The Role of Quantitative CT and Radiomic Biomarkers for Precision Medicine in Pulmonary Fibrosis

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06323876
Status
Recruiting
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Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
40 Years - 101 Years
Healthy Volunteers
Not accepted

Interventions

  • HRCT — DIAGNOSTIC_TEST
    High resolution computed tomography (HRCT) scan is a medical imaging technique used to obtain detailed internal images of the body. HRCT images will be obtained at 0 and 12 months.
  • Blood Draw — DIAGNOSTIC_TEST
    During blood draw, someone uses a needle to take blood from a vein, usually in your arm.

Study Details

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.

Key Dates

Start date
Jun 20, 2024
Status verified
Aug 2024
Primary completion
May 31, 2028
Completion
May 31, 2029

Study Design

Enrollment
160 participants (estimated)

Arms

  • Arm: University of Chicago
    This cohort will have prior consent to the Natural History of Interstitial Lung Disease, which is an ongoing, longitudinal cohort of patients with clinically diagnosed ILD, including IPF. Patients are recruited from University of Chicago Interstitial Lung Disease Program during their clinic visit. Blood, plasma, and serum samples are collected upon enrollment and stored in a biorepository at University of Chicago. Subsets of patients have repeat blood draw at return clinic visits for specific research studies. The investigators propose collection of 1-year HRCTs, FVC, and DLCO.
  • Arm: University of Virginia
    This cohort will have prior consent to the Natural History of Interstitial Lung Disease, which is an ongoing, longitudinal cohort of patients with clinically diagnosed ILD, including IPF. Patients are recruited from the UVA Interstitial Lung Disease Program during their clinic visit. Blood, plasma, and serum samples are collected upon enrollment and stored in a biorepository at UVA (Pinn Hall RM#2232B, IRB#20937). Subsets of patients have repeat blood draw at return clinic visits for specific research studies. The investigators propose collection of 1-year HRCTs, FVC, and DLCO.

Primary Outcome Measure

Derivation of DTA in IPF only cases from the PFF-PR and its associations with disease severity and outcomes. [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22908
Roselove Asare, MA
[email protected]
434-243-6074
Diana Hsu, MA
[email protected]
Imre Noth, MD (PRINCIPAL_INVESTIGATOR)
John Kim, MD (SUB_INVESTIGATOR)

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University of Virginia· Charlottesville, VA

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