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Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Real-time Fluorescence Imaging
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Erasmus University Medical Center
Rotterdam, South Holland, Netherlands
Start Date
July 12, 2022
Primary Completion Date
May 1, 2025
Completion Date
July 1, 2025
Last Updated
February 26, 2025
28
ESTIMATED participants
cRGD-ZW800-1.
DRUG
Lead Sponsor
Erasmus Medical Center
NCT05075980
NCT05815927
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06736379