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OpenTrials
Completed

NCT Number: NCT04241614

Classification of Benign and Malignant Lung Nodules Based on CT Raw Data

The employ of medical images combined with deep neural networks to assist in clinical diagnosis, therapeutic effect, and prognosis prediction is nowadays a hotspot. However, all the existing methods are designed based on the reconstructed medical images rather than the lossless raw data. Considering that medical images are intended for human eyes rather than the AI, we try to use raw data to predict the malignancy of pulmonary nodules and compared the predictive performance with CT. Experiments will prove the feasibility of diagnosis by CT raw data. We believe that the proposed method is promising to change the current medical diagnosis pipeline since it has the potential to free the radiologists.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Hospital of Ji Lin University

Changchun, Jilin, 130021, China

About this study

The routinely used diagnostic scheme of cancers follows the process of signal-to-image-to-diagnosis. It is essential to reconstruct the visible images from the signal of medical device so that the human doctor can perform diagnosis. However, the huge amount of information inside the signal is not optimally mined, which causes the current unsatisfactory performance of image based diagnosis.

In this clinical trial, we will develop an AI based diagnostic scheme for lung nodules directly from the signal (raw data) to diagnosis, skipping the reconstruction step. In this trial, we will focus on the discrimination of malignant from benign lung nodules. We will collect a dataset of patients who are screened out lung nodules. All patients undergo preoperative CT scan (raw data and CT images available) and have pathologically confirmed result of the nodules. We will build a model using only raw data for diagnosis of the lung nodules. Moreover, another model from CT image will be built for comparison.

Furthermore, we will perform follow-up on these patients and build a model based on CT raw data for prognosis analysis of lung cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are screened out lung nodule.
  • The CT data and corresponding CT raw data are available before the surgery.
  • Final pathology diagnosis of the malignancy of the nodule is available.

Exclusion criteria

  • Previous history of lung malignancies.
  • Artifacts on CT images seriously deteriorating the observation of the lesion.
  • The time interval between CT scan and pathology diagnosis is more than 4 weeks.

Treatment and study plan

No interventions

Other

No interventions

Primary outcomes

  1. Area under the receiver operating characteristic curve (ROC)

    Time frame: 8 months

    Area under curve (AUC) of raw data in discriminating malignant nodules from benign nodules.

  2. Disease free survival

    Time frame: 5 years

    The association between raw data and disease free survival (DFS), which defined as the time from the beginning of diagnosis of lung cancer to the confirmed time of recurrence or metastatic disease, or death occurred.

  3. Overal survival

    Time frame: 5 years

    The association between raw data and overall survival (OS), which defined as the time from the beginning of diagnosis of lung cancer to the death with any causes.

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Collaborators

  • Neusoft Medical Systems Co., Ltd.
  • The First Hospital of Jilin University

Registry information

Official study title

Comparison and Analysis of Predictive Performance of CT and Raw Data in Benign and Malignant Classification of Pulmonary Nodules

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2020
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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