Idiopathic Pulmonary Fibrosis Clinical Trial
Official title:
An In Silico Trial to Evaluate Prospectively the Performance of a Radiomics Algorithm for UIP Compared to Medical Doctors
| NCT number | NCT05784207 |
| Other study ID # | ISTRU |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 1, 2017 |
| Est. completion date | December 30, 2021 |
| Verified date | March 2023 |
| Source | Maastricht University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to compare AI performance to doctor's performance in the evaluation of IPF/UIP and ILDs without UIP(proven by biopsy).
| Status | Completed |
| Enrollment | 145 |
| Est. completion date | December 30, 2021 |
| Est. primary completion date | December 30, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - the availability of non-contrast-enhanced HRCT Exclusion Criteria: - the use of contrast enhancement - images containing metal or motion artifacts - Images reconstructed with a slice thickness larger than 1.5 mm |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Maastricht University | Maastricht | Limburg |
| Lead Sponsor | Collaborator |
|---|---|
| Maastricht University |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Comparing the performance of radiomics algorithm to that of individual doctor | Correctness of the diagnosis - the most probable thin-section pattern (dichotomous outcome: yes or no) | June 2021 | |
| Other | Comparing the reproducibility of diagnosis between the doctors | Measuring the concordance in diagnosis in between the physicians, and for each physician separately, using the Concordance correlation coefficient. | June 2021 | |
| Primary | The performance of Radiomics algorithm compared to the ground truth | Reporting the performance measure: accuracy | May 2021 | |
| Secondary | Comparing the performance of the radiomics algorithm to that of physicians | Correctness of the diagnosis - the most probable thin-section pattern (dichotomous outcome: yes or no) | June 2021 |
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