Rheumatoid Arthritis
Conditions
Keywords
rheumatoid arthritis, angiogenesis, 68Ga-PRGD2, 18F-FDG, positron emission tomography/computed tomography
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.
Interventions
DRUG68Ga-BNOTA-PRGD2
Single dose intravenous injection of nearly 111 MBq 68Ga-BNOTA-PRGD2 at 30 minutes before PET/CT scanning
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactZhaohui Zhu, MD, PhD
Backup ContactKun Zheng, MD
Outcome results
None listed