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

April 5, 2017 updated by: Peking Union Medical College Hospital

Diagnostic Performance and Evaluation Efficacy of 68Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid Arthritis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Zhaohui Zhu, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 68Ga-p-SCN-Bn-NOTA-PEG3-RGD2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Zhaohui Zhu, MD, PhD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 9, 2013

First Posted (Estimate)

September 12, 2013

Study Record Updates

Last Update Posted (Actual)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCHNM07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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