Analyse of Inflammatory Activity of Sjögren's Syndrome on 68Ga-FAPI PET-CT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Sjögren's syndrome (SS) is a chronic autoimmune disease primarily affecting the salivary and lacrimal glands, leading to symptoms of dryness. Assessing the inflammatory activity is crucial for guiding treatment. Fibroblast activation protein (FAPI) PET is an emerging imaging technique increasingly used for evaluating various inflammations and tumors. Thus this prospective study is going to investigate the uptake characteristics of FAPI PET in Sjögren's syndrome and evaluate its potential in assessing inflammatory activity to guide clinical treatment. A control group of tumor patients undergoing FAPI PET imaging will be included to compare FAPI uptake patterns between autoimmune inflammation and neoplasia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pelvic Floor and Sexual Dysfunction in Women with Sjogren's Syndrome

NCT04415710

Sexual Dysfunction Pelvic Floor Disorders Pelvic Organ Prolapse +2 more

COMPLETED

Involvement of Immune Cells Derived From the Intestine in Sjogren's Syndrome

NCT03841318

Sjogren's Syndrome

COMPLETED NA

Descriptive Study of Variations in Serum Translocation Markers of the Intestinal Microbiota in Patients With Gougerot-Sjögren Syndrome According to Disease Activity

NCT04462601

Sjogren's Syndrome

ACTIVE_NOT_RECRUITING

Prospective Studies on Immunopathogenesis of Liver Fibrosis

NCT04943978

Chronic Liver Disease

RECRUITING

Cytokines and the Risk of Infection in Liver Cirrhosis

NCT00857181

Liver Cirrhosis

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Sjögren's syndrome (SS), characterized by its chronic autoimmune nature, predominantly targets the salivary and lacrimal glands, resulting in the classic symptoms of dry mouth and dry eyes. This condition can extend beyond these glands, impacting other systems in the body and leading to a variety of clinical manifestations, such as fatigue, joint pain, and in more severe cases, an increased risk of lymphoma. The heterogeneity of SS, with its potential to affect multiple organs, underscores the importance of accurately assessing the level of inflammation when developing a treatment plan.

Fibroblast activation protein (FAPI) PET imaging is a cutting-edge diagnostic tool that has shown promise in the detection and evaluation of inflammation associated with a range of pathologies, including various tumors. This innovative imaging technique takes advantage of the elevated levels of FAPI, a protein that is overexpressed in cancer-associated fibroblasts, which are a common feature in numerous malignant solid tumors. Moreover, FAPI's role in inflammation suggests its potential as a biomarker for disease activity in conditions like SS.

The prospective study mentioned aims to delve deeper into the utility of FAPI PET in the context of SS. It will explore how FAPI PET imaging can be applied to visualize and quantify inflammatory changes within the salivary and lacrimal glands, which are typically affected in SS. The study will involve a cohort of SS patients who will undergo FAPI PET scans, and the findings will be correlated with their clinical symptoms, serological markers of inflammation, and other imaging modalities.

The primary objective of this study is to determine the uptake characteristics of FAPI PET in patients with SS, providing valuable data on the distribution and intensity of FAPI uptake in affected tissues. By analyzing these patterns, researchers can assess whether FAPI PET imaging can serve as a reliable and sensitive biomarker for inflammatory activity in SS. This information could be instrumental in guiding clinical treatment decisions, predicting treatment responses, and identifying potential disease flares.

If the study confirms the effectiveness of FAPI PET in assessing inflammation in SS, it could revolutionize the way the disease is monitored and managed. The ability to non-invasively visualize and quantify inflammation could lead to more personalized treatment strategies, more precise disease monitoring, and ultimately, improved outcomes for individuals living with SS. Furthermore, this research could also open up new avenues for understanding the pathophysiology of SS and other autoimmune conditions, potentially leading to the development of novel therapeutic targets and approaches.

The study will also include a control group of patients with various tumors who are scheduled for 68Ga-FAPI PET/CT as part of their diagnostic workup. This will allow for a comparative analysis of FAPI uptake between inflammatory and malignant lesions, enhancing the specificity assessment of FAPI PET in autoimmune disease.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sjogren's Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

68Ga-FAPI PET/CT in Sjögren's Syndrome

All patients diagnosed with Sjögren's syndrome underwent 68Ga-FAPI PET/CT.

Group Type EXPERIMENTAL

68Ga-FAPI

Intervention Type DRUG

Intravenous injection of one dosage of 18.5-22.2MBq (0.5-0.6 mCi)/Kg 68Ga-FAPI. Tracer doses of 68Ga- FAPI will be used to image lesions of Sjögren's syndrome by PET/ CT.

68Ga-FAPI PET/CT in tumor patients

Patients with tumors such as lung cancer and breast cancer, who had been excluded for Sjögren's syndrome, underwent 68Ga-FAPI PET/CT.

Group Type EXPERIMENTAL

68Ga-FAPI

Intervention Type DRUG

Intravenous injection of one dosage of 18.5-22.2MBq (0.5-0.6 mCi)/Kg 68Ga-FAPI. Tracer doses of 68Ga- FAPI will be used to image lesions of Sjögren's syndrome by PET/ CT.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

68Ga-FAPI

Intravenous injection of one dosage of 18.5-22.2MBq (0.5-0.6 mCi)/Kg 68Ga-FAPI. Tracer doses of 68Ga- FAPI will be used to image lesions of Sjögren's syndrome by PET/ CT.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

68Ga-Fibroblast activation protein Inhibitor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18-80 years;
* Fulfillment of the 2016 ACR-EULAR Classification Criteria for pSS at enrollment. OR diagnosis of a solid tumor scheduled for FAPI PET imaging

Exclusion Criteria

* Combined with tumors or other connective tissue diseases (for SS group);
* Patients who are currently using hormones/biological agents (for both groups)；
* Pregnancy or lactation

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes