Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-10

Study Completion Date

2019-02-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Esophageal Protocol for Detection of Neoplasia in the Digestive Tract

NCT01391208

Barrett Esophagus Esophageal Adenocarcinoma

COMPLETED PHASE1

A In-Vivo Esophageal Protocol for Detection of Neoplasia in the Digestive Tract

NCT01630798

Barrett's Esophagus

COMPLETED PHASE1

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

NCT03852576

Barrett Esophagus

TERMINATED PHASE1

Endoscopic Multispectral Imaging for the Early Detection of Barrett's Neoplasia

NCT01384864

Barrett's Esophagus Intraepithelial Neoplasia

COMPLETED EARLY_PHASE1

Evaluation of a Miniaturized Microscope Device for the Detection of Barrett's Neoplasia: A Pilot Study

NCT01384227

Barrett's Esophagus

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Barrett Esophagus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Multiplexed heptapeptides

QRH \& KSP sprayed onto area of interest and imaged before and after application

Group Type EXPERIMENTAL

Multiplexed heptapeptides

Intervention Type DRUG

Heptapeptides QRH and KSP

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multiplexed heptapeptides

Heptapeptides QRH and KSP

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No