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

NCT ID: NCT04241614

Last Updated: 2022-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

626 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-15

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Cancer Image, Body

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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The First Hospital of Ji Lin University

CT data and corresponding CT raw data of patients with lung nodule will be collected.

No interventions

Intervention Type OTHER

No interventions

Interventions

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No interventions

No interventions

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

Neusoft Medical Systems Co., Ltd.

UNKNOWN

Sponsor Role collaborator

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

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Di Dong

Associate Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yali Zang, Ph.D.

Role: STUDY_DIRECTOR

Institute of Automation, Chinese Academy of Sciences

Locations

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The First Hospital of Ji Lin University

Changchun, Jilin, China

Site Status

Countries

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China

References

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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. No abstract available.

Reference Type BACKGROUND
PMID: 29159886 (View on PubMed)

Related Links

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Other Identifiers

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CASMI001

Identifier Type: -

Identifier Source: org_study_id

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