Data collection for development of a software program to detect pulmonary TB from chest X-Rays
- Conditions
- Health Condition 1: null- suspected and diagnosed cases of TB
- Registration Number
- CTRI/2017/09/009722
- Lead Sponsor
- Philips India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
Chest x-rays with no abnormality, lesions suggestive of pulmonary tuberculosis (both active and inactive) and also with lesions that can cause a false positive radiological
diagnosis of PTB will be required to construct the databases and consequently the algorithm.
The specific criteria are:
(i) Subject more than 18 years and less than 70 years of age who underwent digital chest X-Ray imaging using Philips Digital Diagnost• Release 1.5 and Philips Optimus Release 1.5
(ii) Normal subjects: Retrospective data captured using Philips DigitalDiagnost• x-ray system from the clinical site will be used after deidentification for this group and no subjects will be recruited.
(iii) Subjects with old (passive/ inactive) lesions: Subjects with self-reported history of pulmonary tuberculosis disease and treatment ceased not less than 2 years before the study with no relapse in the meantime and confirmed to be clinically free of disease as being free of symptoms and a negative sputum smear and/or culture sensitivity testing (de-identified test result to be attached with completed CRF) and with radiological abnormality in the chest x-ray
Radiological feature may include:
ï?§Dense pulmonary nodules, with or without visible calcification in hilar area /upper lobes Smaller nodules, with or without fibrotic scars, in upper lobes (Well-demarcated, sharp (â??hardâ??) margins of nodules and fibrotic lesions)
Upper-lobe volume loss Pleural scarring
Calcified nodular lesions (calcified granuloma)
Apical pleural thickening and others
(iv) Subjects with active pulmonary TB: Subjects with clinical signs and symptoms of pulmonary tuberculosis and confirmed to be suffering from pulmonary tuberculosis with a positive sputum smear and/or culture sensitivity testing (de-identified test result to be attached with completed CRF). The cases should contain a mix of â??typicalâ?? and â??atypicalâ?? PTB chest x-ray pictures.
Clinical symptoms / physical findings: one or more of: Cough / Production of sputum/ Hemoptysis / Pleuritic pain / Dyspnea.
Radiological patterns on chest x-ray:
Radiological features, viz.:
ï?§miliary, hilar or paratracheal lymphadenopathy
ï?§with or without parenchymal involvement,
ï?§pleural effusion and fibrocaseous cavitatory lesions.
middle or lower lung zone infiltrate, with or without associated with ipsilateral hilar adenopathy.
Atelectasis Cavitation (especially at apical and posterior segments of RUL and the LUL).
Calcification.
Intra- (or extra-) thoracic lymphatic involvement. Patchy bronchopneumonia.
â??Miliaryâ?? pattern. â?¦ and others
(v) Subjects whose chest-xray â??mimicsâ?? PTB (pneumonia, etc.): These subjects need to be confirmed as not suffering from PTB with a negative sputum smear and/or culture sensitivity testing and the accurate diagnosis should be established. The recruitment of these subjects will be based on clinical suspicion of the investigators and some reclassification may be needed based on the final diagnosis (e.g. if such a subject is diagnosed to be suffering from PTB instead of suspected community acquired bacterial pneumonia).
(vi) Subjects should be able to freely consent to participate in the study
(i) Subjects unable to provide free and informed consent.
(ii) Subjects with obvious thoracic deformities e.g. kyphosis, scoliosis or any previous thoracic surgery/injury that would have resulted in departure of the chest-xray from normal overall shape.
(iii) Subjects with implants/devices in the thoracic region; e.g. central venous line, intercostal drainage tube, cardiac pacemaker etc.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Transfer of the existing data as describedTimepoint: 6 Months
- Secondary Outcome Measures
Name Time Method Completion of the questionnaire by the patientTimepoint: 6 Months