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

Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study ID
NCT07459205
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Mar 2026
Primary completion
Dec 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: 68Ga-1A12 PET
    Evaluation of 68Ga-1A12 imaging in assessing the diagnostic validity of various types of fibrosis-related diseases, including calculation of its sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy.

Primary Outcome Measure

Diagnostic efficacy, survival analysis [ Time Frame: Completed within half year after end of the study ]

Central Contacts

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