CTRI/2017/09/009722
Completed
未知
Data collection for algorithmic identification of pulmonary TB from chest X-Rays - NA
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Philips India Limited
- Enrollment
- 400
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •(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.
Outcomes
Primary Outcomes
Not specified
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