Ignite Creation Date:
2024-05-06 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01801371
Status:
UNKNOWN
Last Update Posted:
2017-04-07
First Post:
2013-02-22
Brief Title:
68Ga-BNOTA-PRGD2 PETCT in Diagnosis and Evaluation of Glioma
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
Diagnostic Performance and Evaluation Efficacy of Brain 68Ga-BNOTA-PRGD2 PETCT in Pre-surgery Glioma Patients
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GRGDG
Brief Summary:
This is an open-label brain PETCT positron emission tomographycomputed tomography study to investigate the diagnostic performance and evaluation efficacy of 68Ga-BNOTA-PRGD2 in glioma patients A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 40 µg BNOTA-PRGD2 will be intravenously injected into patients in suspicion of glioma Visual and semiquantitative method will be used to assess the PETCT images Brain MRI withwithout enhancement and 18F-FDG PETCT will be performed for comparison The postoperative pathology and integrin αvβ3 and CD34 immunohistochemical stains will also be used for correlation
Detailed Description:
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 PETCT study was designed to investigate the diagnostic performance and evaluation efficacy of 68Ga-BNOTA-PRGD2 in pre-surgery glioma patients
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 PETCT study was designed to investigate the diagnostic performance and evaluation efficacy of 68Ga-BNOTA-PRGD2 in pre-surgery glioma patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None