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| ID | Type | Description | Link |
|---|---|---|---|
| SU-03092011-7560 | Other Identifier | Stanford University | |
| MEL0004 | Other Identifier | OnCore |
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| Name | Class |
|---|---|
| Whitaker Foundation | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative handheld Gamma Camera (pIHGC) | Experimental | The prototype intraoperative handheld gamma camera (pIHGC) |
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| Gamma probes (GP) | Active Comparator | Standard of care intraoperative gamma probes (GP) currently in use. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prototype intraoperative handheld gamma camera (pIHGC) | Device | 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 5x5 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 29x29 individual crystals, each 1.5x1.5x6 mm3 in size. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Node Detection Sensitivity | 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. | 1 day |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| John B Sunwoo, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24239343 | Result | 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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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | This study evaluates the ability of 2 procedures to detect sentinel lymph nodes (SLNs), and does not evaluate between groups of participants. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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The unit of study in this trial was sentinel lymph nodes (SLNs) rather individual participants. with the comparison conducted by evaluation of each SLN with the prototype intraoperative handheld gamma camera (pIHGC) and standard of care intraoperative gamma probes (GP).
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| Lymphoscintigraphy with intraoperative gamma probes (GP) | Device | Lymphoscintigraphy with standard of care intraoperative gamma probes (GP) |
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| radioactive Tc99M | Radiation | Lymphoscintigraphy involves injection of 0.4 to 1.0 mCi of radioactive Tc99M sulfur colloid around at the tumor site. |
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| COMPLETED |
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| NOT COMPLETED |
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The required data for baseline results is participant-level data. This study is a comparison of lesion-level data sets, ie, a comparison of intra-participant data. It is not possible to segregate participant baseline data to one group or the other of the intra-participant datasets.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | This study evaluates the ability of 2 procedures to detect sentinel lymph nodes (SLNs), and does not evaluate between groups of participants. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | All available information on age is provided. Some data are missing, specifically whether or not certain participants were older or younger than age 65. Therefore the number of participants 18 to 65 vs the number of participants older than 65 is not available. | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relative Node Detection Sensitivity | 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. | Sentinel lymph nodes (SLNs) were evaluated for detection by the 2 methods. | Posted | Number | 95% Confidence Interval | Percentage (%) of SLNs detected | 1 day | Sentinel lymph nodes (SLNs) | Sentinel lymph nodes (SLNs) |
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1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants - Intraoperative Handheld Gamma Camera (pIHGC | The entire set of sentinel lymph nodes (SLNs) excised from study participants (ie, all participants) were evaluated with the intraoperative handheld gamma camera (pIHGC). | 0 | 50 | 0 | 50 | 0 | 50 |
| EG001 | All Participants - Gamma Probes (GP) | The entire set of sentinel lymph nodes (SLNs) excised from study participants (ie, all participants) were evaluated with the gamma probes (GP). | 0 | 50 | 0 | 50 | 0 | 50 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Craig Levin, PhD; Professor of Radiology (Molecular Imaging Program at Stanford/Nuclear Medicine) | Stanford Univeristy Medical Center | 650-736-0449 | cslevin@stanford.edu |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D061305 | Lymphoscintigraphy |
| ID | Term |
|---|---|
| D011877 | Radionuclide Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003947 | Diagnostic Techniques, Radioisotope |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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