Study of 18F-Fluoro-PEG6-IPQA
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01320059|
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : June 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: 18F-PEG6-IPQA Procedure: Positron emission tomography (PET)||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of 18F-Fluoro-PEG6-IPQA as a PET Imaging Agent for Active/Mutant EGFR Expression in Tumors|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Experimental: Imaging with 18F-PEG6-IPQA
Radioactive injection given by vein before multiple (3) PET scans.
Radioactive injection (PET imaging agent) given by vein before PET scans.
Procedure: Positron emission tomography (PET)
3 PET scans performed after injection and positioning CT. Imaging should take about 3 hours.
- Optimum dosimetry of 18F-PEG6-IPQA sodium injection based on critical organ safety [ Time Frame: Safety measurements performed from administration of injection until 2 weeks after administration. ]Optimum dosimetry of 18F-PEG6-IPQA injection for each cohort derived from previous cohort based on statistical evaluation of critical organ exposure and safety limitations. Safety measurements performed from administration of 18F-PEG6-IPQA injection until 2 weeks after administration. The biodistribution of 18F-PEG6-IPQA will be measured during positron emission tomography (PET) scans. The percent injected dose (%ID) obtained in different organs will be derived from the PET data.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320059
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Donald Podoloff, MD,BA||M.D. Anderson Cancer Center|