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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
Sponsor:
Collaborator:
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Zhaohui Zhu, Peking Union Medical College Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Glioma Drug: 68Ga-BNOTA-PRGD2 Early Phase 1

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 68Ga-BNOTA-PRGD2
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.
Drug: 68Ga-BNOTA-PRGD2
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Zhaohui Zhu, MD 86-10-69154196 zzh_1969@yahoo.com.cn

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Zhaohui Zhu, MD    86-10-69154196    zhuzhh@pumch.cn   
Contact: Xiaobin Zhao, MS    86-10-69155513    flxzxb@163.com   
Principal Investigator: Zhaohui Zhu, MD         
Sponsors and Collaborators
Peking Union Medical College Hospital
Beijing Tiantan Hospital
Investigators
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Principal Investigator: Zhaohui Zhu, MD Peking Union Medical College Hospital

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Responsible Party: Zhaohui Zhu, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01801371     History of Changes
Other Study ID Numbers: PUMCHNM6
First Posted: February 28, 2013    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zhaohui Zhu, Peking Union Medical College Hospital:
Glioma
Diagnostic imaging
Integrin receptor
68Ga-BNOTA-PRGD2
PET/CT

Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue