NKI-AVL
Amsterdam, Netherlands
NCT Number: NCT06666634
99mTc-nanocolloid, the world wide used hybrid tracer for dynamic sentinel node biopsy, has recently been replaced with 99mTc-nanoscan. The hybrid form (ICG-99mTc-nanoscan) has not yet been validated, to show the similarity between the lymphatic drainage pattern between ICG-99mTc-nanoscan and 99mTc-nanoscan.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Amsterdam, Netherlands
The investigators want to set up this study in analogy with the comparison study which was conducted before the introduction of ICG-99mTc-Nanocolloid (99mTc-Nanocoll vs. ICG-99mTc-Nanocoll (NL26699.031.09 -N09DRF). In particular, the investigators want to validate that the hybrid ICG-99m Tc-Nanoscan shows the same preoperative gland involvement on preoperative lymphoscintigraphy and that the intraoperative signal intensities remain the same. All this to maintain the level of current care.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan
Time frame: Measured at pre-operative imaging
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.
Time frame: Measured at pre-operative imaging
Number of higher-echelon nodes visualized on preoperative lymphoscintigraphy and SPECT/CT imaging for both tracers (ICG-99mTc-Nanoscan and 99mTc-Nanoscan);
Time frame: Measured at pre-operative imaging
Number of the fluorescent nodes at time of excision;
Time frame: Measured at pre-operative imaging
intensity of the fluorescent nodes at time of excision;
The Netherlands Cancer Institute
Other
Acronym: NANOSCAN
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