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Trial record 2 of 277977 for:    ALL

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
Sponsor:
Information provided by (Responsible Party):
Danielle Kim Turgeon, University of Michigan

Brief Summary:
The overall aim of this feasibility study is to develop new technologies for improved detection of Barrett's neoplasia using the SFE multiplexed imaging system. This study will combine the use of fluorescent-labeled peptides that bind specifically to pre-cancerous mucosa in the esophagus for use as novel imaging agents to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This Phase 1 study will be used to provide early evidence of efficacy for the topical application of a panel of two peptides that bind to molecular targets that are specific for esophageal dysplasia. A panel is needed because cancer in the esophagus is genetically heterogeneous. The study will look at peptide binding in subjects with known or suspected Barrett's esophagus.

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)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
Experimental: Multiplexed heptapeptides
QRH & KSP sprayed onto area of interest and imaged before and after application
Drug: Multiplexed heptapeptides
Heptapeptides QRH and KSP




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Known or suspected Barrett's esophagus
  • Scheduled for a clinically-indicated upper endoscopy
  • Medically cleared for the procedure
  • Willing and able to sign informed consent

Exclusion Criteria:

  • Known allergy or negative reaction to the near infrared fluorophores Cy5, li-cor IRDye800CW, or derivatives
  • One active chemotherapy or radiation treatment
  • Pregnant or trying to conceive

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 ClinicalTrials.gov identifier (NCT number): NCT03589443


Contacts
Contact: Danielle Kim Turgeon, MD 734-764-6860 kturgeon@med.umich.edu
Contact: Elaine M Brady, MBA 734-647-4794 embrady@med.umich.edu

Locations
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Danielle K Turgeon, MD         
Sponsors and Collaborators
University of Michigan

Responsible Party: Danielle Kim Turgeon, Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT03589443     History of Changes
Other Study ID Numbers: HUM00137993
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases