To hear about similar clinical trials, please enter your email below
Trial Title:
Oral Bevacizumab-800CW and Cetuximab-800CW Administration to Detect Early Esophageal Adenocarcinomas
NCT ID:
NCT05745857
Condition:
Barrett's Esophagus Without Dysplasia
Barrett Oesophagitis With Dysplasia
Esophageal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Barrett Esophagus
Esophageal Neoplasms
Esophagitis
Bevacizumab
Cetuximab
Conditions: Keywords:
Fluorescence molecular endoscopy
Spectroscopy
Barrett's esophagus
Esophageal adenocarcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Factorial Assignment
Intervention model description:
Arm 1: Oral bevacizumab-800CW If oral administration is feasible the investigators will
move on to arm 2, if it does not seem feasible the investigators will move on to arm 3.
Arm 2: Oral cetuximab-800CW The investigators will move on to combined oral
bevacizumab-800CW/cetuximab-800CW if oral cetuximab-800CW seems feasible. If it does not
seem feasible, they will administer oral bevacizumab-800CW to a control group of
non-dysplastic Barrett's esophagus patients.
Arm 3 (only performed if oral administration does not work) Topical administration of
bevacizumab-800CW compared to combined topical administration of
bevacizumab-800CW/cetuximab-800CW. This group will be expanded if combined administration
increases lesion detection. If this is not the case, the investigators will include a
control group of non-dysplastic patients with Barrett's esophagus as a control group who
will receive topical bevacizumab-800CW.
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Avastin
Description:
Orally administered
Arm group label:
Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW
Arm group label:
Oral bevacizumab-800CW
Arm group label:
Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW
Other name:
Bevacizumab
Intervention type:
Drug
Intervention name:
Erbitux
Description:
Orally administered
Arm group label:
Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW
Arm group label:
Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW
Other name:
Cetuximab
Intervention type:
Device
Intervention name:
Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy
Description:
Fluorescent endoscope fiber and spectroscopy probe will be inserted through the working
channel of the normal clinical therapeutic endoscope
Arm group label:
Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW
Arm group label:
Oral bevacizumab-800CW
Arm group label:
Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW
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.
Detailed description:
However, the investigators hypothesized, that additional lesions can potentially be
identified by simultaneous use of two targeted tracers because of variable expression of
vascular endothelial growth factor A (VEGFA) and epidermal growth factor receptor (EGFR
)within oesophageal adenocarcinoma (EAC). Until now, solely intravenous and topical
administration of the tracers has been investigated. However, optimization of tracer
administration and shortened incubation is necessary for clinical translation and
implementation of this new technique from Barrett's esophagus (BE) expert centers to
regional non-expert centers. BE surveillance procedures normally takes up to 15 minutes
at regional hospitals, of which most of the procedural time is needed to take biopsies
according to the Seattle protocol. Introducing qFME into these hospitals would elongate
the procedure time with at least 10 - 15 minutes. This would increase healthcare costs
and put increased pressure on BE healthcare. Ideally, the gastroenterologist can
immediately start with the qFME procedure without any incubation time while maintaining
the best target-to-background ratios (TBR) possible. Oral administration by drinking the
tracer prior to the procedure would eliminate incubation time and its consequences.
Quantified qFME with oral tracer administration and targeted biopsies could potentially
replace the time-consuming, high miss rate Seattle protocol, improve lesion detection and
decrease global healthcare costs associated with BE.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients under the age of eighteen.
- Submucosal and invasive EAC, also defined as EAC with tumor, node and metastasis
(TNM)-classification other than T1.
- Previous radiation therapy for esophageal cancer
- Known immunoglobulin allergy
- Previous chemotherapy, immunotherapy or related surgery
- Prior bevacizumab or cetuximab treatment
- Medical or psychiatric conditions that compromise the patient's ability to give
informed consent
- Pregnancy or breast feeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Medical Center Groningen
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Contact:
Last name:
Wouter B Nagengast, Prof.
Phone:
+31(0)503615755
Email:
w.b.nagengast@umcg.nl
Start date:
May 2023
Completion date:
December 2024
Lead sponsor:
Agency:
University Medical Center Groningen
Agency class:
Other
Source:
University Medical Center Groningen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05745857
