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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Early Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: 68Ga-BNOTA-PRGD2

Study type: Interventional

Funder types: Other

Identifiers

NCT01940926

PUMCHNM07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

68Ga-BNOTA-PRGD2

Experimental group

Description:

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.

Treatment:

Drug: 68Ga-BNOTA-PRGD2