68Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid Arthritis
- Registration Number
- NCT01940926
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief 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.
- Detailed Description
The Alpha(v)beta3 integrin, one of the most prominent members of integrin superfamily, is trans-membrane heterodimeric proteins which mediate cell-cell and cell-extracellular matrix adhesion. Integrin alpha(v)beta3 receptor plays an pivotal role in promoting, sustaining and regulating the angiogenesis and was identified as a marker of angiogenic vascular tissue. Cyclic arginine-glycine-aspartic acid (RGD) peptides was identified as a key integrin recognition motif which could strongly bind to integrin alpha(v)beta3 and inhibit new blood vessel formation. Animal study in antigen induced arthritis demonstrated that intra-articular administration of a cyclic RGD antagonist of alpha(v)beta3 leading to inhibition of cell infiltrate, synovial angiogenesis, pannus formation, cartilage erosions and even diminishing arthritis severity. For these properties, RGD peptide-based multimodality molecular probes have been developed for noninvasive imaging by targeting integrin alpha(v)beta3. And compared with 18F-FDG PET/CT, radiolabeled RGD imaging is a promising approach to visualize angiogenesis and provide a therapeutic target for anti-angiogenetic and anti-integrin therapy.
For the further interests in clinical translation of 68Ga-BNOTA-PRGD2, an open-label PET/CT study was designed to investigate the diagnostic performance and evaluation efficacy of 68Ga-BNOTA-PRGD2 in RA patients.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Patients fulfilled the 1987 revised criteria of the American College of Rheumatology (ACR) for RA;
- Males and females, ≥18 years old
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 68Ga-BNOTA-PRGD2 68Ga-BNOTA-PRGD2 In patients with RA, single dose intravenous injection of nearly 111 MBq 68Ga-BNOTA-PRGD2 will be given at 30 minutes before PET/CT scanning to determine 68Ga-BNOTA-PRGD2 uptake in joints.
- Primary Outcome Measures
Name Time Method Semiquantitative assessment (Standardized Uptake Values = SUVs) of lesion 1 year The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake values (SUVs) of 68Ga-BNOTA-PRGD2 will be measured using a volume-of-interest method.
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events as a measure of safety 1 year Adverse events within 5 days after intravenous injection of 68Ga-BNOTA-PRGD2 and PET/CT scanning will be collected and analyzed.
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, China