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

Completed

• Conditions: 10027476; melanoma & breast cancer lymph node metastasis; 10040900; 10025309

• Registration Number: NL-OMON41742
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

New diagnosis of cT1b-4N0M0 melanoma or cT1-3N0M0 breast cancer, >/<= 18 years old.

Exclusion Criteria

- Clinically suspect lymph node
- Other known malignancy with potential to disseminate to axillary or groin lymph nodes
- Prior lymph node biopsy
- No SN visible at lymphoscintigraphy

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Feasibility of this intervention is evaluated by assessment of the sensitivity.<br /><br>A sensitivity of at least 90% is favoured. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. A reproduction of reported identification rates (75-100%) is pursued.<br /><br>2. Comparison of histological results of CNB versus SNB and versus FNA.</p><br>