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Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus

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ClinicalTrials.gov Identifier: NCT03852576
Recruitment Status : Not yet recruiting
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
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 scanning fiber endoscope (SFE) imaging system. This study will combine the use of a fluorescent-labeled peptide dimer that bind specifically to pre-cancerous mucosa in the esophagus for use as a novel imaging agent to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This Phase 1B study will be used to provide early evidence of efficacy for the topical application of a peptide dimer that binds to molecular targets, including EGFR and HER2, that are specific for esophageal dysplasia. A dimer is needed because cancer in the esophagus is genetically heterogeneous. QRH binds specifically to Epidermal Growth Factor Receptor (EGFR), and KSP binds specifically to Human Epithelial Growth Factor Receptor (HER2). 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: KSP/QRH dimer Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase 1B In-vivo Study of KSP/QRH Heptapeptide Dimer for Detection of Neoplasia in the Esophagus
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Arm Intervention/treatment
Experimental: Esophagus sprayed with KSP/QRH dimer
Area of interest in subject's esophagus sprayed with KSP/QRH dimer and imaged with the SFE probe
Drug: KSP/QRH dimer
KSP-QRH-E3-IRDye800 (Peptide 919288G)




Primary Outcome Measures :
  1. Binding of KSP/QRH dimer to EGFR and HER2 [ Time Frame: 2 years ]
    Validation of the dimer to EGFR and HER2 using target-to-background ratio of the suspicious region compared to the background

  2. SFE ability to detect dimer by SNR [ Time Frame: 2 years ]
    SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using signal-to-noise ratio (SNR)

  3. SFE ability to detect dimer by fluorescence T/B ratio [ Time Frame: 2 years ]
    SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using fluorescence tumor-to-background (T/B) ratio

  4. SFE ability to detect dimer with contrast [ Time Frame: 2 years ]
    SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using contrast



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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:

  • Has known or suspected Barrett's esophagus
  • Scheduled for a clinically-indicated, upper endoscopy
  • Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities)
  • Age 18 to 100 years
  • Willing and able to sign informed consent

Exclusion Criteria:

  • Subjects with known allergy or negative reaction to the near infrared fluorophore IRDye800CW, or derivatives
  • Subjects on 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): NCT03852576


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

Sponsors and Collaborators
University of Michigan

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Responsible Party: Danielle Kim Turgeon, Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT03852576     History of Changes
Other Study ID Numbers: HUM00158121
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019

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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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Barrett Esophagus
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases