Status:
UNKNOWN
Detection of Early Esophageal Cancer by NIR-FME.
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Helmholtz Zentrum München
Conditions:
Barrett Esophagus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of patients at risk of developing malignancies, for example in Barrett's Esophagus (BE), there is a need for bet...
Detailed Description
See brief summary
Eligibility Criteria
Inclusion
- Suspicion or diagnosed LGD, HGD or superficial EAC and planned diagnostic and/or therapeutic endoscopy.
- Age: 18 years or older.
- Written informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
July 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03877601
Start Date
July 29 2019
End Date
October 1 2021
Last Update
November 4 2020
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