99mTc-3PRGD2 SPECT/CT in Lung Cancer Patients (TcRGDLC)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Safety and Diagnostic Performance of 99mTc-3PRGD2 SPECT/CT in Evaluation of Lung Cancer Patients|
- Visual and semiquantitative assessment of lesions and biodistribution [ Time Frame: One year ] [ Designated as safety issue: No ]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.
- Adverse events collection [ Time Frame: One year ] [ Designated as safety issue: Yes ]Adverse events within 5 days after the injection and scanning of the patients will be followed and assessed.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: 99mTc-3PRGD2 SPECT/CT scanning
Determine if 99mTc-3PRGD2 SPECT/CT is safe and effective in diagnosis and evaluation of lung cancer patients.
For patients in suspicion of lung cancer, single intravenous bolus injection of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 on day one of the treatment period, whole-body planar and thoracic SPECT/CT to determine the accumulation of 99mTc-3PRGD2 in the tumors and the other parts of the body.
Other Name: 99mTc-HYNIC-3PRGD2
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737112
|Contact: Fang Li, MDfirstname.lastname@example.org|
|Contact: Zhaohui Zhu, MDemail@example.com|
|Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science||Recruiting|
|Beijing, China, 100730|
|Contact: Fang Li, MD 86-10-69155502 firstname.lastname@example.org|
|Contact: Zhaohui Zhu, MD 86-10-69154196 email@example.com|
|Principal Investigator: Zhaohui Zhu, MD|
|Study Chair:||Fang Li, MD||Department of Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science|