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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 September 2023 |
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Main ID: |
NCT02723760 |
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Date of registration:
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10/03/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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99mTc-3PRGD2 SPECT/CT in Rheumatoid Arthritis Patients
TRGDRA |
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Scientific title:
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Clinical Study of 99mTc-3PRGD2 SPECT/CT in Diagnosis and Efficacy Evaluation of Rheumatoid Arthritis |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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4 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02723760 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Early Phase 1
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Countries of recruitment
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China
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Contacts
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Name:
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Weibing Miao, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: 99mTc-3PRGD2
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Primary Outcome(s)
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99mTc-3PRGD2 SPECT/CT scan
[Time Frame: Two year]
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Secondary Outcome(s)
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18F-FDG PET/CT
[Time Frame: One year]
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99mTc-MDP bone scan
[Time Frame: One year]
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Erythrocyte sedimentation rate (ESR)
[Time Frame: One year]
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Adverse events collection
[Time Frame: 5 days]
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Serum antinuclear antibodies (ANAs)
[Time Frame: One year]
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X-ray radiography and/or CT(computed tomograph) and/or MRI(magnetic resonance imaging)
[Time Frame: One year]
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Serum rheumatoid factor (RF)
[Time Frame: One year]
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Secondary ID(s)
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FAHFMUNM001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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