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Characterizing Spondyloarthritis With 68Ga-FAPI PET/CT

Primary Purpose

Spondyloarthritis, Axial Spondyloarthritis, Ankylosing Spondylitis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drug: 68Ga-FAPI
Sponsored by
The First Affiliated Hospital of Xiamen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spondyloarthritis focused on measuring Spondyloarthritis, Axial Spondyloarthritis, Ankylosing Spondylitis, 68Ga-FAPI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A diagnosis of SpA according to the ASAS (Assessment of Spondyloarthritis International Society) classification criteria for SpA. Adult men or women 18 and ≤ 65 years of age at the time of signing the informed consent (ICF). participants who were able to provide informed consent (signed by participant or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee. Exclusion Criteria: Pregnancy; Breastfeeding; known allergy against FAPI; any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Sites / Locations

  • The first affiliated hospital of Xiamen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inject 68Ga-FAPI and then perform PET/CT scan.

Arm Description

Inject 68Ga-FAPI and then perform PET/CT scan

Outcomes

Primary Outcome Measures

To define the distribution pattern of 68Ga-FAPI in SpA patients.
To quantify 68Ga-FAPI tracer biodistribution in characteristic inflammatory tissue including SI joints, spine, and the peripheral joints versus conventional x ray examination or magnetic resonance imaging (MRI) techniques in adult active SpA. 68Ga-FAPI PET tracer biodistribution will be assessed by semi-quantitative analysis (unit/metrics = standardized uptake values (SUV)).

Secondary Outcome Measures

Correlation between uptake of 68GA-FAPI and other parameters associated with disease activity.
Correlation between uptake of 68GA-FAPI and parameters associated with disease activity including Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath ankylosing spondylitis disease activity index (BSADAI), Bath ankylosing spondylitis functional index (BASFI),and Maastricht Ankylosing Spondylitis Enthesitis Score(MASES). The Standardized uptake value (SUV) of 68Ga-FAPI was calculated and analyzing the correlation between pathological results and parameters associated with disease activity.
Correlation between uptake of 68GA-FAPI change and disease activity change
Correlation between change in standardized uptake value (SUV) of 68Ga-FAPI at inflammatory site with change in Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath ankylosing spondylitis disease activity index (BSADAI), Bath ankylosing spondylitis functional index (BASFI),and Maastricht Ankylosing Spondylitis Enthesitis Score(MASES) at different disease stage.
Correlation between uptake of 68GA-FAPI and therapy response
Percentage of participants achieving ankylosing spondylitis disease activity score inactive disease [ASDAS ID (<1.3)] after 1 year standardized treatment in participants with high standardized uptake value (SUV) of 68Ga-FAPI and low standardized uptake value (SUV) of 68Ga-FAPI at baseline.

Full Information

First Posted
July 30, 2023
Last Updated
August 13, 2023
Sponsor
The First Affiliated Hospital of Xiamen University
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1. Study Identification

