Detection of early stages of esophageal cancer with fluorescence molecular endoscopy.
- Conditions
- Patients with Barretts esophagus and there is a suspicion for at least low grade dysplasia.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-004745-17-NL
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method