Clinical Study on the Application of PET Probes Targeting DDR2 in the Diagnosis of Interstitial Lung Disease With Cognitive Impairment

NCT07459179 | Not Yet Recruiting

• 1 other identifier: 2025485
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

According to statistics, 45% of human disease-related deaths are associated with organ fibrosis, among which pulmonary fibrosis poses a severe threat to patients' lives. In recent years, the application of novel therapeutic approaches (such as tumor immunotherapy and organ transplantation) and COVID-19 infections have further expanded the clinical demand for the diagnosis and treatment of pulmonary fibrosis. Currently, the two small-molecule drugs approved for idiopathic pulmonary fibrosis (IPF) (pirotinib and nintedanib) can only slow the decline in lung function and fail to improve patient mortality . Therefore, early diagnosis and early treatment of pulmonary fibrosis have become a clinical consensus , urgently requiring the emergence of innovative technologies and methods. Recent studies have demonstrated that collagen is not only a product of fibrosis but also a driving factor in its sustained progression . Therefore, identifying key molecular targets that promote collagen-driven fibrotic progression represents a critical direction for anti-fibrotic therapeutic research. Human collagen receptors identified include the discoidin domain receptor (DDR) family (including DDR1 and DDR2) and the integrin family (including α1β1, α2β1, α10β1, and α11β1). Extensive literature and preliminary research by various groups have established that DDR2 is the collagen receptor with the most significantly elevated expression level in the lung tissue of IPF patients. Unlike the "fast-on, fast-off" activation pattern of cytokine receptor tyrosine kinases (RTKs), the tyrosine phosphorylation of DDR1 and DDR2 requires the binding of large ligand molecules such as collagen for several hours before induction and can persist for dozens of hours, exhibiting a unique "slow-on, slow-off" pattern. This activation characteristic suggests that such molecular mechanisms may underlie the enduring biological effects mediated by DDRs in the progression of chronic fibrotic diseases.

Conditions

Interstitial Lung Disease

Keywords

PET; Interstitial lung disease; cognitive disorder; 68Ga-1A12

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)

DDR 2 PET

Targeted DDR2 Positron Emission Tomography Probe in the Biological Distribution of Lesions in Patients with Interstitial Lung Disease and Interstitial Lung Disease with Cognitive Impairment

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 with interstitial lung disease (ILD) or interstitial lung disease complicated by cognitive impairment

You may qualify if:

• No gender restriction, age ≥18 years (inclusive);
• Patients with interstitial lung disease who meet one of the following diagnoses: connective tissue disease-associated interstitial lung disease (CTD-ILD), idiopathic nonspecific interstitial pneumonia (iNSIP), chronic allergic pneumonia, sarcoidosis, environmental/occupational lung disease, or unclassifiable idiopathic interstitial disease (IIP);
• Screening subjects who were definitively diagnosed with interstitial lung disease (ILD) by high-resolution computed tomography (HRCT) within the preceding 6 months;
• In the first 3 months prior to screening, the carbon monoxide diffusion capacity (DLCO) (Hb-corrected) was within 30% to 80% (inclusive) of the predicted value; the forced vital capacity (FVC) was within 40% to 70% (inclusive) of the predicted value;
• The chief complaint is memory decline or other symptoms of cognitive impairment, with a disease course of ≥3 months;
• meets the diagnostic criteria for cognitive impairment caused by Alzheimer's disease (AD), mild cognitive impairment (MCI), or other related neurodegenerative diseases;
• The scores on the cognitive function screening scale meet the criteria for cognitive impairment (e.g., Mini-Mental State Examination (MMSE) \<24 points, or Montreal Cognitive Assessment (MoCA) \<26 points);

You may not qualify if:

• patients in critical condition requiring emergency care;
• Individuals with drug and/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, Army Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

histopathological findings obtained from biopsy or resected surgical specimens

MeSH Terms

Conditions

Lung Diseases, Interstitial; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

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: April 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)