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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01940926
Recruitment Status : Unknown
Verified November 2014 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2013
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: 68Ga-BNOTA-PRGD2 Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic Performance and Evaluation Efficacy of 68Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid Arthritis
Study Start Date : February 2012
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: 68Ga-BNOTA-PRGD2
Single dose intravenous injection of nearly 111 MBq 68Ga-BNOTA-PRGD2 at 30 minutes before PET/CT scanning
Other Name: 68Ga-p-SCN-Bn-NOTA-PEG3-RGD2




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of participants with adverse events as a measure of safety [ Time Frame: 1 year ]
    Adverse events within 5 days after intravenous injection of 68Ga-BNOTA-PRGD2 and PET/CT scanning will be collected and analyzed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940926


Contacts
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Contact: Zhaohui Zhu, MD, PhD 86-10-69154196 zhuzhh@pumch.cn
Contact: Kun Zheng, MD 86-10-69155513 aqua.zhk@gmail.com

Locations
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China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Zhaohui Zhu, MD, PhD    86-10-69154196    zhuzhh@pumch.cn   
Principal Investigator: Zhaohui Zhu, MD, PhD         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Zhaohui Zhu, MD, PhD Peking Union Medical College Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01940926    
Other Study ID Numbers: PUMCHNM07
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: November 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Peking Union Medical College Hospital:
rheumatoid arthritis
angiogenesis
68Ga-PRGD2
18F-FDG
positron emission tomography/computed tomography
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases