MedPath

18F-FDG Metabolism Imaging Monitoring Non-small Cell Lung Cancer Curative Effect of Chemotherapy Multicenter Clinical Study

Phase 3
Conditions
Non-small-cell Lung Cancer
Interventions
Radiation: 18F-FDG
Registration Number
NCT02938546
Lead Sponsor
Shanghai Chest Hospital
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
200
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
before therapy18F-FDG18F-FDG PET/CT performed before therapy
3 days after cisplatin chemotherapy and targeted therapy18F-FDG18F-FDG PET/CT performed 3 days after chemotherapy and targeted therapy
longer time after cisplatin chemotherapy and targeted therapy18F-FDG18F-FDG PET/CT performed before the third cycle chemotherapy and the 7th week targeted therapy
Primary Outcome Measures
NameTimeMethod
Glucose metabolism discrepancy of different genotype NSCLC as Assessed by EORTC6 years
Secondary Outcome Measures
NameTimeMethod
Different genotype NSCLC metabolic response after treatment as Assessed by EORTC6 years
© Copyright 2025. All Rights Reserved by MedPath