Clinical trial NCT03852576: Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus
Official title: Phase 1B In-vivo Study of KSP/QRH Heptapeptide Dimer for Detection of Neoplasia in the Esophagus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Barrett Esophagus
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Binding of KSP/QRH dimer to EGFR and HER2
timeFrame: During and immediately after procedure, generally no more than 2 hours
measure: SFE ability to detect dimer by SNR
timeFrame: During and immediately after procedure, generally no more than 2 hours
measure: SFE ability to detect dimer by fluorescence T/B ratio
timeFrame: During and immediately after procedure, generally no more than 2 hours
measure: SFE ability to detect dimer with contrast
timeFrame: During and immediately after procedure, generally no more than 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Danielle K Turgeon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen J, Jiang Y, Chang TS, Rubenstein JH, Kwon RS, Wamsteker EJ, Prabhu A, Zhao L, Appelman HD, Owens SR, Beer DG, Turgeon DK, Seibel EJ, Wang TD. Detection of Barrett's neoplasia with a near-infrared fluorescent heterodimeric peptide. Endoscopy. 2022 Dec;54(12):1198-1204. doi: 10.1055/a-1801-2406. Epub 2022 Mar 17.