Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus
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|ClinicalTrials.gov Identifier: NCT03589443|
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : July 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Barrett Esophagus||Drug: Multiplexed heptapeptides||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I In-vivo Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus|
|Actual Study Start Date :||May 10, 2018|
|Estimated Primary Completion Date :||May 10, 2019|
|Estimated Study Completion Date :||November 3, 2019|
Experimental: Multiplexed heptapeptides
QRH & KSP sprayed onto area of interest and imaged before and after application
Drug: Multiplexed heptapeptides
Heptapeptides QRH and KSP
- Validate the binding of the peptides using the SFE [ Time Frame: 1 year ]The binding of the fluorescent-labeled peptides (QRH-882260 and KSP-910638G) that bind to EGFR and HER2 using a scanning fiber-based molecular imaging system (SFE) determined using the tumor-to-background ratio for fluorescence intensities
- Use of the SFE to detect QRH and KSP via signal to noise ratio (SNR) [ Time Frame: 1 year ]One aspect of feasibility will be shown by examining the SNR of the images collected.
- Use of the SFE to detect QRH and KSP via tumor-to-background ratio [ Time Frame: 1 year ]One aspect of feasibility will be shown by examining the tumor-to-background ratio of the images collected.
- Use of the SFE to detect QRH and KSP via contrast [ Time Frame: 1 year ]One aspect of feasibility will be shown by examining the contrast in the two channels in the images collected.
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): NCT03589443
|Contact: Danielle Kim Turgeon, MDemail@example.com|
|Contact: Elaine M Brady, MBAfirstname.lastname@example.org|
|United States, Michigan|
|University of Michigan Hospital||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Danielle K Turgeon, MD|