No registrations found.
ID
Source
Brief title
Health condition
Melanoma, Breast Cancer, Sentinel Lymph Node Biopsy, FNA/FNAC, Surgery
Melanoom, Mammacarcinoom, Schildwachtklierbiopsy, FNA, Chirurgie
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sensitivity of combined gamma probe and ultrasound guided FNAC of the SN
Secondary outcome
1) SN identification rate >75%
2) Histological results of core needle biopsy versus sentinel node biopsy (surgery) and versus FNAC.
Background summary
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.
Study objective
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.
Study design
Estimated inclusion: 2 years.
Intervention
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
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
010-7041506
d.grunhagen@erasmusmc.nl
Groene Hilledijk 301
Rotterdam 3075 EA
The Netherlands
010-7041506
d.grunhagen@erasmusmc.nl
Inclusion criteria
- New diagnosis of cT1b-4N0M0 cutaneous melanoma or cT1-3N0M0 breast cancer
- Age ≥ 18 years
Exclusion criteria
- 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5062 |
| NTR-old | NTR5193 |
| CCMO | NL52091.078.15 |
| OMON | NL-OMON41742 |