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

Stanford University

Status: Completed

Conditions: Breast Cancer; Multiple Myeloma

Treatments: Device: Lymphoscintigraphy with intraoperative gamma probes (GP); Device: Prototype intraoperative handheld gamma camera (pIHGC); Radiation: radioactive Tc99M

Study type: Interventional

Funder types: Other

Identifiers

NCT01314963

SU-03092011-7560 (Other Identifier)

IRB-06037

MEL0004 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

INCLUSION CRITERIA

• Malignancy for which sentinel node biopsy with lymphoscintigraphy are indicated as part of the standard of care for tumor staging
• Age 18 or greater.
• Healthy enough for surgery
• Able to understand and willing to sign a written informed consent document.

EXCLUSION CRITERIA

• No exclusion requirements due to co-morbid disease or intercurrent illness.
• Documented allergy to colloid.
• Lymphoscintigraphy presents excessive high risk, eg, a consideration if pregnant or lactating

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intraoperative handheld Gamma Camera (pIHGC)

Experimental group

Description:

The prototype intraoperative handheld gamma camera (pIHGC)

Treatment:

Radiation: radioactive Tc99M

Device: Prototype intraoperative handheld gamma camera (pIHGC)

Gamma probes (GP)

Active Comparator group

Description:

Standard of care intraoperative gamma probes (GP) currently in use.

Treatment:

Radiation: radioactive Tc99M

Device: Lymphoscintigraphy with intraoperative gamma probes (GP)