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Fluorescence QRH-882260 Peptide Imaging in the Bile Duct

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. Identifier: NCT03438435
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : December 2, 2020
University of Washington
Information provided by (Responsible Party):
Michael Saunders, MD, University of Washington

Brief Summary:
Patients undergoing ERCP procedure with biliary stricture will have epithelial mucosa labeled with QRH-882260 fluorescence peptide that binds to EGFR. A custom mini-cholangioscope will be used to image the luminal surfaces of the biliary duct that are exposed to the fluorescence peptide. The images will be recorded and analyzed for relative fluorescence pattern and intensity and correlated to patient diagnosis and clinical outcomes.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Drug: QRH-882260 Heptapeptide Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fluorescence QRH-882260 Peptide Imaging in the Bile Duct
Actual Study Start Date : April 22, 2019
Actual Primary Completion Date : August 21, 2020
Actual Study Completion Date : August 21, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: QRH-882260 Heptapeptide
Five mL of reconstituted (with sterile 0.9% NaCl) QRH-882260 Cy-5-labeled heptapeptide
Drug: QRH-882260 Heptapeptide
Imaging agent

Primary Outcome Measures :
  1. Treatment-related Adverse Events [ Time Frame: 30 months ]
    Number of treatment-related Adverse Events when using fluorescent imaging with QRH during cholangioscopy

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Male or female, aged 18 to 65
  2. Scheduled for outpatient ERCP
  3. Understands English and is interested in participating
  4. Provides signed and dated informed consent form
  5. Willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

  1. Sleep apnea or respiratory problems
  2. Pregnant or trying to conceive
  3. Known allergy or negative reaction to components of the study product(s)
  4. On active chemotherapy or radiation treatment
  5. Anything that, in the opinion of the investigator, would place the individual at increased risk or preclude the individual's full compliance with or completion of the study

Information from the National Library of Medicine

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 identifier (NCT number): NCT03438435

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United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
D. Kim Turgeon, MD
University of Washington
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Principal Investigator: Michael Saunders, MD Clinical Professor of Medicine
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Responsible Party: Michael Saunders, MD, Clinical Professor of Medicine, University of Washington Identifier: NCT03438435    
Other Study ID Numbers: HUM00130597
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type