Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ Lymphoscintigraphy

Not Applicable

Completed

• Conditions: Breast Cancer; Multiple Myeloma
• Interventions: Device: Lymphoscintigraphy with intraoperative gamma probes (GP); Device: Prototype intraoperative handheld gamma camera (pIHGC); Radiation: radioactive Tc99M

• Registration Number: NCT01314963
• Lead Sponsor: Stanford University

Brief Summary

This study evaluates the ability of a prototype intraoperative handheld gamma camera (pIHGC) to image (detect) sentinel lymph nodes (SLNs) in melanoma and breast cancer during surgical excision, as compared to standard of care intraoperative gamma probes (GP). The unit of study in this trial was SNLs rather individual participants. Each device was assessed for relative node detection sensitivity (S) of those SLNs.

Detailed Description

Lymphoscintigraphy is an accepted and commonly-performed procedure used for staging of certain cancers, especially melanoma and breast cancer. It involves injecting a small amount of radioactivity under the skin in order to identify lymph nodes which should be biopsied (ie, the "sentinel lymph node, SLN") to determine if cancer has spread. The study objective was to evaluate the potential benefit of a new, camera-based technology (prototype device) which allows actual images to be obtained intra-operatively in the identification of sentinel nodes.

Each device was assessed for relative node detection sensitivity (S), defined as the proportion of sentinel lymph nodes (SLNs) that were identified with each instrument, with the proportion determined as the number of true positives (TP) divided by the total evaluated (N).

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2011-03-11
• Study First Submitted QC: 2011-03-11
• Study First Posted: 2011-03-15
• Primary Completion: 2012-07-26
• Study Completion: 2012-07-26
• Results First Submitted: 2018-02-22
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-29
• Last Update Submitted: 2018-03-29
• Results First Posted: 2018-04-30
• Last Update Posted: 2018-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gamma probes (GP)	radioactive Tc99M	Standard of care intraoperative gamma probes (GP) currently in use.
Intraoperative handheld Gamma Camera (pIHGC)	radioactive Tc99M	The prototype intraoperative handheld gamma camera (pIHGC)
Gamma probes (GP)	Lymphoscintigraphy with intraoperative gamma probes (GP)	Standard of care intraoperative gamma probes (GP) currently in use.
Intraoperative handheld Gamma Camera (pIHGC)	Prototype intraoperative handheld gamma camera (pIHGC)	The prototype intraoperative handheld gamma camera (pIHGC)

Primary Outcome Measures

Name	Time	Method
Relative Node Detection Sensitivity	1 day	Relative node detection sensitivity (S) was defined as the proportion of sentinel lymph nodes (SLNs) that were identified with each instrument, with the proportion determined as the number of true positives (TP) divided by the total evaluated (N). The outcome result is expressed as the percentage for each device with 95% confidence intervals.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States