Gamma probe and ultrasound guided fine needle aspiration cytology (FNAC) of the sentinel node (SN) is an accurate and sensitive minimally invasive alternative to the gold standard of surgical resection of the sentinel node in melanoma and breast…
ID
Bron
Verkorte titel
Aandoening
Melanoma, Breast Cancer, Sentinel Lymph Node Biopsy, FNA/FNAC, Surgery
Melanoom, Mammacarcinoom, Schildwachtklierbiopsy, FNA, Chirurgie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Sensitivity of combined gamma probe and ultrasound guided FNAC of the SN
Achtergrond van het onderzoek
Sentinel node biopsy detects clinically occult metastases of breast cancer and melanoma in 20-30%. The remaining 70-80% of patients remain negative, but nonetheless are exposed to potential morbidity in up to 10%, consisting of wound infections, seroma and even lymph edema.
Ultrasound imaging to detect metastases in the sentinel node is not accurate enough to replace surgical removal of the sentinel node. Additional use of the standard peroperatively used gamma probe has been reported to improve the identification rate of the sentinel node, enabling the possibility to accurately perform FNAC.
This study aims to provide a minimally invasive alternative for surgical sentinel node biopsy, combining use of a gamma probe and ultrasound for FNAC of the sentinel node in melanoma and breast cancer patients.
Doel van het onderzoek
Gamma probe and ultrasound guided fine needle aspiration cytology (FNAC) of the sentinel node (SN) is an accurate and sensitive minimally invasive alternative to the gold standard of surgical resection of the sentinel node in melanoma and breast cancer patients.
Onderzoeksopzet
Estimated inclusion: 2 years.
Onderzoeksproduct en/of interventie
All: preoperative gamma probe and ulstrasound guided FNAC of the sentinel node (SN).
First 10 Breast cancer patients: additional core needle biopsy of SN
First 10 patients (excluding first 10 breast cancer patients): additional marker placement in SN
Publiek
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
010-7041506
d.grunhagen@erasmusmc.nl
Wetenschappelijk
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
010-7041506
d.grunhagen@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- New diagnosis of cT1b-4N0M0 cutaneous melanoma or cT1-3N0M0 breast cancer
- Age ≥ 18 years
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Clinically suspect lymph node
- Other known malignancy with potential to disseminate to axillary or groin lymph node basins.
- Prior lymph node biopsy
- No SN visible at lymphoscintigraphy / not identifiable with gamma probe.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL5062 |
NTR-old | NTR5193 |
CCMO | NL52091.078.15 |
OMON | NL-OMON41742 |