PET Scan Tracer to Track Lung Scarring in Systemic Sclerosis
Tests a PET scan tracer in adults with systemic sclerosis lung disease.
Plain-language title generated from the registry record
Registry title: FAPI PET in Systemic Sclerosis Interstitial Lung Disease
Key facts
- Where
- Los Angeles, United StatesSee the site
- Phase
- Phase 2
Where in United States
- UCLA Division of RheumatologyLos Angeles, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of California, Los Angeles
- Trial code
- NCT07925242
- Record updated
- 9 November 2026
- Original description
This is a phase II open-label efficacy and safety study to evaluate standard of care treatment response measured by PET imaging radiotracer 68Ga-FAPI-46 in 120 subjects with SSc-ILD.Read full original descriptionShow less
PHASE II OPEN-LABEL EFFICACY AND SAFETY STUDY OF FIBROBLAST ACTIVATION PROTEIN α (FAP)-DIRECTED RADIOTRACER 68Ga-FAPI-46 AS A POSITRON EMISSION TOMOGRAPHY (PET) FUNCTIONAL RESPONSE BIOMARKER FOR SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD)
This is a phase II open-label efficacy and safety study to evaluate standard of care treatment response measured by PET imaging radiotracer 68Ga-FAPI-46 in 120 subjects with SSc-ILD.
Inclusion: Ability to provide written informed consent; Male or female > 18 years of age at the screening visit; Meets the 2013 American College of Rheumatology (ACR)/EULAR Classification Criteria for SSc; ILD confirmed by thoracic high resolution computed tomography (HRCT) at the baseline visit; Initiated or will initiate a new ILD therapy within the last 3 months +/- 1 week prior to the screening visit; If enrolled in the FAPI/PET group, women of child-bearing potential must have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnant test will be required.
Exclusion: Subjects must not have participated in another clinical trial with an investigational product within 90 days prior to enrollment and agree to abstain from such trials during the study; Prior allergic reaction to radiotracer 68Ga-FAPI-46; Unsuitable candidate for the study, based on the opinion of the Investigator (e.g., cognitive impairment), such that participation might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or complete the study; Active infectious lung disease; Current malignancy other than squamous or basal cell carcinoma; Current lung disease other than ILD (e.g., emphysema); Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.