Clinical trial · Interventional
Ex Vivo Tumor Visualization and Resection Margin Assessment Using Topically Applied Fluorescent Imaging Agents
NCT06292845CI-TRIAL-00080295SprayDyerecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Topical application of a fluorescent imaging agent | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Topical application of a fluorescent imaging agent
- description
- 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.
- interventionNames
- Drug: Topical application of a fluorescent imaging agent
Primary outcomes (1)
- measure
- Tumor-to-background ratio (TBR) of the fluorescence signal on the resection specimen surface and on 3-5 mm thick tissue slices.
- timeFrame
- through study completion, up to 3 years
- description
- 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
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.