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Status unknownNCT04034667Updated Apr 1, 2020

Study of CT and MR in the Lung Cancer

An observational study in Lung Cancer Squamous Cell, CT and Genes, sponsored by Henan Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-04-01.

Sponsored by Henan Cancer Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 80 Years
Sex
All
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Study summary

Lung cancer is one of the leading causes of cancer-related deaths in China. Despite advances in systemic therapy and improvement nonsurvival rates for patients with advanced lung cancer, morbidity and mortality remain high.

Recently, many studies reported that patients with positive driving genes such as EGFR(epidermal growth factor receptor,EGFR), ALK(anaplastic lymphoma kinase,ALK), ROS1(c-ros oncogene 1 receptor,ROS1), BRAF (V-raf murine sarcoma viral oncogene homolog B1, BRAF)and so on have clearly targeted drugs, which bring survival benefits to patients. However, about half of patients still lack a clear driving gene target, which may have improved survival due to higher response rates to radiation therapy and other chemotherapy medications.

Development of noninvasive imaging biomarkers such as CT (computed tomography,CT)and MRI (magnetic resonance imaging,MRI)may not only evaluate the response to therapy ,but also could predict the efficacy of drug therapy and whether the driving gene is positive or not, through analysing the relationship between clinical related data and imaging features to find the imaging characteristics for making clinical decisions, and, consequently, contribute to an improved prognosis.

Read the detailed description

To explore the value of CT and MR using multiple sequences, including T2-TSE-BLADE, T2 maps StarVIBE, and iShim-DWI in evaluating the driving genes and prediction of response to therapy and OS in patients with lung cancer.

Patients with biopsy-proven lung cancer were prospectively enrolled for imaging on CT and a 3T MRI scanner . The MRI protocol included T2-TSE-BLADE, T2 maps,iShim-DWI and StarVIBE sequences, and so on. Patients received treatment according to NCCN( National Comprehensive Cancer Network) guideline. CT and MRI features were analyzed to find the correlation between pretreatment imaging features and driving genes and therapy response. The study will include 400 patients. Inter-reader agreements of TN staging were analyzed excellent for CT and MRI. Diagnostic accuracy of CT and MRI will be calculated separately.

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Conditions studied

  • Lung Cancer Squamous Cell
  • CT
  • Genes
  • Response
  • MRI

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Keywords

  • Lung Cancer
  • Imaging features
  • Driving genes
  • Prediction
  • Therapy response
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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 400 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 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 80 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Subjects with biopsy-proven lung cancer will receive treatment

Inclusion criteria

  1. Consecutive patients with preoperative pathologically con-firmed lung cancer by endoscopy and preoperative imaging data were included.
  2. No contraindications for MRI examination. No contraindications for iodinated contrast.
  3. The patients participate in this study with informed consent.

Exclusion criteria

Exclusion Criteria:

  1. The patients couldn't performed MSCT or MR scanning or artefacts affect the evaluation.
  2. The patients are extremely anxious and uncooperative about surgery or neoadjuvant therapy .
  3. PatientsThe patients refuse to participate in the project.
  4. Other situations considered by investigators not meet the inclusion criteria.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Interventions

  • OtherNo intervention

    No intervention

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What researchers measure

Primary outcomes

  1. Study of relationship between clinical related data(driving genes and response) and imaging features(MSCT and MRI) in lung Cancer

    Retrospectively reviewed data for patients diagnosed with lung cancer . All patients had received a histopathologic diagnosis of lung cancer based on bronchoscopic, percutaneous needle-guided, or surgical biopsies and had undergone gene mutation studies. Analysed the relationship between clinical related data(driving genes and response) and imaging features.

    Time frame: up to 2 year

  2. MSCT and MRI prediction of prognosis in lung cancer

    To construct a model,a depth convolution neural network based on MSCT and multi-modal MR quantitative images which can automatically mine key images characterization, combined with imaging features,driving genes and prognosis,could further help to improve the prediction of response and OS of lung cancer treated with systematic therapy .

    Time frame: up to 2 year

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Study locations

1 of 1 sites recruiting
  • Henan Cancer Hospital
    Zhengzhou, China
    Recruiting
08

References and documents

Publications

  • Shi L, Rong Y, Daly M, Dyer B, Benedict S, Qiu J, Yamamoto T. Cone-beam computed tomography-based delta-radiomics for early response assessment in radiotherapy for locally advanced lung cancer. Phys Med Biol. 2020 Jan 10;65(1):015009. doi: 10.1088/1361-6560/ab3247. PubMed 31307024 ↗
  • Lee G, Lee HY, Park H, Schiebler ML, van Beek EJR, Ohno Y, Seo JB, Leung A. Radiomics and its emerging role in lung cancer research, imaging biomarkers and clinical management: State of the art. Eur J Radiol. 2017 Jan;86:297-307. doi: 10.1016/j.ejrad.2016.09.005. Epub 2016 Sep 10. PubMed 27638103 ↗
  • Akinci D'Antonoli T, Farchione A, Lenkowicz J, Chiappetta M, Cicchetti G, Martino A, Ottavianelli A, Manfredi R, Margaritora S, Bonomo L, Valentini V, Larici AR. CT Radiomics Signature of Tumor and Peritumoral Lung Parenchyma to Predict Nonsmall Cell Lung Cancer Postsurgical Recurrence Risk. Acad Radiol. 2020 Apr;27(4):497-507. doi: 10.1016/j.acra.2019.05.019. Epub 2019 Jul 6. PubMed 31285150 ↗
  • Seki S, Fujisawa Y, Yui M, Kishida Y, Koyama H, Ohyu S, Sugihara N, Yoshikawa T, Ohno Y. Dynamic Contrast-enhanced Area-detector CT vs Dynamic Contrast-enhanced Perfusion MRI vs FDG-PET/CT: Comparison of Utility for Quantitative Therapeutic Outcome Prediction for NSCLC Patients Undergoing Chemoradiotherapy. Magn Reson Med Sci. 2020 Feb 10;19(1):29-39. doi: 10.2463/mrms.mp.2018-0158. Epub 2019 Mar 18. PubMed 30880291 ↗
  • Ciliberto M, Kishida Y, Seki S, Yoshikawa T, Ohno Y. Update of MR Imaging for Evaluation of Lung Cancer. Radiol Clin North Am. 2018 May;56(3):437-469. doi: 10.1016/j.rcl.2018.01.005. PubMed 29622078 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2020, 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
NCT04034667
Lead sponsor
Henan Cancer Hospital
Responsible party
Sponsor
First posted
Jul 26, 2019
Start date
Sep 1, 2019
Primary completion
Dec 1, 2023 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
Apr 1, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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