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Starting soon Observational

Clinical Application of 68Ga-1A12 PET in Fibrosis-related Diseases

NCT07459205 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2026-03-01
Last updated
2026-03-11

Condition(s) studied

Pulmonary Fibrosis

Study summary

Organ fibrosis is a common end-stage pathological change in various chronic diseases, characterized by excessive deposition of extracellular matrix (ECM) and disruption of tissue architecture, which can involve multiple organs such as the heart, liver, lungs, kidneys, and intestines. Although the pathogenic triggers vary, the core molecular mechanisms are highly conserved, involving sustained activation of signaling pathways such as transforming growth factor-β (TGF-β), transdifferentiation of fibroblasts into myofibroblasts, and processes like epithelial-mesenchymal transition (EMT) . Currently, histopathological biopsy remains the gold standard for the diagnosis and staging of fibrosis, but its inherent invasiveness, sampling errors, and procedural risks limit its repeated application and dynamic monitoring .

In clinical practice, functional imaging modalities such as high-resolution computed tomography (CT) and ultrasonic elastography have been employed to assess fibrosis in specific organs (e.g., lungs, liver). However, these methods predominantly rely on secondary morphological or physical property alterations, exhibiting limited capacity for identifying early-stage, active molecular-level pathological processes. Additionally, they are challenging to perform for systemic, multi-target quantitative evaluation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * No gender restriction, age ≥18 years (inclusive); * patients suspected or confirmed to have fibrosis-related disease; * patients eligible for 68Ga-1A12 PET scan * Patients who can provide informed consent (signed by the participant, parent or legal representative) and consent forms in accordance with the guidelines of the clinical research ethics committee. Exclusion Criteria: * patients in critical condition requiring emergency care; * Individuals with druand/or alcohol abuse, or those with allergic predisposition; * women of childbearing potential, pregnant and lactating women; * bacterial, viral or fungal infections that require systemic treatment; * The study excluded participants deemed unsuitable by the investigators.

Primary outcome measure(s)

  • Diagnostic efficacy, survival analysis — Completed within half year after end of the study
    sensitivity, specificity, accuracy, positive and negative predictive values, ROC curve analysis,

Trial sites (1)

FacilityCityRegionStatus
Daping Hospital Chongqing Chongqing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07459205 on ClinicalTrials.gov ↗ ← All trials in China