NCT01940926

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1 rheumatoid-arthritis

Timeline
Completed

Started Feb 2012

Longer than P75 for early_phase_1 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 7, 2017

Status Verified

November 1, 2014

Enrollment Period

5.8 years

First QC Date

September 9, 2013

Last Update Submit

April 5, 2017

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritisangiogenesis68Ga-PRGD218F-FDGpositron emission tomography/computed tomography

Outcome Measures

Primary Outcomes (1)

  • Semiquantitative assessment (Standardized Uptake Values = SUVs) of lesion

    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 Outcomes (1)

  • Number of participants with adverse events as a measure of safety

    1 year

Study Arms (1)

68Ga-BNOTA-PRGD2

EXPERIMENTAL

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

Interventions

68Ga-BNOTA-PRGD2DRUG

Single dose intravenous injection of nearly 111 MBq 68Ga-BNOTA-PRGD2 at 30 minutes before PET/CT scanning

Also known as: 68Ga-p-SCN-Bn-NOTA-PEG3-RGD2
68Ga-BNOTA-PRGD2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients fulfilled the 1987 revised criteria of the American College of Rheumatology (ACR) for RA;
  • Males and females, ≥18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

Related Publications (1)

  • Zhu Z, Yin Y, Zheng K, Li F, Chen X, Zhang F, Zhang X. Evaluation of synovial angiogenesis in patients with rheumatoid arthritis using (6)(8)Ga-PRGD2 PET/CT: a prospective proof-of-concept cohort study. Ann Rheum Dis. 2014 Jun;73(6):1269-72. doi: 10.1136/annrheumdis-2013-204820. Epub 2014 Feb 14.

    PMID: 24532680DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

68gallium-BNOTA-PRGD2

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Zhaohui Zhu, MD, PhD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaohui Zhu, MD, PhD

CONTACT

86-10-69154196zhuzhh@pumch.cn

Kun Zheng, MD

CONTACT

86-10-69155513aqua.zhk@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 12, 2013

Study Start

February 1, 2012

Primary Completion

November 1, 2017

Study Completion

December 1, 2017

Last Updated

April 7, 2017

Record last verified: 2014-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)