99mTc-3PRGD2 SPECT/CT in Lung Cancer Patients
Conditions
Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
Lung Cancer, integrin αvβ3 receptor, 99mTc-3PRGD2, SPECT/CT, efficacy and safety
Study Type
Interventional
Study Phase
Phase 0
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: 99mTc-3PRGD2
Type: Drug
Overall Status
Recruiting
Summary
This is an open-label SPECT/CT (single photon emission computed tomography / computed tomography) study to investigate the safety and diagnostic performance of 99mTc-3PRGD2 in evaluation of lung cancer patients. A single dose of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the patients in suspicion of lung cancer. Visual and semiquantitative method will be used to assess the whole-body planar and thoracic SPECT/CT images. Any adverse events will be collected from the patients.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 30 Years
Gender: Both
Criteria: 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.
Location
Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science
Beijing, China
Status: Recruiting
Contact: Fang Li, MD - 86-10-69155502 - lifang@pumch.cn
Start Date
February 2011
Completion Date
March 2016
Sponsors
Peking Union Medical College Hospital
Source
Peking Union Medical College Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page