Safety and Feasibility of Immuno-OCT

Barrett Esophagus Clinical Trial

— DETOUR  

Official title:

Determining the Safety and Feasibility of Optical Coherence Tomography and Near Infrared Fluorescence: a Prospective Pilot Intervention Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06008522
• Other study ID #: 11258
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: University Medical Center Groningen
• Contact: W.B. Nagengast, MD, PhD, PharmD
• Phone: +31503612620
• Email: w.b.nagengast[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To improve detection of premalignant lesions in the gastrointestinal tract (the rectum and the esophagus) there is a need for better endoscopic visualization and the ability for targeted biopsies. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labelling the VEGF-A-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye bevacizumab-800CW (IRDye800CW). In several phase I studies and phase II studies, either completed or currently running, in the UMCG, the use of VEGF-A-guided near-infrared (NIR) fluorescence molecular endoscopy (FME) in combination with high-definition white light endoscopy (HD-WLE) shows an improved detection rate of early premalignant lesions. In this study the safety and feasibility of a next generation imaging system will be tested. This system uses immune optical coherence tomography (immuno-OCT) and near infrared fluorescence (NIRF) with the targeted tracer (Bevacizumab-800CW) for improvement of the detection of dysplastic lesions in Barret's esophagus (BE) and colorectal polyp detection. The system provides more depth information and can eventually be used without the guidance of the regular endoscopy system.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: March 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Indication for a therapeutic endoscopy procedure (EMR or ESD);

• Age = 18;

• Written informed consent.

Exclusion Criteria:

• Patients younger than 18 years old;

• Submucosal and invasive esophageal adenocarcinoma (EAC) or colorectal carcinoma (CRC);

• 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 breastfeeding; a negative pregnancy test must be available for women of childbearing potential.

Related Conditions & MeSH terms

• Barrett Esophagus
• Colon Carcinoma

Intervention

Drug:
• Bevacizumab-800CW
Imaging of fluorescently labeled Bevacizumab-800CW using OCT.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Device-related Events (ADEs) and Serious Adverse Device-related Events (SADEs) using immuno-OCT	Any events related to the device.	during procedure
Secondary	Validation of the immuno-OCT system: FME	Validation of the immuno-OCT endoscopy results compared to fluorescence seen in FME imaging results.	During procedure
Secondary	Validation of OCT system: Ex vivo fluorescence imaging	Validation of the immuno-OCT endoscopy results compared to the correlation of ex vivo fluorescent signals to histopathological analysis results.	During procedure
Secondary	validation of OCT system: ex vivo immuno-OCT imaging	Validation of the immuno-OCT endoscopy results compared to the correlation of in vivo and ex vivo immuno-OCT imaging to histopathological analysis results.	During procedure
Secondary	validation of OCT system: immunohistochemistry	Validation of the in vivo immune-OCT endoscopy results by comparing it to histopathological analysis results.	Once, as soon as possible after procedure