NCT04034667

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 1, 2020

Status Verified

July 1, 2019

Enrollment Period

4.3 years

First QC Date

July 17, 2019

Last Update Submit

March 31, 2020

Conditions

Keywords

Lung CancerImaging featuresDriving genesPredictionTherapy response

Outcome Measures

Primary Outcomes (2)

  • 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.

    up to 2 year

  • 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 .

    up to 2 year

Interventions

No intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with biopsy-proven lung cancer will receive treatment

You may qualify if:

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

You may not qualify if:

  • The patients couldn't performed MSCT or MR scanning or artefacts affect the evaluation.
  • The patients are extremely anxious and uncooperative about surgery or neoadjuvant therapy .
  • PatientsThe patients refuse to participate in the project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 31307024BACKGROUND
  • 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.

    PMID: 27638103BACKGROUND
  • 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.

    PMID: 31285150BACKGROUND
  • 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.

    PMID: 30880291BACKGROUND
  • 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.

    PMID: 29622078BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 26, 2019

Study Start

September 1, 2019

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

April 1, 2020

Record last verified: 2019-07

Locations