Development of FAPI PET as a Non-invasive Biomarker of Pulmonary Fibrogenesis

Conditions

• Fibrosis Lung

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• FAPI tracer — DRUG
  radioactive substance called a "tracer" injected into the arm
• PET/MRI — DEVICE
  positron emission tomography (PET) takes pictures of inside of the body

Study Details

The goal of this clinical trial is to gain more information about how fibroblast activation protein inhibitor (FAPI) binds to a certain type of cells in fibrotic lung tissue and how this information can be used to better diagnose and track fibrotic lung disease activity. Participants will undergo up to 4 PET/MRI scans using the FAPI radiotracer.

Key Dates

Start date

Nov 19, 2025

Status verified

Mar 2026

Primary completion

Sep 30, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

50 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Group A - 3 scans
  Participants undergo three PET/MRI scans using the FAPI radiotracer. They will have 3 research visits, and each visit may last up to 2.5 hours.
• Experimental: Group B - 2 scans
  Participants undergo two PET/MRI scans using the FAPI radiotracer. They will have 2 research visits, and each visit may last up to 2.5 hours.
• Experimental: Group B Crossover
  Participants undergo two additional PET/MRI scans using the FAPI radiotracer. They will have 2 additional research visits, and each visit may last up to 2.5 hours.

Primary Outcome Measure

Change in FAPI uptake [ Time Frame: Baseline to 6 months ]

Central Contacts

• Radiology Studies
  608-282-8349
  [email protected]

Locations (1)

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