Clinical Studies

NCT04304781 – Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer.  This study aims to establish feasibility for topical use of a fluorescently-labeled (IRDye800CW) peptide heterodimer specific for either human epidermal growth factor (EGFR) and epidermal growth factor receptor 2 (HER2) for early detection of cholangiocarcinoma.  Dates:  10/01/20 – current, Enrollment: 25 subjects

NCT03852576 – Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus.  This Phase IB study aims to establish early evidence of efficacy for a fluorescently-labeled (IRDye800CW) peptide heterodimer specific for human epidermal growth factor (EGFR) and epidermal growth factor receptor 2 (HER2) for early detection of cancer in patients with Barrett’s esophagus.  Dates:  02/25/19 – current, Enrollment: 50 subjects

NCT03643068 – Phase 1A Study of the Safety of KSP/QRH Dimer in Humans for the Early Detection of GI Malignancies.  This Phase I study aims to establish safety of a fluorescently-labeled (IRDye800CW) peptide heterodimer specific for human epidermal growth factor (EGFR) and epidermal growth factor receptor 2 (HER2) for early detection of cancer in the digestive tract.  Dates:  08/22/18 – 10/27/18, Enrollment: 26 subjects

NCT03589443 – Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus

The aim of this project is to combine the use of a panel of fluorescent-labeled peptides that bind specifically to pre-cancerous mucosa in the esophagus that overexpresses either human epidermal growth factor (EGFR) orepidermal growth factor receptor 2 (HER2) for use as novel imaging agents to guide endoscopic biopsy or endoscopic mucosal resection in patients with Barrett’s esophagus.  Dates:  05/10/18 – 02/04/19, Enrollment: 27 subjects

NCT03220711 – Study of Performance of Confocal Endomicroscope with Fluorescein Imaging Agent in the Colon

The aim of this project is to evaluate the imaging performance of a novel confocal endomicroscope to provide real-time "histology" to guide endoscopic biopsy or endoscopic mucosal resection (EMR).  Dates:  07/28/17 – current, Enrollment: 50 subjects

NCT03161418 – Study of the Safety of KSP-910638G Heptapeptide

This Phase I study aims to establish safety of a fluorescently-labeled (IRDye800CW) peptide specific for human epidermal growth factor receptor 2 (HER2) for early detection of esophageal cancer.  Dates:  06/01/17 – 12/01/17, Enrollment: 25 subjects

NCT03148119 – Study of QRH-882260 Heptapeptide Application in the Colon

This Phase IB imaging study aims to establish early evidence of efficacy for a near-infrared fluorescently-labeled (Cy5) peptide specific for epithelial growth factor receptor (EGFR) for early detection of colorectal cancer.  Dates:  03/31/17 – current, Enrollment: 120 subjects

NCT02574858 – Study of the Safety of QRH-882260 Heptapeptide

This Phase I study aims to establish safety of a fluorescently-labeled (Cy5) peptide specific for epithelial growth factor receptor (EGFR) for early detection of colorectal cancer.

Dates:  10/07/15 – 10/24/16, Enrollment: 25 subjects

NCT02156557 – Study of KCC Peptide Application in the Colon

This Phase IB imaging study aims to establish early evidence of efficacy for for endoscopic detection of flat and subtle sessile serrated adenomas (SSA) in the proximal (right) colon using a topically-administered fluorescently-labeled (FITC) peptide.  Dates:  06/03/14 – 08/01/16, Enrollment: 40 subjects

NCT01722058 – A Phase 1 In-Vivo Peptide Applied to the Right Colon

This Phase I study aims to establish safety of a fluorescently-labeled (FITC) peptide imaging specific for flat and subtle sessile serrated adenomas (SSA) in the proximal (right) colon.  Dates:  10/30/12 – 11/14/13, Enrollment: 25 subjects

NCT01630798 – A In-Vivo Esophageal Protocol for Detection of Neoplasia in the Digestive Tract

This Phase IB imaging study aims to establish early evidence of efficacy for endoscopic detection of high-grade dysplasia and early adenocarcinoma in patients with Barrett’s esophagus using a topically-administered fluorescently-labeled (FITC) peptide.  Dates:  06/26/12 – 10/07/15, Enrollment: 60 subjects

NCT01391208 – Esophageal Protocol for Detection of Neoplasia in the Digestive Tract

This Phase I study aims to establish safety of a topically-administered fluorescently-labeled (FITC) peptide for early detection of cancer in the esophagus.

Dates:  07/01/11 – 10/10/12, Enrollment: 25 subjects