Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
15
Countries
1
Sites
1
Barrett's esophagus
Determine safety and feasibility of immuno-OCT in vivo imaging with the tracer Bevacizumab-800CW
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 15 Mar 2024 → ongoing
- Decision date (initial)
- 2024-01-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506395-27-00
- ClinicalTrials.gov
- NCT06008522
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
Determine safety and feasibility of immuno-OCT in vivo imaging with the tracer Bevacizumab-800CW
Secondary objectives 4
- Validate the immuno-OCT endoscopy system based on Immunohistochemistry.
- Validate the immuno-OCT endoscopy system based on Fluorescence molecular endoscopy.
- Validate the immuno-OCT endoscopy system based on Ex vivo immuno-OCT imaging
- Validate the immuno-OCT endoscopy system based on Ex vivo fluorescence imaging
Conditions and MedDRA coding
Barrett's esophagus
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- Imaging data and medically relevant information, suitably anonymized, can be shared with biopharmaceutical companies. Furthermore, imaging data and medically relevant information will be shared with the Vrije Universiteit Amsterdam, the Amsterdam University Medical Centers, GlycanScan, the Leiden University Medical Center and the Erasmus University. This is also stated in the patient information provided for this study and an MTA/DTA is already in place.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-503801-12-00 | SLURP; 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 | University Medical Center Groningen |
| 2018-004745-17 | Detection of Early Esophageal Cancer by Near-Infrared Fluorescence molecular Endoscopy using Bevacizumab-800CW | |
| 2013-000333-12 | Visualization of a VEGF-targeted Optical Fluorescent Imaging Tracer in rectal cancer during flexible NIR fluorescence endoscopy A single center feasibility side study of the RAPIDO study (NL36315.042.11) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Indication for a therapeutic endoscopy procedure (EMR or ESD)
- Age ≥ 18
- Written informed consent
Exclusion criteria 7
- Radiation therapy for esophageal or colorectal cancer
- History of infusion reactions to Bevacizumab or other monoclonal antibodies
- Chemotherapy, immunotherapy or surgery 28 days before administration of the tracer
- Non-adjustable hypertension
- Medical or psychiatric conditions that compromise the patient’s ability to give informed consent
- Pregnancy or breast feeding; a negative pregnancy test must be available for women of childbearing potential
- Pacemaker
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Safety evaluation of immuno-OCT imaging: Number of adverse device-related events (ADE’s) and serious adverse device-related events (SADE’s).
- Feasibility of in vivo immuno-OCT imaging and interpretation of the in vivo immuno-OCT results
Secondary endpoints 1
- Validation of the immuno-OCT endoscopy results compared to: Fluorescence seen in FME imaging results; The correlation of ex vivo fluorescent signals to histopathological analysis results; The correlation of in vivo and ex vivo immuno-OCT imaging to histopathological analysis results;
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Avastin 25 mg/ml concentrate for solution for infusion.
PRD2153901 · Product
- Active substance
- Bevacizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS ADMINISTRATION
- 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
- Labeling with IRDye with 800CW
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Wouter Nagengast
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Wouter Nagengast
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitair Medisch Centrum Groningen
Maag-, Darm- en leverziekten, Hanzeplein 1, 9713 GZ, Groningen
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 | 2024-03-15 | 2024-03-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-506395-27-00 for publication | 3 |
| Protocol (for publication) | D1_Protocol_2023-506395-27-00 zonder handtekeningen TC | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC bevacizumab-800CW | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Dutch_2023-506395-27-00 | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-02 | Netherlands | Acceptable 2024-01-22
|
2024-01-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-06 | Netherlands | Acceptable 2024-10-02
|
2024-10-03 |