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NCT Number: NCT05745857

Oral Bevacizumab-800CW and Cetuximab-800CW Administration to Detect Early Esophageal Adenocarcinomas

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Medical Center Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location status: Recruiting

Location contact

Wouter B Nagengast, Prof.

CONTACT

[email protected]

+31(0)503615755

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Avastin

Drug

Orally administered

Other names: Bevacizumab

ERBITUX

Drug

Orally administered

Other names: Cetuximab

Fluorescence endoscopy and multi-diameter single fiber reflectance/single fiber fluorescence (MDSFR/SFF) spectroscopy

Device

Fluorescent endoscope fiber and spectroscopy probe will be inserted through the working channel of the normal clinical therapeutic endoscope

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Collect safety data on oral administration of (combined) bevacizumab-800CW and cetuximab-800CW.

    Time frame: Five minutes before and ten minutes after tracer administration

    Blood pressure in millimeters of mercury (mmHg)

  2. Heart rate

    Time frame: Five minutes before and ten minutes after tracer administration

    Beats per minute

  3. Temperature

    Time frame: Five minutes before and ten minutes after tracer administration

    Degrees Celsius

  4. To (semi)quantify and evaluate the in vivo fluorescent signal of bevacizumab-800CW and cetuximab-800CW

    Time frame: 12 months

    Correlate and validate fluorescence signals detected in vivo with ex vivo histopathology grade of dysplasia and VEGFA and EGFR expression

  5. Eventually further specify and objectify the improvement of qFME by standardisation

    Time frame: 12 months

    Determining optimal pre-set features for gain and exposure times for our fluorescence camera system

Study contacts

Contact information is provided by the study sponsor or research team.

Wouter B Nagengast, Prof. dr.

CONTACT

[email protected]

+31(0)503615755

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study 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

Acronym: SLURP

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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