NCT06323876 The Role of Quantitative CT and Radiomic Biomarkers for Precision Medicine in Pulmonary Fibrosis
| NCT ID | NCT06323876 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Virginia |
| Condition | Idiopathic Pulmonary Fibrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-06-20 |
| Primary Completion | 2028-05 |
Trial Parameters
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Brief Summary
This observational study involves obtaining 2 chest CT scans; a historical baseline CT within ±1 year of enrollment into PRECISIONS, and a follow-up CT (either historical or prospective) 12 months ± 180 days after the baseline CT. Many IPF patients will have a CT scan every 12 months for disease monitoring and cancer screening. Participants will have the option to share historical CTs only or they can choose to have a research CT done for the follow-up scan, if a scan for clinical purposes is not available.
Eligibility Criteria
Inclusion Criteria: 1. ≥ 40 years of age 2. Diagnosed with IPF according to 2018 ATS/ERS/JRS/ALAT confirmed by the enrolling investigator 3. Signed informed consent Exclusion Criteria: 1. Pregnancy or planning to become pregnant 2. Women of childbearing potential not willing to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of \<1% per year during study participation\* 3. Significant medical, surgical or psychiatric illness that in the opinion of the investigator would affect subject safety or potential to complete the research study * A woman is considered to be of childbearing potential if she is post-monarchical, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of \<1% pe