Ex Vivo Tumor Visualization and Resection Margin Assessment Using Topically Applied Fluorescent Imaging Agents

NCT06292845 | Recruiting

• 1 other identifier: 11272
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumor, Adult

Keywords

Fluorescence imaging

Outcome Measures

Primary Outcomes (1)

• 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

  through study completion, up to 3 years

Secondary Outcomes (4)

• Imaging agent fluorescence signal intensity on close / tumor-positive resection planes compared with (wide) tumor-negative resection planes, as confirmed by histopathology

  through study completion, up to 3 years

• Difference in tumor-to-background ratio (TBR) between different imaging time windows

  through study completion, up to 3 years

• The concordance between the presence of tumor cells and fluorescence signal

  through study completion, up to 3 years

• Depth of the fluorescence signal on 4-μm tissue slides

  through study completion, up to 3 years

Study Arms (1)

Topical application of a fluorescent imaging agent

EXPERIMENTAL

In this arm the investigators use the 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.

Drug: Topical application of a fluorescent imaging agent

Interventions

Topical application of a fluorescent imaging agent DRUG

The 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.

Also known as: fluorescent imaging agent

Topical application of a fluorescent imaging agent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Terminated surgical procedure.
• No fresh specimen available.
• Participation in a clinical trial for which the patient receives another fluorophore perioperatively.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus University Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Central Study Contacts

Stijn Keereweer, Dr

CONTACT

0107041357; s.keereweer@erasmusmc.nl

Bo Zweedijk, Drs

CONTACT

0107042985; b.zweedijk@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: March 5, 2024
• Study Start: January 16, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)