Radiomics Model for the Diagnosis of Pneumocystis Jirovecii Pneumonia in Non-HIV Patients

Pneumocystis Jirovecii Pneumonia Clinical Trial

Official title:

Radiomics Model for the Diagnosis of Pneumocystis Jirovecii Pneumonia in Non-HIV Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05701631
• Other study ID #: S2023-006-01
• Status: Active, not recruiting
• Start date: January 15, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2023
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To evaluate the performance of radiomics in differentiating Pneumocystis jirovecii pneumonia (PCP) from other types of pneumonia and to improve the diagnostic efficacy of non-invasive tests in non-HIV patients.

Description:

Retrospective study, including non-HIV patients hospitalized for suspected PCP from January 2010 to December 2022. The included patients were randomized in a 7:3 ratio into training and validation cohorts. Radiomic features were extracted from semi-automatically identified infected areas in computed tomography (CT) scans and used to construct a radiomic model, which was then compared to a clinical-imaging model built with clinical and semantic CT features in terms of diagnostic performance of PCP. The combination of the radiomic model and serum β-D-glucan levels was also evaluated for PCP diagnosis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged over eighteen years;

• presence of an underlying disease known to be associated with PCP

• symptoms of lower respiratory tract infection, such as fever, cough or dyspnea

• signs of lung infection on high resolution CT at the on-set of the disease

• received BAL examination within three days after CT scans

• underwent qPCR and IF staining tests on the BAL fluid sample.

Exclusion Criteria:

• with HIV infection

• taking trimethoprim-sulfamethoxazole for prophylaxis

• undiagnosed by qPCR and IF staining tests

Related Conditions & MeSH terms

• Pneumocystis Jirovecii Pneumonia
• Pneumonia
• Pneumonia, Pneumocystis

Intervention

Diagnostic Test:
• Radiomic model
Radiomic model for PCP diagnosis

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the diagnostic performance of radiomic model in the PCP diagnosis	The included patients were randomized in a 7:3 ratio into training and validation cohorts. Radiomic features were extracted from semi-automatically identified infected areas in computed tomography (CT) scans and used to construct a radiomic model. Then, the area under the curve (AUC) of the receiver operating characteristic (ROC) curves were calculated and used to evaluate the diagnostic performance (accuracy, sensitivity, specialty, positive predictive value, negative predictive value) of the model for PCP diagnosis in both training and validation cohorts.	6 months