Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-03-01 @ 6:00 AM
Study NCT ID:
NCT03053804
Status:
UNKNOWN
Last Update Posted:
2017-02-15
First Post:
2016-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Application of MR-PET in Non-small Cell Lung Cancer: Diagnosis, Treatment Outcome, and Prognosis Prediction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2016-10-30', 'studyFirstSubmitQcDate': '2017-02-14', 'lastUpdatePostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline PET/MR parameters at 2 months after treatment', 'timeFrame': '2 months after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MR/PET', 'Non-small cell lung cancer (NSCLC)'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'It is a study that hypothesize that MR/PET can have better information than current CT image study, about the medical or surgical treatment outcome of lung cancer', 'detailedDescription': 'The investigators analyze tumor size、ADCmean、ADCmin、DCE、SUVmax、SUVmin、etc in MR/PET study，to compare its efficacy with other image studies in tumor malignancy grade, systemic involvement detection, treatment outcome after medical target therapy and treatment outcome after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: \\> 20 years old.\n2. Patients have confirmed lung cancer by histopathological methods (fiber, bronchoscopy, lung biopsy, open chest biopsy, pleural effusion exfoliated cells, sputum exfoliated cells)\n3. Patients voluntarily to join this study and signed informed consents.\n\nExclusion Criteria:\n\n1. Any body metal implants (pacemaker implantation, nerve stimulator, vascular stent, aneurysm clip, eye foreign body, the inner metal prosthesis) or artificial heart valves\n2. Patients with claustrophobia to MRI examination\n3. Patients who are reluctant to comply with follow-up and subsequent examination\n4. The other condition that do not meet the inclusion criteria.\n5. Pregnancy.\n6. Age \\< 20 years old.'}, 'identificationModule': {'nctId': 'NCT03053804', 'briefTitle': 'Clinical Application of MR-PET in Non-small Cell Lung Cancer: Diagnosis, Treatment Outcome, and Prognosis Prediction', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Clinical Application of MR-PET in Non-small Cell Lung Cancer: Diagnosis, Treatment, Outcome, and Prognosis Prediction', 'orgStudyIdInfo': {'id': '201501073RINA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MR/PET', 'description': 'hypothesize that MR/PET can have better information than current CT image study', 'interventionNames': ['Radiation: MR/PET']}], 'interventions': [{'name': 'MR/PET', 'type': 'RADIATION', 'description': 'MR/PET with contrast media and FDG-18', 'armGroupLabels': ['MR/PET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yeun-Chung Chang, MD', 'role': 'CONTACT', 'email': 'ycc5566@ntu.edu.tw', 'phone': '02-23123456*65566'}], 'facility': 'National Taiwan University Hospital'}], 'centralContacts': [{'name': 'Yeun-Chung Chang', 'role': 'CONTACT', 'email': 'ycc5566@ntu.edu.tw', 'phone': '02-23123456*65566'}, {'name': 'Yu-Sen Huang', 'role': 'CONTACT', 'email': 'yusen0814@gmail.com', 'phone': '02-23123456*65566'}], 'overallOfficials': [{'name': 'Yeun-Chung Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Taiwan University Hospital, Yun-Lin Branch', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}