68Ga-BNOTA-PRGD2 PET/CT in Diagnosis and Evaluation of Glioma (GRGDG)
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|ClinicalTrials.gov Identifier: NCT01801371|
Recruitment Status : Unknown
Verified April 2017 by Zhaohui Zhu, Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : February 28, 2013
Last Update Posted : April 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glioma||Drug: 68Ga-BNOTA-PRGD2||Early Phase 1|
Integrin αvβ3 is an important member of integrin receptor family and expressed preferentially on various types of tumor cells and the activated endothelial cells of tumor angiogenesis, but not or very low on the quiescent vessel cells and other normal cells. Therefore, the integrin αvβ3 receptor is becoming a valuable target for diagnosis and response evaluation of malignant tumors.
The tri-peptide sequence of arginine-glycine-aspartic acid (RGD) can specifically bind to the integrin αvβ3 receptor. Accordingly, a variety of radio-labeled RGD-based peptides have been developed for non-invasive imaging of integrin αvβ3 receptor expression via positron emission tomography (PET) or single photon emission computed tomography (SPECT). Among all RGD radiotracers, several PET imaging agents, including 18F-Galacto-RGD and 18F-AH111585, have been investigated in clinical trials for tumor diagnosis, and 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. Recently, serial 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, 68Ga-BNOTA-PRGD2 could be easily prepared and exhibited excellent in vivo behaviors in animal models. No adverse reactions have been observed in animal models to date.
For the further interests in clinical translation of 68Ga-BNOTA-PRGD2, an open-label brain PET/CT study was designed to investigate the diagnostic performance and evaluation efficacy of 68Ga-BNOTA-PRGD2 in pre-surgery glioma patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic Performance and Evaluation Efficacy of Brain 68Ga-BNOTA-PRGD2 PET/CT in Pre-surgery Glioma Patients|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
In patients in suspicion of glioma, single bolus of nearly 111 MBq 68Ga-BNOTA-PRGD2 will be intravenously injected 30 minutes before brain PET/CT to determine 68Ga-BNOTA-PRGD2 uptake in tumor and brain.
Single intravenous bolus injection of nearly 111 MBq 68Ga-BNOTA-PRGD2 at 30 minutes before brain PET/CT scanning.
Other Name: 68Ga-p-SCN-Bn-NOTA-PEG3-RGD2
- Semiquantitative measurement of standardized uptake values (SUVs) of lesions [ Time Frame: 1 year ]The semiquantitative analysis will be performed by the same person for all cases, and the standardized uptake value (SUV) of each tumor will be measured using a volume of interest (VOI) method.
- Number of participants with adverse events as a measure of safety [ Time Frame: 1 year ]Adverse events within 5 days after 68Ga-BNOTA-PRGD2 injection 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): NCT01801371
|Contact: Zhaohui Zhu, MDfirstname.lastname@example.org|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Zhaohui Zhu, MD 86-10-69154196 email@example.com|
|Contact: Xiaobin Zhao, MS 86-10-69155513 firstname.lastname@example.org|
|Principal Investigator: Zhaohui Zhu, MD|
|Principal Investigator:||Zhaohui Zhu, MD||Peking Union Medical College Hospital|