Unique Protocol Identification Number
NCT05999643
Brief Title
Characterizing Spondyloarthritis With 68Ga-FAPI PET/CT
Official Title
Characterizing Spondyloarthritis With 68Ga-FAPI PET/CT
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Xiamen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To evaluate the potential usefulness of 68Ga-FAPI PET/CT for the diagnosis, inflammation evaluation and prognosis prediction in spondyloarthritis.
Detailed Description
Spondyloarthritis (SpA) is a chronic inflammatory rheumatic disease characterized by inflammatory back pain, enthesitis, dactylitis, and the formation of syndesmophytes, all of which significantly affect a patient's healthy functioning and general quality of life. Prevalence of underlying malignancy is high in patients with SpA. Radiographic sacroiliitis became a crucial finding in the diagnosis and classification of patients. 68Ga-FAPI has been developed as tracers specific for fibroblast-activation protein (FAP), which is overexpressed in activated fibroblasts in various type of cancers and autoimmune diseases, such as rheumatoid arthritis, IgG4-related diseases and interstitial lung diseases. Recently the investigators have published articles of the application of 68Ga-FAPI in IgG4-related disease and rheumatoid arthritis, which showed it was more sensitive than FDG in detecting a certain type of inflammation. Increased 68Ga-FAPI Uptake in ankylosing spondylitis in a patient with rectal cancer has also been reported in a case report, indicating the potential utility of FAP-targeted PET/CT imaging for diagnosis and disease assessment in spondyloarthritis. Thus, this prospective study is going to investigate utility of 68Ga-FAPI PET/CT in diagnosis of spondyloarthritis as well as inflammation assessment in joints including the sacroiliac (SI) joints, spine and peripheral joints. Also, this study aims to investigate potential utility of 68Ga-FAPI PET/CT in predicting treatment response and disease prognosis such as formation of syndesmophytes and erosive changes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthritis, Axial Spondyloarthritis, Ankylosing Spondylitis
Keywords
Spondyloarthritis, Axial Spondyloarthritis, Ankylosing Spondylitis, 68Ga-FAPI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inject 68Ga-FAPI and then perform PET/CT scan.
Arm Type
Experimental
Arm Description
Inject 68Ga-FAPI and then perform PET/CT scan
Intervention Type
Diagnostic Test
Intervention Name(s)
Drug: 68Ga-FAPI
Other Intervention Name(s)
68Ga-fibroblast activating protein inhibitors
Intervention Description
Intravenous injection of one dosage of 111-185 MBq (3-5 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image SpA lesions in SI joints, spine, musculoskeletal and the extra-articular involvement by PET/CT.
Primary Outcome Measure Information:
Title
To define the distribution pattern of 68Ga-FAPI in SpA patients.
Description
To quantify 68Ga-FAPI tracer biodistribution in characteristic inflammatory tissue including SI joints, spine, and the peripheral joints versus conventional x ray examination or magnetic resonance imaging (MRI) techniques in adult active SpA. 68Ga-FAPI PET tracer biodistribution will be assessed by semi-quantitative analysis (unit/metrics = standardized uptake values (SUV)).
Time Frame
60 minutes following injection
Secondary Outcome Measure Information:
Title
Correlation between uptake of 68GA-FAPI and other parameters associated with disease activity.
Description
Correlation between uptake of 68GA-FAPI and parameters associated with disease activity including Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath ankylosing spondylitis disease activity index (BSADAI), Bath ankylosing spondylitis functional index (BASFI),and Maastricht Ankylosing Spondylitis Enthesitis Score(MASES). The Standardized uptake value (SUV) of 68Ga-FAPI was calculated and analyzing the correlation between pathological results and parameters associated with disease activity.
Time Frame
30 days
Title
Correlation between uptake of 68GA-FAPI change and disease activity change
Description
Correlation between change in standardized uptake value (SUV) of 68Ga-FAPI at inflammatory site with change in Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath ankylosing spondylitis disease activity index (BSADAI), Bath ankylosing spondylitis functional index (BASFI),and Maastricht Ankylosing Spondylitis Enthesitis Score(MASES) at different disease stage.
Time Frame
Up to 2 years
Title
Correlation between uptake of 68GA-FAPI and therapy response
Description
Percentage of participants achieving ankylosing spondylitis disease activity score inactive disease [ASDAS ID (<1.3)] after 1 year standardized treatment in participants with high standardized uptake value (SUV) of 68Ga-FAPI and low standardized uptake value (SUV) of 68Ga-FAPI at baseline.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A diagnosis of SpA according to the ASAS (Assessment of Spondyloarthritis International Society) classification criteria for SpA. Adult men or women 18 and ≤ 65 years of age at the time of signing the informed consent (ICF). participants who were able to provide informed consent (signed by participant or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee. Exclusion Criteria: Pregnancy; Breastfeeding; known allergy against FAPI; any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Liu, MD
Phone
86 0592-2137749
Email
iuyuan@xmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Haojun Chen, PhD
Phone
86 0592-2137166
Email
leochen0821@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guixiu Shi, PhD
Organizational Affiliation
The First Affiliated Hospital of Xiamen University
Official's Role
Study Director
Facility Information:
Facility Name
The first affiliated hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiuwan Wu, PhD
Phone
86 0592-2137507
First Name & Middle Initial & Last Name & Degree
Yuan Liu, MD
First Name & Middle Initial & Last Name & Degree
Haojun Chen, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Characterizing Spondyloarthritis With 68Ga-FAPI PET/CT

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