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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial population

patients suspected or confirmed to have fibrosis-related diseases

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: 68Ga-1A12 PET

Trial outcomes

Primary outcomes

1

Diagnostic efficacy, survival analysis

sensitivity, specificity, accuracy, positive and negative predictive values, ROC curve analysis,

Time frame
Completed within half year after end of the study

Secondary outcomes

Other outcomes

Sponsors and contacts

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