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A Phase 1B In-Vivo Esophageal Protocol for Detection of Neoplasia in the Digestive Tract


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Barrett's Esophagus

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Trial Information

A Phase 1B In-Vivo Esophageal Protocol for Detection of Neoplasia in the Digestive Tract


Inclusion Criteria:



- Subjects with Barrett's Esophagus or esophageal adenocarcinoma with or without
confirmed Barrett's Esophagus

- Subjects who are scheduled for a clinically-indicated upper endoscopic evaluation
and/or intervention (e.g. esophagogastroduodenoscopy (EGD) with biopsies)

- All subjects who are medically cleared for the procedure (e.g. washout for
anticoagulants, co-morbidities) who meet the inclusion/exclusion will be included.
Standard practice guidelines for safely proceeding with the procedure will be
sufficient for our study

- Adults aged 18 years to 100

- Willing and able to sign informed consent

Exclusion Criteria:

- Subjects with known allergy or negative reaction to fluorescein or derivatives

- Subjects who have had an esophagectomy

- Subjects who are also prepped for colonoscopy with the EGD

- Subjects on active chemotherapy or radiation treatment

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

validate binding of the fluorescent-labeled peptide to esophageal neopla

Outcome Description:

The overall aim of this research project is to develop the use of fluorescent-labeled peptides that affinity bind to pre-cancerous mucosa in the digestive tract for use as an imaging agent to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This particular study is a phase Ib, vaidation of efficacy of the topically applied peptide and continuing assessment of safety. To validate binding of the fluorescent-labeled peptide to esophageal neoplasia using an Olympus FITC Endoscopic Molecular Imaging System.

Outcome Time Frame:

1.5 years

Safety Issue:

No

Principal Investigator

Danielle Kim Turgeon, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Food and Drug Administration

Study ID:

HUM00062875

NCT ID:

NCT01630798

Start Date:

July 2012

Completion Date:

Related Keywords:

  • Barrett's Esophagus
  • barrett's esophgus
  • High grade dysplasia
  • Esophageal adenocarcinoma
  • Barrett Esophagus
  • Neoplasms
  • Esophageal Diseases

Name

Location
University of Michigan Ann Arbor, Michigan  48109-0624