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

Phase 0
18 Years
Open (Enrolling)

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Semiquantitative measurement of standardized uptake values (SUVs) of lesions

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Zhaohui Zhu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking Union Medical College Hospital


China: Ministry of Health

Study ID:




Start Date:

October 2012

Completion Date:

December 2014

Related Keywords:

  • Glioma
  • Glioma
  • Diagnostic imaging
  • Integrin receptor
  • 68Ga-BNOTA-PRGD2
  • PET/CT
  • Glioma