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Fluorescence QRH-882260 Peptide Imaging in the Bile Duct

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ClinicalTrials.gov Identifier: NCT03438435
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : August 27, 2019
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Michael Saunders, MD, University of Washington

Tracking Information
First Submitted Date  ICMJE January 30, 2018
First Posted Date  ICMJE February 19, 2018
Last Update Posted Date August 27, 2019
Actual Study Start Date  ICMJE April 22, 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
Treatment-related Adverse Events [ Time Frame: 30 months ]
Number of treatment-related Adverse Events when using fluorescent imaging with QRH during cholangioscopy
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03438435 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluorescence QRH-882260 Peptide Imaging in the Bile Duct
Official Title  ICMJE Fluorescence QRH-882260 Peptide Imaging in the Bile Duct
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Cholangiocarcinoma
Intervention  ICMJE Drug: QRH-882260 Heptapeptide
Imaging agent
Study Arms  ICMJE Experimental: QRH-882260 Heptapeptide
Five mL of reconstituted (with sterile 0.9% NaCl) QRH-882260 Cy-5-labeled heptapeptide
Intervention: Drug: QRH-882260 Heptapeptide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 12, 2018)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eric J Seibel, PhD (206) 616-1486 eseibel@u.washington.edu
Contact: Jenny Huang (206) 221-8069 chuang@medicine.washington.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03438435
Other Study ID Numbers  ICMJE HUM00130597
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Saunders, MD, University of Washington
Study Sponsor  ICMJE D. Kim Turgeon, MD
Collaborators  ICMJE University of Washington
Investigators  ICMJE
Principal Investigator: Michael Saunders, MD Clinical Professor of Medicine
PRS Account University of Michigan
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP