This is a proof-of-principle study, that uses freshly resected human solid tumor specimens to assess the performance of topically applied fluorescent imaging agents for the detection of tumor tissue and close / tumor-positive resection margins ex vivo. Surgery will be performed in conformity with hospital protocol. The study will not interfere with the standard clinical care.
Patients with a biopsy-proven solid tumor, scheduled for surgery at the Erasmus Medical Center.
Signed and dated informed consent obtained before any study-related procedure is performed.
Terminated surgical procedure.
No fresh specimen available.
Participation in a clinical trial for which the patient receives another fluorophore perioperatively.
Single group
Topical application of a fluorescent imaging agent
DrugThe fluorescent imaging agent will be topically applied only onto the resection planes of the freshly resected tumor specimen. During incubation and after each washing steps, visible light and fluorescent overlay images will be acquired using a fluorescence sensitive camera system.
Tumor-to-background ratio (TBR) of the fluorescence signal on the resection specimen surface and on 3-5 mm thick tissue slices.
TBR was calculated by drawing a region of interest (ROI) spanning the tumor, and another in adjacent (muscle) tissue using the imaging system's integrated software
Imaging agent fluorescence signal intensity on close / tumor-positive resection planes compared with (wide) tumor-negative resection planes, as confirmed by histopathology
Signal intensity was determined from a region of interest (ROI) drawn in close / tumor-positive resection planes as well as (wide) tumor-negative resection planes, and comparing them using the imaging system's integrated software.
Difference in tumor-to-background ratio (TBR) between different imaging time windows
TBR was calculated for different imaging time windows, and compared.
The concordance between the presence of tumor cells and fluorescence signal
Overlaying fluorescence images with corresponding H\&E slides
Depth of the fluorescence signal on 4-μm tissue slides
Penetration depth of topically applied fluorescent imaging agents was determined from fluorescence images
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