studies before, at the day before initiation of 2nd cycle of therapy or at 7 days after completion of therapy\n\n18F-FLT 3:\n\n1. has pathological proved NSCLC\n2. is staged as inoperable advanced NSCLC\n3. has been scheduled to receive EGFR tyrosine kinase inhibitor therapy\n4. consents to received 18F-FLT PET studies before, at the 2nd day or at the 7th day of therapy\n5. consents to undergo EGFR mutation analysis\n\nExclusion Criteria:\n\n1. Patients with other known malignancies\n2. Age under 18 years\n3. Hematological parameters: WBC \\< 3000/L or platelet \\< 75,000/L (WHO toxicity criteria of grade 1)\n4. Abnormal liver function: AST or ALT \\> 78U/L (WHO toxicity criteria of grade 1)\n5. Renal function: Creatinine \\> 2.0 mg/dl (WHO toxicity criteria of grade 1)'}, 'identificationModule': {'nctId': 'NCT01089894', 'briefTitle': "Clinical Application of 18F-3'-Fluoro-3'-Deoxy-L-thymidine (18F-FLT) Positron Emission Tomography (PET) in Lung Tumors", 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Clinical Application of 18F-FLT PET in Lung Tumors', 'orgStudyIdInfo': {'id': '200712071R'}}, 'armsInterventionsModule': {'armGroups': [{'label': '18F-FLT 1', 'description': '18F-FLT in differentiating benign from malignant pulmonary nodules'}, {'label': '18F-FLT 2', 'description': '18F-FLT in evaluating therapeutic response of platinum-based chemotherapy (The chemotherapeutic drugs used in the study are all approved by the Department of Health, Taiwan.)'}, {'label': '18F-FLT 3', 'description': '18F-FLT in evaluating therapeutic response of EGFR tyrosin kinase inhibitors (The target therapeutic drugs used in the study are all approved by the Department of Health, Taiwan.)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10043', 'city': 'Taipei', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ruoh-Fang Yen, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'rfyen@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '65581'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Ruoh-Fang Yen, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'rfyen@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '65581'}], 'overallOfficials': [{'name': 'Ruoh-Fang Yen, M.D PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Yen RF', 'oldOrganization': 'National Taiwan University Hospital'}}}}