Fluorescence QRH-882260 Peptide Imaging in the Bile Duct
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|ClinicalTrials.gov Identifier: NCT03438435|
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : November 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma||Drug: QRH-882260 Heptapeptide||Phase 1|
A Phase 1b study of the safety and efficacy of a topically-administered 7-amino acid peptide labeled with a near-infrared fluorophore Cy5 for detecting neoplastic areas of the bile duct is proposed. The study will test the safety and efficacy of administering this agent (QRH-882260 Heptapeptide) to human subjects undergoing clinically indicated ERCP for the evaluation of biliary disorders.
This is a pilot study of a single study group at a single center. The investigators intend to enroll 12 evaluable subjects. Expected enrollment is one subject every 1 month, so the study should take 12 to 24 months to complete. The expected duration of each subject's participation is 2 to 7 days.
Subjects will be recruited around their standard of care procedure. The endoscopists performing study procedures are all credentialed to do these procedures at the UWMC Digestive Health Center.
ERCP will proceed per UWMC standard of care. The endoscopists performing the procedure will evaluate the potential risk (if any) for the subject to continue with the study procedure. Five mL of the reconstituted QRH-882260 Heptapeptide (~100 μM) will be administered to the site of interest through a catheter in the standard endoscope. Five minutes after QRH-882260 Heptapeptide application, the unbound peptide will be washed off using the endogator irrigator and the residual liquid will be suctioned. Pictures with reflection-light and fluorescence will be taken with the SFE based molecular imaging mini-cholangioscope (MC) inserted via the instrument channel of the standard endoscope before the QRH-882260 Heptapeptide application, immediately after application and then again after the QRH-882260 Heptapeptide is rinsed.
The area of interest identified will be biopsied at the discretion of the endoscopist per clinical care. Any specimens taken will be for clinical care only and will be sent for routine histology per UWMC standard of care.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fluorescence QRH-882260 Peptide Imaging in the Bile Duct|
|Estimated Study Start Date :||January 20, 2019|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: QRH-882260 Heptapeptide
Five mL of reconstituted (with sterile 0.9% NaCl) QRH-882260 Cy-5-labeled heptapeptide
Drug: QRH-882260 Heptapeptide
- Treatment-related Adverse Events [ Time Frame: 30 months ]Number of treatment-related Adverse Events when using fluorescent imaging with QRH during cholangioscopy
- Evaluation of imaging content based on the clinical diagnosis [ Time Frame: 30 months ]Images taken during the procedure will be compared to the clinical diagnosis for the subject for correlation
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): NCT03438435
|Contact: Eric J Seibel, PhD||(206) firstname.lastname@example.org|
|Contact: Jenny Huang||(206) email@example.com|
|Principal Investigator:||Michael Saunders, MD||Clinical Professor of Medicine|