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Gamma Probe and Ultrasound Guided Fine Needle Aspiration Cytology of the Sentinel Node Trial

Suspended
Conditions
Melanoma, Breast Cancer, Sentinel Lymph Node Biopsy, FNA/FNAC, SurgeryMelanoom, Mammacarcinoom, Schildwachtklierbiopsy, FNA, Chirurgie
Registration Number
NL-OMON21922
Lead Sponsor
Erasmus MC Cancer Institute
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Suspended
Sex
Not specified
Target Recruitment
120
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Sensitivity of combined gamma probe and ultrasound guided FNAC of the SN<br>
Secondary Outcome Measures
NameTimeMethod
1) SN identification rate >75%<br /><br>2) Histological results of core needle biopsy versus sentinel node biopsy (surgery) and versus FNAC.
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