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

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ClinicalTrials.gov Identifier: NCT02938546
Recruitment Status : Not yet recruiting
First Posted : October 19, 2016
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Wenhui XIE, Shanghai Chest Hospital

Tracking Information
First Submitted Date  ICMJE October 17, 2016
First Posted Date  ICMJE October 19, 2016
Last Update Posted Date October 21, 2016
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
Glucose metabolism discrepancy of different genotype NSCLC as Assessed by EORTC [ Time Frame: 6 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
Different genotype NSCLC metabolic response after treatment as Assessed by EORTC [ Time Frame: 6 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 17, 2016)
Time points of predictive specific genotype NSCLC glucose metabolic response by statistics [ Time Frame: 6 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE 18F-FDG Metabolism Imaging Monitoring Non-small Cell Lung Cancer Curative Effect of Chemotherapy Multicenter Clinical Study
Official Title  ICMJE 18F-FDG Metabolism Imaging Monitoring Non-small Cell Lung Cancer Curative Effect of Chemotherapy Multicenter Clinical Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Non-small-cell Lung Cancer
Intervention  ICMJE Radiation: 18F-FDG
18FDG-PET scan was performed 4 weeks before the first administration of therapy or before the third cycle chemotherapy or before the 7th week of targeted therapy and after 3 days chemotherapy and targeted therapy. The lesions were analyzed by nuclear medicine physician and calculate the metabolism response. The size of percent changes was evaluated using the EORTC (European Organization for Research and Treatment of Cancer) PET criteria by oncologist who determine whether the scheme works and the scheme should continue or change. The seleted patients were double blinded to analyse the relationship between metabolism response and chemotherapy response.
Study Arms  ICMJE
  • Active Comparator: before therapy
    18F-FDG PET/CT performed before therapy
    Intervention: Radiation: 18F-FDG
  • Experimental: 3 days after cisplatin chemotherapy and targeted therapy
    18F-FDG PET/CT performed 3 days after chemotherapy and targeted therapy
    Intervention: Radiation: 18F-FDG
  • Experimental: longer time after cisplatin chemotherapy and targeted therapy
    18F-FDG PET/CT performed before the third cycle chemotherapy and the 7th week targeted therapy
    Intervention: Radiation: 18F-FDG
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2016)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wenhui Xie, PHD +8618017321597 xknuclear@163.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02938546
Other Study ID Numbers  ICMJE WXIE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Wenhui XIE, Shanghai Chest Hospital
Study Sponsor  ICMJE Shanghai Chest Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Wenhui Xie, PHD Shanghai Chest Hospital, Shanghai Jiao Tong University
PRS Account Shanghai Chest Hospital
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP