Using fluorescent imaging agents to improve tumor removal during surgery
Ex Vivo Tumor Visualization and Resection Margin Assessment Using Topically Applied Fluorescent Imaging Agents
This study is testing a new way to help surgeons see and remove all of the cancer during surgery by using special fluorescent dyes that highlight tumor tissue.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT06292845 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of topically applied fluorescent imaging agents on freshly resected human solid tumor specimens to identify tumor tissue and assess resection margins. The goal is to enhance the accuracy of surgical excisions by providing real-time feedback on the presence of tumor cells at the margins. By improving the detection of tumor-positive margins, the study aims to reduce the need for additional treatments that can lead to increased morbidity and healthcare costs. The approach does not interfere with standard clinical care and is designed to complement existing surgical techniques.
Who should consider this trial
Good fit: Ideal candidates are adults with biopsy-proven solid tumors who are scheduled for surgery at the Erasmus Medical Center.
Not a fit: Patients whose surgical procedures are terminated or who do not have fresh specimens available will not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could lead to more complete tumor resections and better patient outcomes by reducing the rates of inadequate surgical margins.
How similar studies have performed: While fluorescence imaging is an emerging technique, this specific application for real-time margin assessment in solid tumors is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with a biopsy-proven solid tumor, scheduled for surgery at the Erasmus Medical Center. 2. Signed and dated informed consent obtained before any study-related procedure is performed. Exclusion Criteria: 1. Terminated surgical procedure. 2. No fresh specimen available. 3. Participation in a clinical trial for which the patient receives another fluorophore perioperatively.
Where this trial is running
Rotterdam, South Holland
- Erasmus University Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Stijn Keereweer, Dr
- Email: s.keereweer@erasmusmc.nl
- Phone: 0107041357
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.