68Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid Arthritis (GRGDRA)
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|ClinicalTrials.gov Identifier: NCT01940926|
Recruitment Status : Unknown
Verified November 2014 by Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : September 12, 2013
Last Update Posted : April 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: 68Ga-BNOTA-PRGD2||Early Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic Performance and Evaluation Efficacy of 68Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid Arthritis|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||December 2017|
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.
Single dose intravenous injection of nearly 111 MBq 68Ga-BNOTA-PRGD2 at 30 minutes before PET/CT scanning
Other Name: 68Ga-p-SCN-Bn-NOTA-PEG3-RGD2
- 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.
- 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.
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): NCT01940926
|Contact: Zhaohui Zhu, MD, PhDfirstname.lastname@example.org|
|Contact: Kun Zheng, MDemail@example.com|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, China, 100730|
|Contact: Zhaohui Zhu, MD, PhD 86-10-69154196 firstname.lastname@example.org|
|Principal Investigator: Zhaohui Zhu, MD, PhD|
|Principal Investigator:||Zhaohui Zhu, MD, PhD||Peking Union Medical College Hospital|