68Ga-AlfatideII for the Differential Diagnosis of of Lung Cancer and Lung Tuberculosis by PET/CT
This study has been completed.
First Posted: June 25, 2015
Last Update Posted: June 25, 2015
Information provided by (Responsible Party):
Comparison of 68Ga-AlfatideII and 18F-FDG in differential diagnosis effectiveness towards the solitary pulmonary nodules of lung cancer or tuberculosis.
|Lung Cancer Lung Tuberculosis||Radiation: 68Ga-labeled peptides of dimer RGD (Alfatide II) and 18F-FDG||Phase 1 Phase 2|
|Study Design:||Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Xijing Hospital:
Primary Outcome Measures:
- Quantitative measurement of standardized uptake values (SUVs) of lesions. [ Time Frame: 1 year ]The quantitative 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:
- Number of participants with adverse events as a measure of safety after 68Ga-NEB injection and PET/CT scanning. [ Time Frame: 1 year ]
|Study Start Date:||March 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
In patients in suspicion of lung cancer or lung tuberculosis; in patients with differential diagnosis difficulties; without treatment or surgery. They underwent a standard routine 18F-FDG PET/CT first, and were injected 10~20MBq 68Ga-Alfatide II in the next day, followed by whole body PET/CT acquisitions.
|Radiation: 68Ga-labeled peptides of dimer RGD (Alfatide II) and 18F-FDG|
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