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

NCT02723760 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2023-09-21

No results posted yet for this study

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

Interventions

DRUG

99mTc-3PRGD2

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).

Sponsors & Collaborators

  • First Affiliated Hospital of Fujian Medical University

    lead OTHER

Principal Investigators

  • Weibing Miao, PhD · Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02723760 on ClinicalTrials.gov