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出境医 / 临床实验 / Accuracy of Deep-learning Algorithm for Detection and Risk Stratification of Lung Nodules

Accuracy of Deep-learning Algorithm for Detection and Risk Stratification of Lung Nodules

Study Description
Brief Summary:
Osteosarcoma is regarded as most common malignant bone tumor in children and adolescents. Approximately 15% to 20% of patients with osteosarcoma present with detectable metastatic disease, and the majority of whom (85%) have pulmonary lesions as the sole site of metastasis. Previous studies have shown that the overall survival rate among patients with localized osteosarcoma without metastatic disease is approximately 60% to 70% whereas survival rate reduces to 10% to 30% in patients with metastatic disease. Though lately, neoadjuvant and adjuvant chemotherapeutic regimens can decline the mortality rate, 30% to 50% of patients still die of pulmonary metastases. Number, distribution and timing of lung metastases are of prognostic value for survival and hence computed tomography (CT) thorax imaging still plays a vital role in disease surveillance. In the last decade, the technology of multidetector CT scanner has enhanced the detection of numerous smaller lung lesions, which on one hand can increase the diagnostic sensitivity for lung metastasis, however, the specificity may be reduced. In recent years, deep-learning artificial intelligence (AI) algorithm in a wide variety of imaging examinations is a hot topic. Currently, an increasing number of Computer-Aided Diagnosis (CAD) systems based on deep learning technologies aiming for faster screening and correct interpretation of pulmonary nodules have been rapidly developed and introduced into the market. So far, the researches concentrating on the improving the accuracy of benign/malignant nodule classification have made substantial progress, inspired by tremendous advancement of deep learning techniques. Consequently, the majority of the existing CAD systems can perform pulmonary nodule classification with accuracy of 90% above. In clinical practice, not only the malignancy determination for pulmonary nodule, but also the distinction between primary carcinoma and intrapulmonary metastasis is crucial for patient management. However, most existing classification of pulmonary nodule applied in CAD system remains to be binary pattern (benign Vs malignant), in the lack of more thorough nodule classification characterized with splitting of primary and metastatic nodule. To the best of our knowledge, only a few studies have focuses on the performance of deep learning-based CAD system for identifying metastatic pulmonary nodule till now. In this proposed study, the investigators sought to determine the accuracy and sensitivity of one computer-aided system based on deep-learning artificial intelligence algorithm for detection and risk stratification of lung nodules in osteogenic sarcoma patients.

Condition or disease Intervention/treatment
Osteogenic Sarcoma Radiation: computed tomography

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Feasibility Study: Accuracy and Sensitivity of Deep-learning Artificial Intelligence (AI) Algorithm for Detection and Risk Stratification of Lung Nodules in Osteogenic Sarcoma Patients
Actual Study Start Date : November 6, 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : January 2023
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. accuracy [ Time Frame: 3 years ]
    proportion of true results(both true positives and true negatives) among whole instances

  2. sensitivity [ Time Frame: 3 years ]
    true positive rate in percentage(%) derived by ROC analysis

  3. specificity [ Time Frame: 3 years ]
    true negative rate in percentage (%) derived by ROC analysis

  4. area under curve (AUC) [ Time Frame: 3 years ]
    area under ROC curve in percentage (%)


Secondary Outcome Measures :
  1. average number of false positives per scan (FPs/scan) [ Time Frame: 3 years ]
    FPs/scan in number (N) based on free-response receiver operating characteristic (FROC) analysis

  2. competition performance metric (CPM) [ Time Frame: 3 years ]
    Competitive performance metric (CPM) is a criterion used for CAD system evaluation. Based on FROC paradigm, CPM score is computed as an average sensitivity at seven predefined average false positive rates. CPM score ranges from 0 to 1, with higher CPM score indicating better CAD performance.


