99mTc-3PRGD2 SPECT/CT in Rheumatoid Arthritis Patients (TRGDRA)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02723760|
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : March 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: 99mTc-3PRGD2||Early Phase 1|
As a critical member of adhesion molecule integrin family and an important representative angiogenesis-related molecular, integrin αvβ3 is expressed at low levels on mature endothelial cells and normal cells, but it is overexpressed on the neovasculature endothelial cells, which has a high specificity and affinity in binding to the tri-peptide sequence of arginine-glycine-aspartic acid (RGD). Angiogenesis in the synovial membrane plays an important role in the pathogenesis of rheumatoid arthritis (RA). Therefore, radiolabeled RGD peptides can be used as molecular probe in radionuclide imaging to assess angiogenesis noninvasively in vitro and investigate the progress of RA, so as to achieve the goal of early diagnosis and efficacy evaluation for RA.
Accordingly, a variety of radiolabeled RGD peptides have been used as radiotracers targeting the integrin αvβ3 expression to assess angiogenesis in vitro for noninvasive imaging via PET (positron emission tomography) or SPECT (single photon emission computed tomography). Some radiolabeled cyclic RGD peptides, such as 18F-Galacto-RGD, 18F-AH111585 and 99mTc-NC100692, have been investigated into clinical trials. The results demonstrated that both radiotracers allowed the specific imaging of various types of tumors, and the tumor uptake correlated well with the expression of integrin αvβ3 in both animal models and patients. Recently, several RGD dimeric peptides with PEG linkers have been studied. The new types of RGD peptides showed much higher in vitro integrin αvβ3-binding affinity than the single RGD tri-peptide sequence, and importantly, they exhibited significantly increased tumor uptake and improved in vivo kinetics in animal models. As a representative, 99mTc-3PRGD2 could be easily prepared and exhibited excellent in vivo behaviors in animal models. No adverse reactions are observed in animal models to date.
99mTc-3PRGD2, a novel tracer targeting integrin αvβ3 receptor, was tried to use in some tumors in recent years. However, there are few studies of 99mTc-3PRGD2 in other diseases except for tumors, especially no relevant reports in rheumatoid arthritis. Therefore, the investigators expect to further expand the applications of 99mTc-3PRGD2 in other diseases and to provide new methods and thoughts of assessing the efficacy of anti-αvβ3 or anti-angiogenesis therapy in rheumatoid arthritis. Based on the investigators previous animal study of 99mTc-3PRGD2 in RA, the investigators have strong interests in clinical trials of 99mTc-3PRGD2. An open-label SPECT/CT study has been designed to investigate 99mTc-3PRGD2 SPECT/CT in diagnosis and efficacy evaluation of RA. A single dose of nearly 11.1MBq/kg body weight 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of 99mTc-3PRGD2 SPECT/CT in Diagnosis and Efficacy Evaluation of Rheumatoid Arthritis|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||May 2020|
Experimental: 99mTc-3PRGD2 SPECT/CT scanning
Determine if 99mTc-3PRGD2 SPECT/CT is safe and effective in diagnosis and efficacy evaluation of rheumatoid arthritis
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).
Other Name: 99mTc-HYNIC-3PRGD2
- 99mTc-3PRGD2 SPECT/CT scan [ Time Frame: Two year ]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.
- X-ray radiography and/or CT(computed tomograph) and/or MRI(magnetic resonance imaging) [ Time Frame: One year ]X-ray radiography and/or CT and/or MRI will be carried out in RA patients to observe the degree of destruction for arthritic joints.
- 99mTc-MDP bone scan [ Time Frame: One year ]99mTc-MDP bone scan will be carried out in RA patients to observe the uptake of arthritic joints and to measure the SUVs of these joints.
- 18F-FDG PET/CT [ Time Frame: One year ]18F-FDG PET/CT will be carried out in RA patients to observe the uptake of arthritic joints and to measure the SUVs of these joints.
- Serum rheumatoid factor (RF) [ Time Frame: One year ]The patients will be required to test the serum rheumatoid factor routinely.
- Serum antinuclear antibodies (ANAs) [ Time Frame: One year ]The patients will be required to test the serum antinuclear antibodies routinely.
- Erythrocyte sedimentation rate (ESR) [ Time Frame: One year ]The patients will be required to test the blood erythrocyte sedimentation rate routinely.
- Adverse events collection [ Time Frame: 5 days ]Adverse events within 5 days after the injection and scanning of patients will be followed and assessed.
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): NCT02723760
|Contact: Chao Huang, MDfirstname.lastname@example.org|
|Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University||Recruiting|
|Fuzhou, Fujian, China, 350005|
|Contact: Weibing Miao, PhD +86-591-87981618 email@example.com|
|Contact: Chao Huang, MD +86-591-87981619 firstname.lastname@example.org|
|Principal Investigator: Weibing Miao, PhD|
|Sub-Investigator: Chao Huang, MD|
|Study Director:||Weibing Miao, PhD||Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University|