|- candidate number||22042|
|- NTR Number||NTR5193|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-mei-2015|
|- Secondary IDs||NL52091.078.15 MEC-2015-061|
|- Public Title||Gamma Probe and Ultrasound Guided Fine Needle Aspiration Cytology of the Sentinel Node Trial |
|- Scientific Title||Gamma Probe and Ultrasound Guided Fine Needle Aspiration Cytology of the Sentinel Node Trial|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Mamma carcinoma, Sentinel Lymph Node Biopsy (SLNB)|
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-mei-2015|
|- planned closingdate||1-mei-2017|
|- Target number of participants||120|
|- Interventions||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
|- 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.
|- Timepoints||Estimated inclusion: 2 years.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Dr. D.J. Grünhagen|
|- CONTACT for SCIENTIFIC QUERIES||Dr. D.J. Grünhagen|
|- Sponsor/Initiator ||Erasmus MC Cancer Institute, department of Medical Oncology|
(Source(s) of Monetary or Material Support)
|- Brief 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.|
|- Main changes (audit trail)|
|- RECORD||1-mei-2015 - 12-aug-2017|