Overview
Sponsor-declared trial summary
Barrett's esophagus
The primary objectives are to evaluate the feasibility of oral administration of bevacizumab-800CW and cetuximab-800CW with quantified fluorescence molecular endoscopy (qFME) for detection of neoplasia in Barrett's esophagus (BE) patients compared to high-definition white-light endoscopy (HD-WLE) to shorten the qFME pr…
Key facts
- Sponsor
- University Medical Center Groningen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Neoplasms [C04]
- Trial duration
- 15 Sep 2023 → 7 May 2026
- Decision date (initial)
- 2023-05-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- University Medical Center Groningen
External identifiers
- EU CT number
- 2023-503801-12-00
- ClinicalTrials.gov
- NCT05745857
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Diagnosis, Dose response
The primary objectives are to evaluate the feasibility of oral administration of bevacizumab-800CW and cetuximab-800CW with quantified fluorescence molecular endoscopy (qFME) for detection of neoplasia in Barrett's esophagus (BE) patients compared to high-definition white-light endoscopy (HD-WLE) to shorten the qFME procedure and test whether combined tracer administration further increases lesion detection.
Secondary objectives 3
- To collect safety data on oral administration of (combined) bevacizumab-800CW and cetuximab-800CW.
- To (semi)quantify and evaluate the in vivo near-infrared fluorescent signal of bevacizumab-800CW and cetuximab-800CW combined by using the spectroscopy probe and compare this to the ex vivo vascular endothelial growth factor A (VEGFA)/epidermal growth factor receptor (EGFR) levels in the resected mucosal lesions and/or biopsies taken.
- Eventually further specify and objectify the improvement of qFME by standardization and tracer administration, by dose optimization, leading to reduction of unnecessary biopsies
Conditions and MedDRA coding
Barrett's esophagus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10004137 | Barrett's oesophagus | 100000004856 |
Regulatory references
| EU CT number | Title | Sponsor |
|---|---|---|
| 2018-004745-17 | Detection of Early Esophageal Cancer by Near-Infrared Fluorescence molecular Endoscopy using Bevacizumab-800CW |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- BE patients without dysplasia and with suspected/diagnosed low-grade dysplasia (LGD), high-grade dysplasia (HGD) or superficial esophageal adenocarcinoma (EAC) and planned diagnostic and/or therapeutic endoscopy
- Written informed consent is obtained
Exclusion criteria 8
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Feasibility and safety of oral tracer administration
- Evaluate combined tracer administration lead for increased lesion detection
Secondary endpoints 3
- Safety data on oral (combined) tracer administration
- Quantify in vivo fluorescent signal and compare to ex vivo expression of VEGFA/EGFR
- Specify and objectify the improvement of qFME and tracer administration
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Erbitux 5 mg/mL solution for infusion
PRD327539 · Product
- Active substance
- Cetuximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- ORAL
- Max daily dose
- 21 mg/kg milligram(s)/kilogram
- Max total dose
- 21 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FE01 — -
- Marketing authorisation
- EU/1/04/281/003
- MA holder
- MERCK EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Conjugated to the fluorescent molecule IRDye 800CW
Avastin 25 mg/ml concentrate for solution for infusion
PRD2153901 · Product
- Active substance
- Bevacizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- ORAL
- Max daily dose
- 60 mg/kg milligram(s)/kilogram
- Max total dose
- 60 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FG01 — -
- Marketing authorisation
- EU/1/04/300/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Conjugated tot the fluorescent molecule IRDye 800CW
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Medical Center Groningen
- Sponsor organisation
- University Medical Center Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- University Medical Center Groningen
- Contact name
- W.B. Nagengast
Public contact point
- Organisation
- University Medical Center Groningen
- Contact name
- W.B. Nagengast
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 25 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2023-09-15 | 2026-05-07 | 2023-09-15 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-16 | Netherlands | Acceptable with conditions 2023-05-22
|
2023-05-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-08-18 | Netherlands | Acceptable 2023-09-21
|
2023-09-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-11-09 | Netherlands | Acceptable 2024-02-08
|
2024-02-08 |