Detection of Early Esophageal Cancer by Near-Infrared Fluorescence molecular Endoscopy using Bevacizumab-800CW - Fluorescence endoscopy of early stages of esophageal cancer.

niversity Medical Center Groningen0 sites60 target enrollmentJanuary 31, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with Barretts esophagus and there is a suspicion for at least low grade dysplasia.
Sponsor: niversity Medical Center Groningen
Enrollment: 60
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

January 31, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Suspicion or diagnosed LGD, HGD or superficial EAC and planned diagnostic and/or therapeutic endoscopy.
•Mentally competent person, 18 years or older.
•dequate potential for 5\-year follow\-up.
•Written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 50
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 10

•Patients younger than 18 years old
•Submucosal and invasive EAC; EAC with TNM\-classification other than T1\.
•Radiation therapy for esophageal cancer
•Immunoglobulin allergy
•Chemotherapy, immunotherapy or surgery 28 days before administration of the tracer
•Prior Bevacizumab treatment
•Non\-adjustable hypertension
•Medical or psychiatric conditions that compromise the patient’s ability to give informed consent.
•Pregnancy or breast feeding.