68Ga-BNOTA-PRGD2 PET/CT in Diagnosis and Evaluation of Glioma

Glioma Clinical Trial

— GRGDG  

Official title:

Diagnostic Performance and Evaluation Efficacy of Brain 68Ga-BNOTA-PRGD2 PET/CT in Pre-surgery Glioma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01801371
• Other study ID #: PUMCHNM6
• Status: Recruiting
• Phase: Early Phase 1
• First received: February 22, 2013
• Last updated: April 5, 2017
• Start date: October 2012
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: Peking Union Medical College Hospital
• Contact: Zhaohui Zhu, MD
• Phone: 86-10-69154196
• Email: zzh_1969[@]yahoo.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label brain PET/CT (positron emission tomography/computed 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 PET/CT images. Brain MRI with/without enhancement and 18F-FDG PET/CT will be performed for comparison. The postoperative pathology and integrin αvβ3 and CD34 immunohistochemical stains will also be used for correlation.

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 PET/CT study was designed to investigate the diagnostic performance and evaluation efficacy of 68Ga-BNOTA-PRGD2 in pre-surgery glioma patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and females, =18 years old;

• In suspicion of brain glioma on MRI;

• The tumor will be surgically removed and histological diagnosis will be available.

Exclusion Criteria:

• Females planning to bear a child recently or with childbearing potential;

• Known severe allergy or hypersensitivity to IV radiographic contrast;

• Inability to lie still for the entire imaging time because of cough, pain, etc.

• Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.

• Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.

Related Conditions & MeSH terms

• Glioma

Intervention

Drug:
• 68Ga-BNOTA-PRGD2
Single intravenous bolus injection of nearly 111 MBq 68Ga-BNOTA-PRGD2 at 30 minutes before brain PET/CT scanning.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Semiquantitative measurement of standardized uptake values (SUVs) of lesions	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.	1 year
Secondary	Number of participants with adverse events as a measure of safety	Adverse events within 5 days after 68Ga-BNOTA-PRGD2 injection and PET/CT scanning will be collected and analyzed.	1 year