Fluorescence Endoscopy of Esophageal Carcinoma (ORCA)
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|ClinicalTrials.gov Identifier: NCT03558724|
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : November 21, 2018
For locally advanced esophageal cancer (EC), neoadjuvant chemoradiotherapy (nCRT) for 5 weeks followed by esophagectomy and lymphadenectomy, if necessary, is standard of care. It is reported that the pathological complete response (pCR) rate after nCRT ranges from 16% to 43%, with a median of 26.5%. According to current clinical guidelines, patients who achieved pCR still go for surgery even though those patients who achieved pCR may not benefit from surgery. Besides, about 50% of EC patients may have post-operative complications including pneumonia, anastomotic leakage, recurrent laryngeal nerve paralysis, which lead to low health-related quality of life (HQoL).
The golden standard to test the pathological response is by pathological assessment of the surgical specimen and thus after surgery. Theoretically, if pCR after nCRT can be predicted accurately before surgery by advanced imaging techniques, patients could have a wait-and-see. The wait-and-see procedure includes regular follow-up and salvage surgery if recurrence is present. Therefore, molecular fluorescence endoscopy (FME) using near-infrared fluorescence (NIRF) tracer bevacizumab-800CW targeting vascular endothelial growth factor combined with high-definition white light (HD-WL) endoscopy is expected to be a promising technique to monitor pCR and fill the gap.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: Bevacizumab-IRDye800CW Device: Molecular Fluorescence Endoscopy platform||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fluorescence Molecular Endoscopy of Locally Advanced Esophageal Carcinoma Using Bevacizumab-800CW to Evaluate Dose Response After Neoadjuvant Chemoradiotherapy: a Single-center Feasibility Study.|
|Actual Study Start Date :||October 29, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: NIR endoscopy with bevacizumab-800CW
A non-randomized, non-blinded, prospective, feasibility study.
Intravenous administration of 4.5 mg (microdose) of Bevacizumab-IRDye800CW prior to the endoscopic procedure
Other Name: Tracer administration
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 imaging will be performed prior to and post the chemoradiotherapy.
Other Name: Fluorescence Endoscopy
- Discrimination of tumorous and non-tumorous tissue based on in vivo and ex vivo fluorescence measurements from bevacizumab-800CW gained during fluorescence endoscopy procedure [ Time Frame: Three days after tracer injection ]To determine the sensitivity of the marker bevacizumab-800CW in discriminating between tumorous and non-tumorous tissue prior to and post neoadjuvant chemoradiotherapy, to identify patients who benefit from the chemoradiotherapy.
- Safety of bevacizumab-800CW administration by monitoring vital signs and/or (serious) adverse events. [ Time Frame: Up to 14 days after tracer injection ]Monitoring vital signs (blood pressure, heart frequency and temperature) and/or (serious) adverse events that are related to the administration of bevacizumab-800CW
- The correlation of in vivo and ex vivo fluorescent signals to histopathological analysis results [ Time Frame: Up to 1,5 year ]
- Quantification of the fluorescent signal by MDSFR/SFF spectroscopy [ Time Frame: Up to 1,5 year ]Multi-diameter single-fiber reflectance with single-fiber fluorescence (MDSFR/SFF) spectroscopy can measure the fluorescence signal quantitatively, both in vivo and ex vivo.
- To localization and distribution of bevacizumab-800CW fluorescent signal at cell level observed in vivo by confocal laser endomicroscopy (CLE) [ Time Frame: Up to 1,5 year ]CLE is a confocal laser endomicroscopy system which enables in vivo microscopic images of the tissue
- Assessment of the (sub)-cellular distribution of bevacizumab-800CW by ex vivo fluorescence microscopy [ Time Frame: Up to 1,5 year ]
- The variation in fluorescence intensity between fluorescence molecular endoscopy before and after neoadjuvant chemoradiotherapy defined as the tumor to background ratio and intrinsic fluorescence. [ Time Frame: Up to 1,5 year ]Both the images and specific measurements are used to calculate the fluorescence intensity (TBR & intrinsic fluorescence) and a difference between the before and after intensity is calculated.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558724
|Contact: W. B. Nagengast, MD, PhD, PharmDemail@example.com|
|Contact: I. Schmidt, MScfirstname.lastname@example.org|
|University Medical Center Groningen||Recruiting|
|Groningen, Netherlands, 9713 GZ|
|Contact: W. B. Nagengast, MD, PhD, PharmD +31503612620 email@example.com|
|Contact: I. Schmidt, MSc +31655256244 firstname.lastname@example.org|
|Principal Investigator: W. B. Nagengast, MD, PhD, PharmD|
|Principal Investigator: G. M. van Dam, MD, PhD|
|Principal Investigator:||W. B. Nagengast, MD, PhD, PharmD||University Medical Center Groningen|
|Principal Investigator:||G. M. van Dam, MD, PhD||University Medical Center Groningen|