Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-01-10 @ 1:27 PM
Study NCT ID:
NCT02995902
Status:
COMPLETED
Last Update Posted:
2022-05-09
First Post:
2016-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FLT-PET/DW-MRI for Detection of Brain Metastases and Early Therapy Evaluation in Patients With Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-03', 'studyFirstSubmitDate': '2016-12-09', 'studyFirstSubmitQcDate': '2016-12-16', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '1 year'}, {'measure': 'Disease free survival', 'timeFrame': '1 year'}]}, 'conditionsModule': {'conditions': ['Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '34191195', 'type': 'RESULT', 'citation': 'Christensen TN, Langer SW, Villumsen KE, Johannesen HH, Lofgren J, Keller SH, Hansen AE, Kjaer A, Fischer BM. 18F-fluorothymidine (FLT)-PET and diffusion-weighted MRI for early response evaluation in patients with small cell lung cancer: a pilot study. Eur J Hybrid Imaging. 2020 Jan 27;4(1):2. doi: 10.1186/s41824-019-0071-5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the value of FLT-PET early after initiated chemotherapy in patients with small cell lung cancer, and to determine whether MRI of the brain should be performed routinely in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* biopsy proven small cell lung cancer\n* referred for standard chemotherapy\n* oral and written informed consent\n\nExclusion Criteria:\n\n* metal or electronical devices in the body not compatible with MRI of brain or thorax\n* pregnancy or lactation\n* communication difficulties'}, 'identificationModule': {'nctId': 'NCT02995902', 'acronym': 'SIBES II', 'briefTitle': 'FLT-PET/DW-MRI for Detection of Brain Metastases and Early Therapy Evaluation in Patients With Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'FLT-PET/DW-MRI for Detection of Brain Metastases and Early Therapy Evaluation in Patients With Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '307_14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FLT-PET/MRI', 'interventionNames': ['Device: FLT-PET', 'Device: MRI']}], 'interventions': [{'name': 'FLT-PET', 'type': 'DEVICE', 'armGroupLabels': ['FLT-PET/MRI']}, {'name': 'MRI', 'type': 'DEVICE', 'armGroupLabels': ['FLT-PET/MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Andreas Kjær, MD phD MDSci', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept of Clinical Physiology, Nuclear medicine and PET, Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, research fellow', 'investigatorFullName': 'Tine Nøhr Christensen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}