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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04241614
• Other study ID #: CASMI001
• Status: Completed
• Start date: April 15, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2022
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 626
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who are screened out lung nodule.

2. The CT data and corresponding CT raw data are available before the surgery.

3. Final pathology diagnosis of the malignancy of the nodule is available.

Exclusion Criteria:

1. Previous history of lung malignancies.

2. Artifacts on CT images seriously deteriorating the observation of the lesion.

3. The time interval between CT scan and pathology diagnosis is more than 4 weeks.

Related Conditions & MeSH terms

• Image, Body
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• No interventions
No interventions

Locations

Country	Name	City	State
China	The First Hospital of Ji Lin University	Changchun	Jilin

Sponsors (3)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	Neusoft Medical Systems Co., Ltd., The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

References & Publications (1)

Kalra M, Wang G, Orton CG. Radiomics in lung cancer: Its time is here. Med Phys. 2018 Mar;45(3):997-1000. doi: 10.1002/mp.12685. Epub 2017 Dec 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the receiver operating characteristic curve (ROC)	Area under curve (AUC) of raw data in discriminating malignant nodules from benign nodules.	8 months
Primary	Disease free survival	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.	5 years
Primary	Overal survival	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.	5 years

External Links

•   LUNA2016
•   Lung Cancer