Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer
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|ClinicalTrials.gov Identifier: NCT04304781|
Recruitment Status : Not yet recruiting
First Posted : March 11, 2020
Last Update Posted : March 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma||Drug: KSP/QRH dimer||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 In-vivo Study of KSP/QRH Heptapeptide Dimer for Detection of Biliary Intra-epithelial Neoplasia|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
Experimental: Dimer Application with SFE imaging
Subjects having a standard-of-care ERCP will have the dimer sprayed on an area of interest in the bile duct and images taken with the SFE.
Drug: KSP/QRH dimer
Peptide 919288G, Lot No. 17081402, Molecular Weight 3577.0, ≥95% purity. Stored at <20°C. Dark green, lyophilized powder in single-use amber vials.
- Contrast in Cell Fluorescence [ Time Frame: 2 years ]The fluorescence intensity will be measured by the target/background (T/B) ratio from suspicious regions of bile duct where the fluorescent-labeled peptide is administered. The intensity of the fluorescence of the abnormal tissue compared to the background tissue intensity will be analyzed using statistical analysis for significance comparing the tissue groups' mean T/B ratios.
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): NCT04304781
|Contact: Danielle Kim Turgeon, MDemail@example.com|
|Contact: Elaine Brady, MBAfirstname.lastname@example.org|