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

NCT07459205 | Not Yet Recruiting

• 1 other identifier: 2026015
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Fibrosis

Keywords

PET; 68Ga-1A12; Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic efficacy, survival analysis

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

  Completed within half year after end of the study

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients suspected or confirmed to have fibrosis-related diseases

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

Study Sites (1)

Daping Hospital

Chongqing, Chongqing Municipality, 400010, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

histopathological findings obtained from biopsy or resected surgical specimens

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiao Chen, PH .D

CONTACT

15922970174; xiaochen229@tmmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nuclear Medicine Department

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)