Safety and Diagnostic Performance of 99mTc-3PRGD2 SPECT/CT in Evaluation of Lung Cancer Patients
30 Years
80 Years
Both
Lung Cancer
Trial Information
Safety and Diagnostic Performance of 99mTc-3PRGD2 SPECT/CT in Evaluation of Lung Cancer Patients
Integrin αvβ3 is an important member of integrin receptor family and expressed
preferentially on the activated endothelial cells of angiogenesis and some types of tumor
cells, 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 radiolabeled RGD-based peptides have
been developed for non-invasive imaging of integrin αvβ3 expression via single photon
emission computed tomography (SPECT)or positron emission tomography (PET). Among all the RGD
radiotracers studied, several RGD monomers have been investigated in clinical trials, and
the preliminary results demonstrated specific imaging of various types of tumors, and the
tumor uptake correlated well with the level of integrin αvβ3 expression. Recently, several
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, 99mTc-3PRGD2 could be easily
prepared and exhibited excellent in vivo behaviors in animal models. No adverse reactions
are observed in animal models to date.
For the further interests in clinical translation of 99mTc-3PRGD2, an open-label SPECT/CT
study was designed to investigate the safety and diagnostic performance of 99mTc-3PRGD2 in
lung cancer patients. A single dose of nearly 11.1 MBq/kg body weight 99mTc-3PRGD2 ( ≤ 20 µg
3PRGD2) will be intravenously injected into the lung cancer patients. Visual and
semiquantitative method will be used to assess the whole-body planar and thoracic SPECT/CT
images. Adverse events will also be observed in the patients.
Inclusion Criteria:
- Males and females, ≥30 years old
- Thoracic CT and/or 18F-FDG PET/CT diagnosis in suspicion of primary or recurrent lung
cancer.
- The lung cancer will be histologically confirmed or results of histology 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:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Visual and semiquantitative assessment of lesions and biodistribution
Outcome Description:
Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. The semiquantitative analysis will be performed by the same person for all the cases, and the tumor to background ratios(T/B) will be measured.
Outcome Time Frame:
One year
Safety Issue:
No
Principal Investigator
Fang Li, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Department of Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science
Authority:
China: National Natural Science Foundation
Study ID:
PUMCHNM05
NCT ID:
NCT01737112
Start Date:
February 2011
Completion Date:
March 2014
Related Keywords:
- Lung Cancer
- Lung Cancer
- integrin αvβ3 receptor
- 99mTc-3PRGD2
- SPECT/CT
- efficacy and safety
- Lung Neoplasms
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