Diagnostic Performance and Evaluation Efficacy of 68Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid Arthritis
Overview
- Phase
- Early Phase 1
- Intervention
- 68Ga-BNOTA-PRGD2
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Peking Union Medical College Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Semiquantitative assessment (Standardized Uptake Values = SUVs) of lesion
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
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.
Intervention: 68Ga-BNOTA-PRGD2
Outcomes
Primary Outcomes
Semiquantitative assessment (Standardized Uptake Values = SUVs) of lesion
Time Frame: 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 Outcomes
- Number of participants with adverse events as a measure of safety(1 year)