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

ConditionsBarrett's Esophagus Without DysplasiaBarrett Oesophagitis With DysplasiaEsophageal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Avastin

    Drug

    Orally administered

  • Erbitux

    Drug

    Orally administered

  • 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

Treatment groups

25 Participants
are divided into 3 treatment groups
Group A: Oral bevacizumab-800CWExperimental treatment 2 interventions
Group B: Oral cetuximab-800CW and combined oral cetuximab-800CW and bevacizumab-800CWExperimental treatment 3 interventions
Group C: Combined topical tracer administration bevacizumab-800CW and cetuximab-800CWExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
12 months
2

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

Time frame
12 months

Secondary outcomes

1

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

Blood pressure in millimeters of mercury (mmHg)

Time frame
Five minutes before and ten minutes after tracer administration
2

Heart rate

Beats per minute

Time frame
Five minutes before and ten minutes after tracer administration
3

Temperature

Degrees Celsius

Time frame
Five minutes before and ten minutes after tracer administration
4

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

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center Groningen

Lead sponsor

Source ClinicalTrials.gov
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