Clinical trial · Interventional
Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus
Phase I In-vivo Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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) 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiplexed heptapeptides | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multiplexed heptapeptides
- description
- QRH \& KSP sprayed onto area of interest and imaged before and after application
- interventionNames
- Drug: Multiplexed heptapeptides
Primary outcomes (1)
- measure
- Validate the binding of the peptides using the SFE
- timeFrame
- 1 year
- description
- The binding of the fluorescent-labeled peptides (QRH-882260 and KSP-910638G) that bind to EGFR and HER2 using an SFE molecular imaging system (SFE) determined using the tumor-to-background ratio for fluorescence intensities
Secondary outcomes (3)
- measure
- Use of the SFE to detect QRH and KSP via signal to noise ratio (SNR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available