AzTrials
AzTrials

Pulmonary FibrosisNCT07459205

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

An observational study of Pulmonary Fibrosis, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Fibrosis
How many people
50 participants
Where
1 siteChina
Study dates
1 Mar 2026to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients suspected or confirmed to have fibrosis-related diseases

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiao Chen, PH .D contact

15922970174

xiaochen229@tmmu.edu.cn

China1 site
  • Daping Hospital

    Chongqing, Chongqing Municipality, 400010

    Daping Hospital xiao chen, PH.D, 15922970174, xiaochen229@tmmu.edu.cn

Other trials in China

About this study

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.

Read the 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.

Keywords
PET, 68Ga-1A12, Pulmonary Fibrosis
Medical subject headings
Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07459205
Study groupRoleWhat they receive
68Ga-1A12 PETEvaluation 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic efficacy, survival analysis

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

    Measured: Completed within half year after end of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07459205
Sponsor's protocol ID
2026015
Status last verified
Mar 2026
First submitted
4 Mar 2026
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Fibrosis, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiao Chen, PH .D (15922970174, xiaochen229@tmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic efficacy, survival analysis (time frame: Completed within half year after end of the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in