Radiomics for Distinguishing Benign and Malignant Lung Nodules

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

Differentiating between benign (non-cancerous) and malignant (cancerous) pulmonary nodules is a critical step in determining appropriate patient management and cancer treatment planning. Conventional evaluation using chest computed tomography (CT) relies on visual inspection of features such as size, shape, and borders; however, benign and malignant nodules frequently exhibit overlapping characteristics, which often necessitates invasive biopsy procedures.

Radiomics is an emerging analytical technique that extracts high-dimensional quantitative data from standard medical images, including tissue texture, density patterns, and complex spatial features, that cannot be detected by visual inspection alone.

The purpose of this observational study is to evaluate the utility of CT-derived radiomics combined with machine learning algorithms to non-invasively differentiate between benign and malignant pulmonary nodules. Researchers will extract quantitative imaging features from chest CT scans of patients presenting with pulmonary nodules measuring less than 5 cm to train and validate predictive machine learning models, with the goal of improving non-invasive diagnostic accuracy and reducing unnecessary biopsy procedures.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients presenting with pulmonary nodules measuring less than 5 cm in diameter.

Chest computed tomography (CT) scan acquired within the preceding 1 year.

Disqualifiers

Patients with pulmonary nodules measuring greater than 5 cm in diameter.

Chest computed tomography (CT) scan obtained more than 3 years prior.

Low-quality or artifact-compromised CT images unsuitable for radiomic feature extraction.

Trial population

Patients presenting to the Department of Diagnostic and Interventional Radiology at Assiut University Hospitals and the South Egypt Cancer Institute who have confirmed pulmonary nodules measuring less than 5 cm on chest computed tomography (CT) scans acquired within the preceding year.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

255 Participants
are grouped into 1 trial group
Group A: Patients with Pulmonary Nodules

Trial outcomes

Primary outcomes

1

Area Under the Receiver Operating Characteristic Curve (AUC) of the CT Radiomics Model

The primary outcome is the discriminatory performance of the machine learning-based radiomics model in differentiating benign from malignant pulmonary nodules, quantified by the Area Under the Receiver Operating Characteristic Curve (AUC). AUC values range from 0.5 (no discrimination / performance equal to chance) to 1.0 (perfect diagnostic discrimination). Classification accuracy will be validated against histopathological confirmation or established clinical and radiological reference standards.

Time frame
Baseline

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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