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

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

September 30, 2013

Study Completion Date

September 30, 2013

Conditions
Barrett's Esophagus
Interventions
DRUG

GI heptapeptide

Investigational Agent Name: GI heptapeptide, Linear, 7 amino acid peptide sequence ASYNYDA with a 5-FITC tag and NH2 terminus. Investigational Agent Administration (see SOP in Appendix C) ASYNYDA-GGGSK-(5-FITC)-NH2 0.8 mg lyophilized powder per single-use amber vial Lyophilized powder reconstituted with 5 ml of 0.9% NaCl Final 100 µM concentration for single, one-time topical application Entire 5 ml volume (100 uM concentration) will be sprayed topically onto esophagus by the nurse/physician during the procedure through a standard endoscopy spray catheter (Olympus Medical, Tokyo Japan, PW-5V-1)

Trial Locations (1)

48109

University of Michigan, Ann Arbor

All Listed Sponsors
lead

University of Michigan

OTHER

NCT01630798 - A In-Vivo Esophageal Protocol for Detection of Neoplasia in the Digestive Tract | Biotech Hunter | Biotech Hunter