Barrett's Esophagus Without DysplasiaPhase 2SLURPNCT05745857
Oral Bevacizumab-800CW and Cetuximab-800CW Administration to Detect Early Esophageal Adenocarcinomas
A Phase 2 study testing Avastin, Erbitux and Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy in people with Barrett's Esophagus Without Dysplasia and Barrett Oesophagitis With Dysplasia, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett's Esophagus Without Dysplasia, Barrett Oesophagitis With Dysplasia, Esophageal Adenocarcinoma
- What is being tested?
- Avastin, Erbitux and Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Sep 2023to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, Provincie Groningen, 9713 GZ
Wouter B Nagengast, Prof., +31(0)503615755, w.b.nagengast@umcg.nl
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Barrett's Esophagus Without Dysplasia, Barrett Oesophagitis With Dysplasia, Esophageal Adenocarcinoma
- Being tested
- Avastin, Erbitux, Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy
- Keywords
- Fluorescence molecular endoscopy, Spectroscopy, Barrett's esophagus, Esophageal adenocarcinoma
- Medical subject headings
- Adenocarcinoma Of Esophagus, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvastinDrug
Also called Bevacizumab
Orally administered
ErbituxDrug
Also called Cetuximab
Orally administered
Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopyDevice
Fluorescent endoscope fiber and spectroscopy probe will be inserted through the working channel of the normal clinical therapeutic endoscope
| Study group | Role | What they receive |
|---|---|---|
| Oral bevacizumab-800CW | Experimental | Dose finding of oral bevacizumab-800CW and extend optimal dose group (n = 5 - 10) Receives: Drug: Avastin; Device: Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy |
| Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW | Experimental | 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) Receives: Drug: Avastin; Drug: Erbitux; Device: Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy |
| Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW | Experimental | 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) Receives: Drug: Avastin; Drug: Erbitux; Device: Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of shortening qFME procedural time by oral administration of bevacizumab-800CW and cetuximab-800CW for the detection of BE neoplasia.
Evaluating the performance of qFME with oral administration of bevacizumab-800CW and cetuximab-800CW for detection of neoplasia in BE patients compared to HD-WLE. This comparison will be based on target-to-background rations calculated from the in vivo fluorescence images and quantified by MDSFR/SFF spectroscopy measurements
Measured: 12 months
Evaluate if the combination of tracers improves lesion detection by the number of invisible lesions detected
Increased lesion detection in % compared to previously gathered amount of invisible lesions with topical tracer administration
Measured: 12 months
Secondary outcomes (5)
Collect safety data on oral administration of (combined) bevacizumab-800CW and cetuximab-800CW.
Blood pressure in millimeters of mercury (mmHg)
Measured: Five minutes before and ten minutes after tracer administration
Heart rate
Beats per minute
Measured: Five minutes before and ten minutes after tracer administration
Temperature
Degrees Celsius
Measured: Five minutes before and ten minutes after tracer administration
To (semi)quantify and evaluate the in vivo fluorescent signal of bevacizumab-800CW and cetuximab-800CW
Correlate and validate fluorescence signals detected in vivo with ex vivo histopathology grade of dysplasia and VEGFA and EGFR expression
Measured: 12 months
Eventually further specify and objectify the improvement of qFME by standardisation
Determining optimal pre-set features for gain and exposure times for our fluorescence camera system
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start15 Sep 2023
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's Esophagus Without DysplasiaStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wouter B. Nagengast, Prof. dr., Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745857
- Sponsor's protocol ID
- 16054
- Acronym
- SLURP
- Status last verified
- Apr 2026
- First submitted
- 2 Feb 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05745857
- Acronym / sponsor ID
- SLURP / 16054
- Conditions
- Barrett's Esophagus Without Dysplasia, Barrett Oesophagitis With Dysplasia, Esophageal Adenocarcinoma
- Keywords
- Fluorescence molecular endoscopy, Spectroscopy, Barrett's esophagus, Esophageal adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oral bevacizumab-800CW | Experimental | Drug: Avastin, Device: Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopyDose finding of oral bevacizumab-800CW and extend optimal dose group (n = 5 - 10) |
| Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW | Experimental | Drug: Avastin, Drug: Erbitux, Device: Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopyDose 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) |
| Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW | Experimental | Drug: Avastin, Drug: Erbitux, Device: Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopyThis 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvastinAlso: BevacizumabOrally administered | Drug | Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW, Oral bevacizumab-800CW, Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW |
| ErbituxAlso: CetuximabOrally administered | Drug | Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW, Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW |
| Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopyFluorescent endoscope fiber and spectroscopy probe will be inserted through the working channel of the normal clinical therapeutic endoscope | Device | Combined topical tracer administration bevacizumab-800CW and cetuximab-800CW, Oral bevacizumab-800CW, Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CW |
Primary outcome
Feasibility of shortening qFME procedural time by oral administration of bevacizumab-800CW and cetuximab-800CW for the detection of BE neoplasia.
Time frame: 12 months
Evaluating the performance of qFME with oral administration of bevacizumab-800CW and cetuximab-800CW for detection of neoplasia in BE patients compared to HD-WLE. This comparison will be based on target-to-background rations calculated from the in vivo fluorescence images and quantified by MDSFR/SFF spectroscopy measurements
Evaluate if the combination of tracers improves lesion detection by the number of invisible lesions detected
Time frame: 12 months
Increased lesion detection in % compared to previously gathered amount of invisible lesions with topical tracer administration
5 secondary outcomes
Collect safety data on oral administration of (combined) bevacizumab-800CW and cetuximab-800CW.
Time frame: Five minutes before and ten minutes after tracer administration
Heart rate
Time frame: Five minutes before and ten minutes after tracer administration
Temperature
Time frame: Five minutes before and ten minutes after tracer administration
To (semi)quantify and evaluate the in vivo fluorescent signal of bevacizumab-800CW and cetuximab-800CW
Time frame: 12 months
Eventually further specify and objectify the improvement of qFME by standardisation
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wouter B. Nagengast, Prof. dr. principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avastin, Erbitux and Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy in people with Barrett's Esophagus Without Dysplasia and Barrett Oesophagitis With Dysplasia, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wouter B Nagengast, Prof. dr. (+31(0)503615755, w.b.nagengast@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of shortening qFME procedural time by oral administration of bevacizumab-800CW and cetuximab-800CW for the detection of BE neoplasia. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.