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Clinical Trials/CTRI/2017/09/009722
CTRI/2017/09/009722
Completed
未知

Data collection for algorithmic identification of pulmonary TB from chest X-Rays - NA

Philips India Limited0 sites400 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
June 11, 2018
Last Updated
4 years ago
Study Type
Observational

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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