Clinical trial NCT02938546: 18F-FDG Metabolism Imaging Monitoring Non-small Cell Lung Cancer Curative Effect of Chemotherapy Multicenter Clinical Study
Official title: 18F-FDG Metabolism Imaging Monitoring Non-small Cell Lung Cancer Curative Effect of Chemotherapy Multicenter Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-small-cell Lung Cancer
Keywords: Non-small-cell lung cancer
18F-FDG PET/CT
treatment response assessment
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: The subject is going to use 18F-FDG PET/CT to assess different genetic NSCLC metabolism after cisplatin chemotherapy and targeted therapy, define the assessment criteria for the role of 18F-FDG PET/CT in NSCLC treatment respone and at last build multi-centre clinical trial platform of molecular classification and molecular imaging for cancer chemotherapy assessment.

Detailed description: Non-small-cell lung cancer (NSCLC) is the first leading cause of cancer death in the world. Systemic chemotherapy has contributed to the only choice for more than 50% NSCLC patients. The genetic abnormalities lead to different therapy response to the same chemotherapy scheme in NSCLC patients. At present, early assessment and prediction is the key for optimize NSCLC therapy. 18F-FDG PET/CT is a noninvasive cell metabolism reaction molecular imaging technology which can assess cancer glucose metabolism sensitively and react cancer proliferation to some degree. Hence 18F-FDG PET/CT may be used to assess NSCLC therapy response noninvasively. It is a reliable method to individualize NSCLC treatment clinically by define the appropriate metabolism response cut-off values and assess time points of 18F-FDG PET/CT in predicting different genetic NSCLC patients.The subject is going to use 18F-FDG PET/CT to assess different genetic NSCLC metabolism after cisplatin chemotherapy and targeted therapy, define the assessment criteria for the role of 18F-FDG PET/CT in NSCLC treatment respone and at last build multi-centre clinical trial platform of molecular classification and molecular imaging for cancer chemotherapy assessment.

Eligibility criteria: Inclusion Criteria:

* pathological biopsy for NSCLC; stage III-IV; plan to palliative chemotherapy (such as neoadjuvant chemotherapy, convention and targeted therapy) due to unable to surgery; not radiation therapy or chemotherapy for 6 months before enrollment; the predictive survival time more than half year;

Exclusion Criteria:

* with diabetes and chest radiotherapy chronic disease; brain metastases patients; with secondary primary maligmant cancer in 5 years

Primary outcomes:
measure: Glucose metabolism discrepancy of different genotype NSCLC as Assessed by EORTC
timeFrame: 6 years
Secondary outcomes:
measure: Different genotype NSCLC metabolic response after treatment as Assessed by EORTC
timeFrame: 6 years
Other outcomes:
measure: Time points of predictive specific genotype NSCLC glucose metabolic response by statistics
timeFrame: 6 years
Locations:
Study officials:
affiliation: Shanghai Chest Hospital of Shanghai Jiao Tong University
name: Wenhui Xie, PHD
role: STUDY_DIRECTOR
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