oral malignancies or penile carcinoma who are scheduled for a sentinel node (SN) biopsy., Patients with melanoma of the head/neck or the upper part of the trunk
Conditions
Brief summary
To demonstrate concordance between the SN visualization of 99mTc-nanoscan and ICG-99mTc-nanoscan on preoperative lymphoscintigraphy and SPECT/CT imaging, expecting an average of 3 sentinel nodes per patient. Discordance is defined as more than 1 sentinel node not detected coherently by the tracers.
Detailed description
Number of higher-echelon nodes visualized on preoperative lymphoscintigraphy and SPECT/CT imaging for both tracers (ICG-99mTc-Nanoscan and 99mTc-Nanoscan); 99mTc-Nanoscan is used as reference tracer., Concordance between intraoperative fluorescence and radioactive findings, using: Number and intensity of the fluorescent nodes at time of excision; Number and radioactive signal intensity of the radioactive nodes at time of excision
Interventions
DRUGINDOCYANINE GREEN
Sponsors
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate concordance between the SN visualization of 99mTc-nanoscan and ICG-99mTc-nanoscan on preoperative lymphoscintigraphy and SPECT/CT imaging, expecting an average of 3 sentinel nodes per patient. Discordance is defined as more than 1 sentinel node not detected coherently by the tracers. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of higher-echelon nodes visualized on preoperative lymphoscintigraphy and SPECT/CT imaging for both tracers (ICG-99mTc-Nanoscan and 99mTc-Nanoscan); 99mTc-Nanoscan is used as reference tracer., Concordance between intraoperative fluorescence and radioactive findings, using: Number and intensity of the fluorescent nodes at time of excision; Number and radioactive signal intensity of the radioactive nodes at time of excision | — |
Countries
Netherlands
Outcome results
None listed