Molecular Fluorescence Endoscopy in Patients With Familial Adenomatous Polyposis, Using Bevacizumab-IRDye800CW (FLUOFAP)

University Medical Center Groningen (UMCG)

Status and phase: Completed; Phase 1

Conditions: Adenomatous Polyposis Coli

Treatments: Device: Near infrared fluorescence endoscopy platform; Drug: Bevacizumab-IRDye800CW

Study type: Interventional

Funder types: Other

Identifiers

NCT02113202

2013-002490-22 (EudraCT Number)

NL45148.042.13

Details and patient eligibility

About

There is a need for better visualization of polyps during surveillance endoscopy in patients with hereditary colon cancer syndromes like Familial Adenomatous Polyposis (FAP) and Lynch Syndrome (LS), to improve the adenoma detection rate. Optical molecular imaging of adenoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF) is overexpressed in adenomatous colon tissue versus normal tissue and has proven to be a valid target for molecular imaging. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labeling the VEGF-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye IRDye800CW. The investigators hypothesize that when bevacizumab-IRDye800CW is administered to patients, it accumulates in VEGF expressing adenomas, enabling adenoma visualization using a newly developed near-infrared (NIR) fluorescence endoscopy platform (NL43407.042.13). This hypothesis will be tested in this feasibility study, next to the determination of the optimal tracer dose.

Enrollment: 17 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with genetically or clinically proven Familial Adenomatous Polyposis. Genetically proven: Adenomatous Polyposis Coli (APC)-mutation identified. Clinically proven: more than 100 colorectal polyps at diagnosis
• Age 18 to 70 years
• Written informed consent
• Adequate potential for follow-up

Exclusion criteria

• Medical or psychiatric conditions that compromise the patient's ability to give informed consent
• Proctocolectomy
• MutYH mutation
• Concurrent uncontrolled medical conditions
• Pregnant or lactating women. Documentation of a negative pregnancy test must be available for woman of childbearing potential. Woman of childbearing potential are pre-menopausal women with intact reproductive organs and women less than two years after menopause.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 3 patient groups

Tracer dose: 4.5 mg

Experimental group

Description:

Patients receive three days before the fluorescence endoscopy procedure (with the near infrared fluorescence endoscopy platform) 4.5 mg of the fluorescent tracer bevacizumab-IRDye800CW.

Treatment:

Drug: Bevacizumab-IRDye800CW

Device: Near infrared fluorescence endoscopy platform

Tracer dose: 10 mg

Experimental group

Description:

Patients receive three days before the fluorescence endoscopy procedure (with the near infrared fluorescence endoscopy platform) 10 mg of the fluorescent tracer bevacizumab-IRDye800CW.

Treatment:

Drug: Bevacizumab-IRDye800CW

Device: Near infrared fluorescence endoscopy platform

Tracer dose: 25 mg

Experimental group

Description:

Patients receive three days before the fluorescence endoscopy procedure (with the near infrared fluorescence endoscopy platform) 25 mg of the fluorescent tracer bevacizumab-IRDye800CW.

Treatment:

Drug: Bevacizumab-IRDye800CW

Device: Near infrared fluorescence endoscopy platform