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

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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 and posing challenges for systemic, multi-target quantitative evaluation .

Positron Emission Tomography (PET), as a molecular imaging technique, enables non-invasive visualization of the distribution and concentration of specific biomolecules in vivo through radionuclide-labeled targeted probes, thereby reflecting the pathophysiological state of diseases [4]. In recent years, the development of novel PET probes targeting key fibrosis-related targets (e.g., fibroblast-activated protein, collagen) has become a research hotspot . Among these, the disc domain receptor, a tyrosine kinase receptor activated by collagen, exhibits significantly high expression in fibrotic tissues. Unlike the rapid and transient activation pattern of classical receptor tyrosine kinases (RTKs), the disc domain receptor demonstrates a slow and sustained phosphorylation characteristic ("slow-on slow-off") after binding to collagen. This property aligns well with its biological role in maintaining continuous signaling during chronic fibrosis . Therefore, molecular imaging probes targeting the disc domain receptor theoretically enable specific identification of active fibrotic lesions and reveal their molecular activity levels.

68Ga-1A12 is a PET imaging agent targeting the discoid domain receptor family. Preliminary studies have demonstrated its excellent targeting affinity in fibrosis models and certain clinical cases. Compared to conventional imaging that only reflects morphological changes, 68Ga-1A12 PET holds two major potential breakthroughs: first, the early detection of metabolically active fibrotic lesions before significant anatomical alterations occur; and second, the longitudinal and objective monitoring of fibrosis activity through semi-quantitative parameters such as Standardized Uptake Value (SUV), thereby providing a novel perspective for disease staging and therapeutic evaluation.

However, there is currently a lack of prospective clinical evidence regarding the systemic diagnostic efficacy, differential value, and predictive capacity for therapeutic response of 68Ga-1A12 PET in human multi-organ fibrotic diseases. Clarifying its clinical application sensitivity, specificity, and prognostic relevance is an indispensable key step in advancing this technology from basic research to clinical translation.

In conclusion, this study aims to systematically evaluate the clinical value of 68Ga-1A12 PET in identifying active lesions, differential diagnosis, and predicting anti-fibrotic efficacy in fibrosis-related diseases through a prospective clinical study, thereby providing high-level evidence-based medical support for the standardized application of this technology.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400010
        • Daping Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients suspected or confirmed to have fibrosis-related diseases

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic efficacy, survival analysis
Time Frame: Completed within half year after end of the study
sensitivity, specificity, accuracy, positive and negative predictive values, ROC curve analysis,
Completed within half year after end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 8, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2026015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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