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date July 15, 2019
First Posted Date July 17, 2019
Last Update Posted Date January 27, 2021
Actual Study Start Date November 6, 2019
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2019)
  • accuracy [ Time Frame: 3 years ]
    proportion of true results(both true positives and true negatives) among whole instances
  • sensitivity [ Time Frame: 3 years ]
    true positive rate in percentage(%) derived by ROC analysis
  • specificity [ Time Frame: 3 years ]
    true negative rate in percentage (%) derived by ROC analysis
  • area under curve (AUC) [ Time Frame: 3 years ]
    area under ROC curve in percentage (%)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 17, 2019)
  • average number of false positives per scan (FPs/scan) [ Time Frame: 3 years ]
    FPs/scan in number (N) based on free-response receiver operating characteristic (FROC) analysis
  • competition performance metric (CPM) [ Time Frame: 3 years ]
    Competitive performance metric (CPM) is a criterion used for CAD system evaluation. Based on FROC paradigm, CPM score is computed as an average sensitivity at seven predefined average false positive rates. CPM score ranges from 0 to 1, with higher CPM score indicating better CAD performance.
Original Secondary Outcome Measures
 (submitted: July 15, 2019)
  • average number of false positives per scan (FPs/scan) [ Time Frame: 3 years ]
    FPs/scan in number (N) based on free-response receiver operating characteristic (FROC) analysis
  • competition performance metric (CPM) [ Time Frame: 3 years ]
    CPM in score (0-1) based on FROC analysis
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Accuracy of Deep-learning Algorithm for Detection and Risk Stratification of Lung Nodules
Official Title Feasibility Study: Accuracy and Sensitivity of Deep-learning Artificial Intelligence (AI) Algorithm for Detection and Risk Stratification of Lung Nodules in Osteogenic Sarcoma Patients
Brief Summary Osteosarcoma is regarded as most common malignant bone tumor in children and adolescents. Approximately 15% to 20% of patients with osteosarcoma present with detectable metastatic disease, and the majority of whom (85%) have pulmonary lesions as the sole site of metastasis. Previous studies have shown that the overall survival rate among patients with localized osteosarcoma without metastatic disease is approximately 60% to 70% whereas survival rate reduces to 10% to 30% in patients with metastatic disease. Though lately, neoadjuvant and adjuvant chemotherapeutic regimens can decline the mortality rate, 30% to 50% of patients still die of pulmonary metastases. Number, distribution and timing of lung metastases are of prognostic value for survival and hence computed tomography (CT) thorax imaging still plays a vital role in disease surveillance. In the last decade, the technology of multidetector CT scanner has enhanced the detection of numerous smaller lung lesions, which on one hand can increase the diagnostic sensitivity for lung metastasis, however, the specificity may be reduced. In recent years, deep-learning artificial intelligence (AI) algorithm in a wide variety of imaging examinations is a hot topic. Currently, an increasing number of Computer-Aided Diagnosis (CAD) systems based on deep learning technologies aiming for faster screening and correct interpretation of pulmonary nodules have been rapidly developed and introduced into the market. So far, the researches concentrating on the improving the accuracy of benign/malignant nodule classification have made substantial progress, inspired by tremendous advancement of deep learning techniques. Consequently, the majority of the existing CAD systems can perform pulmonary nodule classification with accuracy of 90% above. In clinical practice, not only the malignancy determination for pulmonary nodule, but also the distinction between primary carcinoma and intrapulmonary metastasis is crucial for patient management. However, most existing classification of pulmonary nodule applied in CAD system remains to be binary pattern (benign Vs malignant), in the lack of more thorough nodule classification characterized with splitting of primary and metastatic nodule. To the best of our knowledge, only a few studies have focuses on the performance of deep learning-based CAD system for identifying metastatic pulmonary nodule till now. In this proposed study, the investigators sought to determine the accuracy and sensitivity of one computer-aided system based on deep-learning artificial intelligence algorithm for detection and risk stratification of lung nodules in osteogenic sarcoma patients.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population This is a single institutional retrospective cohort study of patients diagnosed with osteogenic sarcoma between the year 2000 and 2018. All patients' data will be retrieved via the electronic patient database of our institution. Patient demographics, imaging and histological data, disease and treatment history will be recorded, including age at onset, details of chemotherapy, time interval of pulmonary metastasis from diagnosis, surgery for the primary bony tumor, subsequent pulmonary metastatectomy if performed, the length of survival, clinical outcome and so on.
Condition Osteogenic Sarcoma
Intervention Radiation: computed tomography
thoracic CT examinations for pre-treatment staging and/or subsequent post-treatment follow-up.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 15, 2019)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2023
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with histologically confirmed osteogenic sarcoma
  • With an age younger than 18 years old.
  • Patients who underwent thin-section thoracic CT examinations for pre-treatment staging and/or subsequent post-treatment follow-up.
  • With suspicious lung nodules detected on thoracic CT images.

Exclusion Criteria:

  • Patients with concurring lesions that may influence analysis of lung nodules.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number NCT04022512
Other Study ID Numbers NTEC-2019-0445
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Professor Winnie W.C. Chu, Chinese University of Hong Kong
Study Sponsor Chinese University of Hong Kong
Collaborators IBM China/Hong Kong Limited
Investigators Not Provided
PRS Account Chinese University of Hong Kong
Verification Date January 2021

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