melanoma of the head and neck, melanoma of the trunk, melanoma of an extremity, sentinel node biopsy
Conditions
Interventions
Day 1:
Surrounding the melanoma (scar) the 4 sites for the radiocolloid injection deposits will be marked with an indelible marker pen. Thereafter, 0.4 mL of 90MBq (±10%) 99mTc-Senti-Scint will be a
Sponsors
NKI-AVL
Eligibility
Inclusion criteria
Inclusion criteria: • Patients >18 years; • Patients with a primary melanoma of the trunk , of an extremity or in the head and neck region; • Patients with a clinically node negative (N0) regional lymph node status; • Patients are scheduled for (re-)excision of the melanoma (scar) with a sentinel node biopsy.
Exclusion criteria
Exclusion criteria: • Patients with known allergy to patent blue; • Patients who are pregnant or nursing mothers; • History of hypersensitivity reactions to products containing human serum albumin; • History of iodine allergy; • Hyperthyroid or thyroidal adenoma; • Kidney insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number of draining basins and sentinel nodes visualized with lymphoscintigraphy and SPECT/CT imaging; 2.Number of higher-echelon nodes visualized with lymphoscintigraphy and SPECT/CT imaging; 3.Number of visualized sentinel nodes with a clear lymphatic vessel running from the injection site to the sentinel node. The parameters mentioned will be studied for both ICG-99mTc-nanocolloid and 99mTc-Senti-Scint. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of fluorescent and radioactive nodes at the time of excision; 2. Number of radioactive nodes only at the time of excision; 3. Number of fluorescent, radioactive and blue nodes at the time of excision; 4. Number of radioactive and blue nodes at the time of excision; 5. Histopathological examination results of the excised sentinel nodes. | — |
Contacts
Public ContactJ.A. Hage, van der
Outcome results
None listed