99mTc-3PRGD2 SPECT/CT in Rheumatoid Arthritis Patients

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Fujian Medical University
• Treatments: HYNIC-3PRGD(2)

Criteria

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.