Trials / Recruiting
RecruitingNCT04191460
Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer
Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- Sponsor
- Erasmus Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a two-staged clinical trial to investigate the feasibility of intraoperative Fluorescence Imaging (FLI) to adequately assess tumor margins in patients with oral cancer using cRGD-ZW800-1.
Detailed description
Work package I: In WP-I, the preferred dose of the agent for imaging of margins in oral cancer will be determined. The signal-to-noise ratio will be determined in dose group A (n=7), which will receive 0.05 mg/kg of the tracer, 16-20 hours before surgery. After an interim evaluation of this ratio, the second dose group B (n=7) will receive either a higher or a lower dosage (to be determined) of the tracer. After inclusion of all patients (n=14), the dose with the highest intraoperative signal-to-noise ratio will be selected. Work package II: In WP-II, an expansion cohort (n=14) will be added to the group of patients that had received the selected dose in WP-I. In this group of 21 patients, it will be determined if FLI can improve the rate of adequate surgical resection margins. As secondary research questions, the following aspects will be assessed: * sensitivity, specificity, positive and negative predictive values of FLI; * colocalization with immunohistochemistry; * change in surgical management; incremental operation time; * FLI of excised cervical lymph nodes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cRGD-ZW800-1. | Injection of cRGD-ZW800-1 within 48 hours before imaging/surgery |
Timeline
- Start date
- 2022-07-12
- Primary completion
- 2025-05-01
- Completion
- 2025-07-01
- First posted
- 2019-12-09
- Last updated
- 2025-02-26
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT04191460. Inclusion in this directory is not an endorsement.