A phase 2 intervention study: Detection of early esophageal neopastic lesions by quantified fluorescence molecular endoscopy using oral and topical administration of bevacizumab-800CW and cetuximab-800CW

A phase 2 intervention study: Detection of early esophageal neopastic lesions by quantified fluorescence molecular endoscopy using oral and topical administration of bevacizumab-800CW and cetuximab-800CW - Oral fluorescent tracer administration to detect esophageal adenocarcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53297

Enrollment

Registered

2023-05-22

Start date

2023-05-01

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's esophagus

Interventions

Patients will receive oral administration of the tracer bevacizumab-800CW and/or cetuximab-800CW prior to the endoscopy procedure During the procedure standard HD-WLE together with fluorescence endo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - BE patients without dysplasia and with suspected/diagnosed LGD, HGD or superficial EAC and planned diagnostic and/or therapeutic endoscopy - Written informed consent is obtained

Exclusion criteria

Exclusion criteria: - Patients under the age of eighteen. - Submucosal and invasive EAC, also defined as EAC with 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.

Design outcomes

Primary

Measure	Time frame
Primary objectives: The primary objectives are to evaluate the feasibility of oral administration of bevacizumab-800CW and cetuximab-800CW for detection of neoplasia in BE patients compared to HD-WLE to shorten the qFME procedure and test whether combined tracer administration increases lesion detection.	—

Secondary

Measure	Time frame
Secondary objectives: 1. To collect safety data on oral administration of (combined) bevacizumab-800CW and cetuximab-800CW by spraying. 2. To (semi)quantify and evaluate the in vivo NIR fluorescent signal of bevacizumab-800CW and cetuximab-800CW combined by using the spectroscopy probe and compare this to the ex vivo VEGFA/EGFR levels in the resected mucosal lesions and/or biopsies taken. 3. Eventually further specify and objectify the improvement of qFME by standardization and tracer administration, by dose optimization, leading to reduction of unnecessary biopsies.	—

Measure

Time frame

Secondary objectives: 1. To collect safety data on oral administration of (combined) bevacizumab-800CW and cetuximab-800CW by spraying. 2. To (semi)quantify and evaluate the in vivo NIR fluorescent signal of bevacizumab-800CW and cetuximab-800CW combined by using the spectroscopy probe and compare this to the ex vivo VEGFA/EGFR levels in the resected mucosal lesions and/or biopsies taken. 3. Eventually further specify and objectify the improvement of qFME by standardization and tracer administration, by dose optimization, leading to reduction of unnecessary biopsies.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)