A Phase 2 Intervention Study: Detection of Early Esophageal Neoplastic Lesions by Quantified Fluorescence Molecular Endoscopy Using Oral and Topical Administration of Bevacizumab-800CW and Cetuximab-800CW
Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Previous studies have confirmed the great potential of quantitative fluorescence molecular endoscopy (qFME) when looking at additional lesion detection initially missed by high-definition white light endoscopy (HD-WLE) for surveillance of Barrett's esophagus.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• BE patients without dysplasia and with suspected/diagnosed low-grade dysplasia (LGD), high-grade dysplasia (HGD) or superficial EAC and planned diagnostic and/or therapeutic endoscopy
• Written informed consent is obtained
Locations
Other Locations
Netherlands
University Medical Center Groningen
RECRUITING
Groningen
Contact Information
Primary
Wouter B Nagengast, Prof. dr.
w.b.nagengast@umcg.nl
+31(0)503615755
Time Frame
Start Date: 2023-09-15
Estimated Completion Date: 2026-12
Participants
Target number of participants: 25
Treatments
Experimental: Oral bevacizumab-800CW
Dose finding of oral bevacizumab-800CW and extend optimal dose group (n = 5 - 10)
Experimental: Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW
Dose finding of oral cetuximab-800CW in first five patients and combined oral bevacizumab-800CW and cetuximab-800CW if the investigators see good results with cetuximab-800CW. If not, they will add a control group of non-dysplastic BE patients and administer oral bevacizumab-800CW.~(n = 15)
Experimental: Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW
This arm will only be part of the study when oral administration is not feasible or safe.~Compare single topical tracer administration of bevacizumab-800CW with combined topical tracer administration of bevacizumab-800CW and cetuximab-800CW. Extend combined group when lesion detection is increased or add control group with non-dysplastic BE patients if not.~(n = 20)
Related Therapeutic Areas
Sponsors
Leads: University Medical Center Groningen