Rheumatoid Arthritis Clinical Trial
— TRGDRAOfficial title:
Clinical Study of 99mTc-3PRGD2 SPECT/CT in Diagnosis and Efficacy Evaluation of Rheumatoid Arthritis
Verified date | September 2023 |
Source | First Affiliated Hospital of Fujian Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an open-label SPECT/CT (single photon emission computed tomography/computed tomography) study to investigate the diagnosis and efficacy evaluation performance of 99mTc-3PRGD2 in rheumatoid arthritis patients. A single dose of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 (≤20µg 3PRGD2) will be intravenously injected into the patients. Visual and semiquantitative method will be used to assess the whole-body planar and lesions section SPECT/CT images. Adverse events will also be observed in the patients.
Status | Completed |
Enrollment | 4 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility | Inclusion Criteria: - Diagnostic group: - Males and females, =20 and = 70 years old. - X-ray radiography and/or CT and/or MRI and/or 99mTc-MDP bone scan and/or 18F-FDG PET/CT diagnosis in suspicion of primary or recurrent rheumatoid arthritis (RA). - The above patients should be confirmed according to the ACR/EULAR (American rheumatism association and the European Union for resistance rheumatism) diagnostic criteria of RA. - Efficacy evaluation group: - Males and females, =20 and = 70 years old. - Firstly and definitely diagnose with RA, and prepare to treat. - X-ray radiography and/or CT and/or MRI and/or 99mTc-MDP bone scan and/or 18F-FDG PET/CT before treatment, the midterm treatment and late stage treatment (three months after the initial treatment) are available. Exclusion Criteria: - Females planning to bear a child recently or with childbearing potential. - Known severe allergy or hypersensitivity to IV radiographic contrast. - Inability to lie still for the entire imaging time because of cough, pain, etc. - Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc. - Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance. |
Country | Name | City | State |
---|---|---|---|
China | Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Fujian Medical University |
China,
Huang C, Zheng Q, Miao W. Study of novel molecular probe 99mTc-3PRGD2 in the diagnosis of rheumatoid arthritis. Nucl Med Commun. 2015 Dec;36(12):1208-14. doi: 10.1097/MNM.0000000000000375. — View Citation
Miao W, Zheng S, Dai H, Wang F, Jin X, Zhu Z, Jia B. Comparison of 99mTc-3PRGD2 integrin receptor imaging with 99mTc-MDP bone scan in diagnosis of bone metastasis in patients with lung cancer: a multicenter study. PLoS One. 2014 Oct 22;9(10):e111221. doi: 10.1371/journal.pone.0111221. eCollection 2014. — View Citation
Zhu Z, Miao W, Li Q, Dai H, Ma Q, Wang F, Yang A, Jia B, Jing X, Liu S, Shi J, Liu Z, Zhao Z, Wang F, Li F. 99mTc-3PRGD2 for integrin receptor imaging of lung cancer: a multicenter study. J Nucl Med. 2012 May;53(5):716-22. doi: 10.2967/jnumed.111.098988. Epub 2012 Apr 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 99mTc-3PRGD2 SPECT/CT scan | 99mTc-3PRGD2 SPECT/CT scan will be carried out in RA patients to implement visual and semiquantitative assessment of arthritic joints. Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician to observe the the uptake of 99mTc-3PRGD2 on arthritic joints. The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake values (SUVs) of arthritic joints and organs will be measured. | Two year | |
Secondary | X-ray radiography and/or CT(computed tomograph) and/or MRI(magnetic resonance imaging) | X-ray radiography and/or CT and/or MRI will be carried out in RA patients to observe the degree of destruction for arthritic joints. | One year | |
Secondary | 99mTc-MDP bone scan | 99mTc-MDP bone scan will be carried out in RA patients to observe the uptake of arthritic joints and to measure the SUVs of these joints. | One year | |
Secondary | 18F-FDG PET/CT | 18F-FDG PET/CT will be carried out in RA patients to observe the uptake of arthritic joints and to measure the SUVs of these joints. | One year | |
Secondary | Serum rheumatoid factor (RF) | The patients will be required to test the serum rheumatoid factor routinely. | One year | |
Secondary | Serum antinuclear antibodies (ANAs) | The patients will be required to test the serum antinuclear antibodies routinely. | One year | |
Secondary | Erythrocyte sedimentation rate (ESR) | The patients will be required to test the blood erythrocyte sedimentation rate routinely. | One year | |
Secondary | Adverse events collection | Adverse events within 5 days after the injection and scanning of patients will be followed and assessed. | 5 days |
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