Detection of Early Esophageal Cancer by NIR-FME. (ESCEND)
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|ClinicalTrials.gov Identifier: NCT03877601|
Recruitment Status : Not yet recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Barrett Esophagus||Drug: Bevacizumab-IRDye800CW Diagnostic Test: Fluorescence endoscopy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Follow-up Intervention Study: Detection of Early Esophageal Cancer by Near-infrared Fluoresence Molecular Endoscopy Using Bevacizumab-800CW|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||September 2021|
Experimental: Topical administration of bevacizumab-800CW
The tracer will be topically administered 5 minutes prior to the fluorescence endoscopy procedure (with the near infrared fluorescence endoscopy platform).
Topical administration of Bevacizumab-IRDye800CW during the endoscopic procedure.
Diagnostic Test: Fluorescence endoscopy
Device: Molecular Fluorescence Endoscopy platform A flexible fluorescence fiber-bundle is attached to a fluorescence camera platform to enable the detection of fluorescence signals. The fluorescence fiber-probe is inserted through the standard working channel of the standard clinical endoscope.
- Fluorescence signal in patients with Barrett's Esophagus [ Time Frame: During the endoscopic procedure ]Evaluating the performance of FME with topical administration of Bevacizumab-800CW for detection of neoplasia in BE patients compared to HD-WLE to make an estimation of the diagnostic accuracy in terms of sensitivity and specificity in order to make a power size calculation for the Phase III trial.
- Ex vivo fluorescence singals [ Time Frame: 2 years ]Correlate and validate fluorescence signals detected in vivo with ex vivo histopathology grade of dysplasia and VEGF expression
- Number of participants with adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR). [ Time Frame: Up to 1 week after administration of tracer ]Data collection as a measure of safety and tolerability regarding administration of Bevacizumab-IRDye800CW
- Interrogate potential new EC biomarkers [ Time Frame: 2 years ]We will perform ex-vivo binding experiments with tracers against GREM1, -SULF1 and -PRKCi on the fresh EMR if available and compare them against the in-vivo WLE/NIR-FME findings. We will analyze the sensitivity and specificity of the novel markers alone or in combination. The targeting moieties will be coupled with different fluorophores allowing for multi-parametric analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877601
|Contact: W.B. Nagengast, MD, PhD, PharmDfirstname.lastname@example.org|
|Contact: R.Y. Gabriels, MSc, MDemail@example.com|
|University Medical Center Groningen|
|Groningen, Netherlands, 9713 GZ|
|Principal Investigator:||W.B. Nagengast, MD, PhD, PharmD||University Medical Center Groningen|