Simplifying the sentinel node procedure in breast cancer using a portable gamma camera in order to replace conventional preoperative lymphatic mapping.

Completed

• Conditions: lymph node; Sentinel node; 10006291

• Registration Number: NL-OMON45614
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 236

Inclusion Criteria

Woman
Proven primary breast cancer
Scheduled for sentinel node procedure at the department of Nuclear Medicine
Able to provide informed consent

Exclusion Criteria

2nd primary in ipsilateral breast
Breast cancer recurrence in ipsilateral breast
DCIS and LCIS

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is the SN detection rate using the PGC in breast cancer<br /><br>compared to the current method, CGC imaging.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Correlation of the SN detection rate with patients subgroups (tumor type,<br /><br>T-stage, etc.)<br /><br>* Utilization of the PGC by nuclear medicine technicians and breast surgeons<br /><br>and the effects on logistics and work-flow at the department of Nuclear<br /><br>Medicine;<br /><br>* PGC SN detection rates correlated to PGC imaging acquisition times.<br /><br>* PGC image quality compared to CGC image quality: SN visualization score (0=no<br /><br>uptake, 1=weak, 2=moderate, 3=intense);<br /><br>* A subjective descriptive analysis of the novel hybrid aspect of the PGC<br /><br>where an optical image is combined with a scintigraphic image to combine<br /><br>functional and anatomical information in a fused image output.</p><br>