FAPI PET in Systemic Sclerosis Interstitial Lung Disease

About

Brief Summary

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.

Primary Purpose

Diagnostic

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

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 Criteria:

Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
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).
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.