68Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid Arthritis

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label positron emission tomography/computed tomography ( PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-BNOTA-PRGD2 in rheumatoid arthritis (RA) patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 (≤ 40 µg BNOTA-PRGD2) will be intravenously injected into patients with RA. Visual and semiquantitative method will be used to assess the PET/CT images. Whole body 18F-FDG PET/CT will be performed for comparison.

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

Details

• Lead Sponsor: Peking Union Medical College Hospital

Criteria

Inclusion Criteria:

• Patients fulfilled the 1987 revised criteria of the American College of Rheumatology (ACR) for RA;

• Males and females, ≥18 years old

Exclusion Criteria:

• Concurrent medical conditions of other autoimmune diseases

• Latent or active joint infection or joint injury

• Renal dysfunction (serum level of creatinine more than 1.2 mg/dL)

• Females planning to bear a child recently or with childbearing potential

• Known severe allergy or hypersensitivity to intravenous 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