Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02113202
Other study ID # NL45148.042.13
Secondary ID 2013-002490-22
Status Completed
Phase Phase 1
First received
Last updated
Start date March 2014
Est. completion date October 2015

Study information

Verified date October 2023
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Intervention

Drug:
Bevacizumab-IRDye800CW
Intravenous administration of a 4.5 mg, 10 mg or 25 mg of Bevacizumab-IRDye800CW 3 days prior to the fluorescence endoscopy procedure.
Device:
Near infrared fluorescence endoscopy platform
A flexible fiber-bundle is attached with its proximal end to a camera which can detect near infrared fluorescent light. The distal end is inserted into the working channel of a clinical video endoscope, which is used for the surveillance endoscopy procedure.

Locations

Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of fluorescent adenomatous polyps during surveillance endoscopy using the near-infrared fluorescence endoscopy platform in patients with Familial Adenomatous Polyposis (FAP), after administration of the fluorescent tracer bevacizumab-IRDye800CW. The main objective of this study is to determine the sensitivity of the fluorescent tracer bevacizumab-IRDye800CW and the near-infrared fluorescence endoscopy platform in identifying adenomatous polyps during surveillance endoscopy in patients with Familial Adenomatous Polyposis (FAP). At surveillance endoscopy
Secondary Meassure the mean fluorescent intensity of the polyps during fluorescence endoscopy, resect the polyps and score VEGF intensity after immunohistochemistry for VEGF. In this outcome meassure, it is determined if there is a correlation between the observed mean fluorescence intensity of a polyp and the VEGF expression in the same polyp, as determined with immunohistochemistry and eventually RNA/DNA analysis. In other words, does the mean fluorescence intensity reflect the VEGF expression of the polyp? Two years
Secondary Number of participants with Serious Adverse Events as a measure of safety and Tolerability. Collection of safety data regarding administration of Bevacizumab-IRDye800CW (adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR)). Up to 1 week after administration
Secondary Measure the mean fluorescent intensity of adenomas and compare this between the three different dosing groups to determine the best tracer dose for the fluorescence endoscopy procedure. The goal of this outcome measure, is to determine the optimal tracer dose (4.5, 10 or 25 mg) of bevacizumab-IRDye800CW for the molecular-guided fluorescence endoscopy procedure to visualize adenomas. The fluorescence intensity of adenomas will be measured in vivo during fluorescence endoscopy and ex vivo (e.g. using confocal fluorescence microscopy, spectroscopy). This will be compared between the three subgroups (patients with different time intervals between tracer injection and endoscopy procedure) to determine the best time interval between tracer injection and endoscopy procedure. Two years
See also
  Status Clinical Trial Phase
Terminated NCT00585312 - Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP) Phase 3
Completed NCT03095703 - Sirolimus and Familial Adenomatous Polyposis (FAP) Phase 2
Completed NCT03649971 - A Study of Guselkumab in Participants With Familial Adenomatous Polyposis Phase 1
Completed NCT05014360 - A Study of JNJ-64251330 in Participants With Familial Adenomatous Polyposis Phase 1
Completed NCT01604564 - Registry With Information About Colitis Ulcerosa and Familial Adenomatous Polyposis Patients
Recruiting NCT05919264 - FOG-001 in Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Withdrawn NCT03027401 - Clinical Sequencing of Cancer and Tissue Repository: OncoGenomics
Recruiting NCT06435533 - Cold Atmospheric Plasma for the Endoscopic Treatment of Duodenal Polyps in Patients With Familial Adenomatous Polyposis N/A
Terminated NCT00140894 - A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP) (0966-205)(TERMINATED) Phase 4
Active, not recruiting NCT01187901 - A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients Phase 2
Recruiting NCT00319007 - Influence of Sulindac and Probiotics on the Development of Pouch Adenomas in Patients With Familial Adenomatous Polyposis Phase 2
No longer available NCT04948398 - Post-Trial Access for Guselkumab in Participants With Familial Adenomatous Polyposis