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Status unknownNCT02938546Updated Oct 21, 2016

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

A Phase 3 interventional study of 18F-FDG in Non-small-cell Lung Cancer, sponsored by Shanghai Chest Hospital. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-10-21.

Sponsored by Shanghai Chest Hospital · Phase 3, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Non-small-cell Lung Cancer

Keywords

  • Non-small-cell lung cancer
  • 18F-FDG PET/CT
  • treatment response assessment
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 200 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • with diabetes and chest radiotherapy chronic disease; brain metastases patients; with secondary primary maligmant cancer in 5 years
05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    before therapy

    18F-FDG PET/CT performed before therapy

    Radiation: 18F-FDG

  • Experimental
    3 days after cisplatin chemotherapy and targeted therapy

    18F-FDG PET/CT performed 3 days after chemotherapy and targeted therapy

    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

    Radiation: 18F-FDG

Interventions

  • Radiation18F-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.

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What researchers measure

Primary outcomes

  1. Glucose metabolism discrepancy of different genotype NSCLC as Assessed by EORTC

    Time frame: 6 years

Secondary outcomes

  1. Different genotype NSCLC metabolic response after treatment as Assessed by EORTC

    Time frame: 6 years

Other outcomes

  1. Time points of predictive specific genotype NSCLC glucose metabolic response by statistics

    Time frame: 6 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Zhao Y, Wang H, Shi Y, Cai S, Wu T, Yan G, Cheng S, Cui K, Xi Y, Qi X, Zhang J, Ma W. Comparative effectiveness of combined therapy inhibiting EGFR and VEGF pathways in patients with advanced non-small-cell lung cancer: a meta-analysis of 16 phase II/III randomized trials. Oncotarget. 2017 Jan 24;8(4):7014-7024. doi: 10.18632/oncotarget.12294. PubMed 27690345 ↗
  • Zhang T, Xie J, Arai S, Wang L, Shi X, Shi N, Ma F, Chen S, Huang L, Yang L, Ma W, Zhang B, Han W, Xia J, Chen H, Zhang Y. The efficacy and safety of anti-PD-1/PD-L1 antibodies for treatment of advanced or refractory cancers: a meta-analysis. Oncotarget. 2016 Nov 8;7(45):73068-73079. doi: 10.18632/oncotarget.12230. PubMed 27683031 ↗
  • Watanabe K, Shinkai M, Tei Y, Kaneko T. Chemotherapy in Non-Small Cell Lung Cancer Patients Receiving Oxygen Therapy. Oncol Res Treat. 2016;39(10):587-590. doi: 10.1159/000449328. Epub 2016 Sep 15. PubMed 27710970 ↗
  • Shang J, Ling X, Zhang L, Tang Y, Xiao Z, Cheng Y, Guo B, Gong J, Huang L, Xu H. Comparison of RECIST, EORTC criteria and PERCIST for evaluation of early response to chemotherapy in patients with non-small-cell lung cancer. Eur J Nucl Med Mol Imaging. 2016 Oct;43(11):1945-53. doi: 10.1007/s00259-016-3420-7. Epub 2016 May 28. PubMed 27236466 ↗
  • Ho TY, Chou PC, Yang CT, Tsang NM, Yen TC. Total lesion glycolysis determined per RECIST 1.1 criteria predicts survival in EGFR mutation-negative patients with advanced lung adenocarcinoma. Clin Nucl Med. 2015 Jun;40(6):e295-9. doi: 10.1097/RLU.0000000000000774. PubMed 25783515 ↗
