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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic sentinel node biopsy with 99mTc-nanoscan and ICG-99mTc-nanoscan | Other | The patient first receives a one-time injection with 99mTc-nanoscan, then a one-time injection with ICG-99mTc-nanoscan, both dosage are according to routine care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan | Drug | Sentinel node biopsy with either ICG-99mTc-nanoscan or 99mTc-nanoscan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concordance between tracers | 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. | Measured at pre-operative imaging |
| Measure | Description | Time Frame |
|---|---|---|
| Higher echelon nodes | Number of higher-echelon nodes visualized on preoperative lymphoscintigraphy and SPECT/CT imaging for both tracers (ICG-99mTc-Nanoscan and 99mTc-Nanoscan); | Measured at pre-operative imaging |
| Concordance between intraoperative fluorescence and radioactive findings |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oscar Brouwer, Dr. | Contact | 0205129111 | o.brouwer@nki.nl | |
| Daphne Rietbergen, Dr. | Contact | 0715269111 | d.d.d.rietbergen@lumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NKI-AVL | Recruiting | Amsterdam | Netherlands |
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| ID | Term |
|---|---|
| D010412 | Penile Neoplasms |
| D008545 | Melanoma |
| D009062 | Mouth Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D021701 | Sentinel Lymph Node Biopsy |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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Number of the fluorescent nodes at time of excision; - Number and radioactive signal intensity of the radioactive nodes at time of excision; |
| Measured at pre-operative imaging |
| Concordance between intraoperative fluorescence and radioactive findings | intensity of the fluorescent nodes at time of excision; | Measured at pre-operative imaging |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D010409 | Penile Diseases |
| D052801 | Male Urogenital Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006258 | Head and Neck Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008197 | Lymph Node Excision |
| D008919 | Investigative Techniques |