99mTc-3PRGD2 SPECT/CT in Rheumatoid Arthritis Patients

NCT02723760 | Completed Early Phase 1 DMC

• 1 other identifier: FAHFMUNM001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label SPECT/CT (single photon emission computed tomography/computed tomography) study to investigate the diagnosis and efficacy evaluation performance of 99mTc-3PRGD2 in rheumatoid arthritis patients. A single dose of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 (≤20µg 3PRGD2) will be intravenously injected into the patients. Visual and semiquantitative method will be used to assess the whole-body planar and lesions section SPECT/CT images. Adverse events will also be observed in the patients.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 99mTc-3PRGD2 SPECT/CT scan

  99mTc-3PRGD2 SPECT/CT scan will be carried out in RA patients to implement visual and semiquantitative assessment of arthritic joints. Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician to observe the the uptake of 99mTc-3PRGD2 on arthritic joints. The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake values (SUVs) of arthritic joints and organs will be measured.

  Two year

Secondary Outcomes (7)

• X-ray radiography and/or CT(computed tomograph) and/or MRI(magnetic resonance imaging)

  One year

• 99mTc-MDP bone scan

  One year

• 18F-FDG PET/CT

  One year

• Serum rheumatoid factor (RF)

  One year

• Serum antinuclear antibodies (ANAs)

  One year

Study Arms (1)

99mTc-3PRGD2 SPECT/CT scanning

EXPERIMENTAL

Determine if 99mTc-3PRGD2 SPECT/CT is safe and effective in diagnosis and efficacy evaluation of rheumatoid arthritis

Drug: 99mTc-3PRGD2

Interventions

99mTc-3PRGD2 DRUG

SPECT/CT scanning: single intravenous bolus injection of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 on rheumatoid arthritis patients, whole-body planar and lesions section for determination the accumulation of 99mTc-3PRGD2 in the joints and other parts of the body. For diagnosis study, each patient will be carried out SPECT/CT scanning once. For efficacy evaluation study, each patient will be carried out SPECT/CT scanning three times (before treatment, the midterm treatment and late stage treatment).

Also known as: 99mTc-HYNIC-3PRGD2

99mTc-3PRGD2 SPECT/CT scanning

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnostic group:
• Males and females, ≥20 and ≤ 70 years old.
• X-ray radiography and/or CT and/or MRI and/or 99mTc-MDP bone scan and/or 18F-FDG PET/CT diagnosis in suspicion of primary or recurrent rheumatoid arthritis (RA).
• The above patients should be confirmed according to the ACR/EULAR (American rheumatism association and the European Union for resistance rheumatism) diagnostic criteria of RA.
• Efficacy evaluation group:
• Males and females, ≥20 and ≤ 70 years old.
• Firstly and definitely diagnose with RA, and prepare to treat.
• X-ray radiography and/or CT and/or MRI and/or 99mTc-MDP bone scan and/or 18F-FDG PET/CT before treatment, the midterm treatment and late stage treatment (three months after the initial treatment) are available.

You may not qualify if:

• Females planning to bear a child recently or with childbearing potential.
• Known severe allergy or hypersensitivity to IV 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.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

Related Publications (3)

• Zhu Z, Miao W, Li Q, Dai H, Ma Q, Wang F, Yang A, Jia B, Jing X, Liu S, Shi J, Liu Z, Zhao Z, Wang F, Li F. 99mTc-3PRGD2 for integrin receptor imaging of lung cancer: a multicenter study. J Nucl Med. 2012 May;53(5):716-22. doi: 10.2967/jnumed.111.098988. Epub 2012 Apr 12.

  PMID: 22499615 BACKGROUND

• Miao W, Zheng S, Dai H, Wang F, Jin X, Zhu Z, Jia B. Comparison of 99mTc-3PRGD2 integrin receptor imaging with 99mTc-MDP bone scan in diagnosis of bone metastasis in patients with lung cancer: a multicenter study. PLoS One. 2014 Oct 22;9(10):e111221. doi: 10.1371/journal.pone.0111221. eCollection 2014.

  PMID: 25338281 BACKGROUND

• Huang C, Zheng Q, Miao W. Study of novel molecular probe 99mTc-3PRGD2 in the diagnosis of rheumatoid arthritis. Nucl Med Commun. 2015 Dec;36(12):1208-14. doi: 10.1097/MNM.0000000000000375.

  PMID: 26352213 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Weibing Miao, PhD

  Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Nuclear Medicine

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 30, 2016
• Study Start: November 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)