  • Lee DH, Kim SK, Lee HY, Lee SY, Park SH, Kim HY, Kang KW, Han JY, Kim HT, Lee JS. Early prediction of response to first-line therapy using integrated 18F-FDG PET/CT for patients with advanced/metastatic non-small cell lung cancer. J Thorac Oncol. 2009 Jul;4(7):816-21. doi: 10.1097/JTO.0b013e3181a99fde. PubMed 19487962 ↗
  • Huang W, Zhou T, Ma L, Sun H, Gong H, Wang J, Yu J, Li B. Standard uptake value and metabolic tumor volume of (1)(8)F-FDG PET/CT predict short-term outcome early in the course of chemoradiotherapy in advanced non-small cell lung cancer. Eur J Nucl Med Mol Imaging. 2011 Sep;38(9):1628-35. doi: 10.1007/s00259-011-1838-5. Epub 2011 May 27. PubMed 21617977 ↗
  • Wijesinghe P, Bollig-Fischer A. Lung Cancer Genomics in the Era of Accelerated Targeted Drug Development. Adv Exp Med Biol. 2016;890:1-23. doi: 10.1007/978-3-319-24932-2_1. PubMed 26703796 ↗
  • Tafe LJ, Pierce KJ, Peterson JD, de Abreu F, Memoli VA, Black CC, Pettus JR, Marotti JD, Gutmann EJ, Liu X, Shirai K, Dragnev KH, Amos CI, Tsongalis GJ. Clinical Genotyping of Non-Small Cell Lung Cancers Using Targeted Next-Generation Sequencing: Utility of Identifying Rare and Co-mutations in Oncogenic Driver Genes. Neoplasia. 2016 Sep;18(9):577-83. doi: 10.1016/j.neo.2016.07.010. PubMed 27659017 ↗
  • Yuneva MO, Fan TW, Allen TD, Higashi RM, Ferraris DV, Tsukamoto T, Mates JM, Alonso FJ, Wang C, Seo Y, Chen X, Bishop JM. The metabolic profile of tumors depends on both the responsible genetic lesion and tissue type. Cell Metab. 2012 Feb 8;15(2):157-70. doi: 10.1016/j.cmet.2011.12.015. PubMed 22326218 ↗
  • Masri S, Papagiannakopoulos T, Kinouchi K, Liu Y, Cervantes M, Baldi P, Jacks T, Sassone-Corsi P. Lung Adenocarcinoma Distally Rewires Hepatic Circadian Homeostasis. Cell. 2016 May 5;165(4):896-909. doi: 10.1016/j.cell.2016.04.039. PubMed 27153497 ↗
  • Dejust S, Morland D, Fabre G, Prevost A, Papathanassiou D. 18F-FDG PET/CT Evaluation of Ceritinib Therapy in Metastatic ALK-Positive Non-small Cell Lung Cancer. Clin Nucl Med. 2016 Nov;41(11):879-880. doi: 10.1097/RLU.0000000000001361. PubMed 27607176 ↗
  • Manegold C, Dingemans AC, Gray JE, Nakagawa K, Nicolson M, Peters S, Reck M, Wu YL, Brustugun OT, Crino L, Felip E, Fennell D, Garrido P, Huber RM, Marabelle A, Moniuszko M, Mornex F, Novello S, Papotti M, Perol M, Smit EF, Syrigos K, van Meerbeeck JP, van Zandwijk N, Yang JC, Zhou C, Vokes E. The Potential of Combined Immunotherapy and Antiangiogenesis for the Synergistic Treatment of Advanced NSCLC. J Thorac Oncol. 2017 Feb;12(2):194-207. doi: 10.1016/j.jtho.2016.10.003. Epub 2016 Oct 8. PubMed 27729297 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02938546
Lead sponsor
Shanghai Chest Hospital
Responsible party
Wenhui XIE (chief physician, Shanghai Chest Hospital) — Principal investigator
First posted
Oct 19, 2016
Start date
Nov 2016
Primary completion
Jan 2023 (estimated)
Completion
Jan 2023 (estimated)
Last update
Oct 21, 2016

Study contacts

Wenhui Xie, PHD
Contact
xknuclear@163.com
+8618017321597
Wenhui Xie, PHD
study director · Shanghai Chest Hospital of Shanghai Jiao Tong University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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