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 Title of Study: “Efficacy of a Novel, High-Sensitivity, Portable, Hand-Held Gamma Camera Used Intraoperatively for Identification of Sentinel Lymph Nodes With Lymphoscintigraphy”
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: July 26, 2012
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).
- Device: Prototype intraoperative handheld gamma camera (pIHGC)
- The prototype intraoperative handheld gamma camera (pIHGC) consists of a parallel-hole lead collimator coupled to a pixilated sodium iodide-thallium [NaI(Tl)] scintillation crystal array, itself coupled to a flat panel, multi-anode Hamamatsu H8500 position-sensitive photomultiplier tube. The collimator is 5×5 cm2 large in area and 1.5 cm thick, with 1.3 mm hexagonal holes and 0.2 mm septa. The 1.7 mm pitch crystal array is composed of 29×29 individual crystals, each 1.5×1.5×6 mm3 in size.
- Device: Lymphoscintigraphy with intraoperative gamma probes (GP)
- Lymphoscintigraphy with standard of care intraoperative gamma probes (GP)
- Radiation: radioactive Tc99M
- Lymphoscintigraphy involves injection of 0.4 to 1.0 mCi of radioactive Tc99M sulfur colloid around at the tumor site.
Arms, Groups and Cohorts
- Experimental: Intraoperative handheld Gamma Camera (pIHGC)
- The prototype intraoperative handheld gamma camera (pIHGC)
- Active Comparator: Gamma probes (GP)
- Standard of care intraoperative gamma probes (GP) currently in use.
Clinical Trial Outcome Measures
- Relative Node Detection Sensitivity
- Time Frame: 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.
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Stanford University
- Whitaker Foundation
- Provider of Information About this Clinical Study
- Principal Investigator: John B. Sunwoo, Assistant Professor of Otolaryngology – Head and Neck Surgery – Stanford University
- Overall Official(s)
- John B Sunwoo, MD, Principal Investigator, Stanford University
Citations Reporting on Results
Olcott P, Pratx G, Johnson D, Mittra E, Niederkohr R, Levin CS. Clinical evaluation of a novel intraoperative handheld gamma camera for sentinel lymph node biopsy. Phys Med. 2014 May;30(3):340-5. doi: 10.1016/j.ejmp.2013.10.005. Epub 2013 Nov 14.
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