Breast Cancer, Multiple Myeloma
Conditions
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).
Interventions
DEVICEPrototype 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 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.
DEVICELymphoscintigraphy with intraoperative gamma probes (GP)
Lymphoscintigraphy with standard of care intraoperative gamma probes (GP)
RADIATIONradioactive Tc99M
Lymphoscintigraphy involves injection of 0.4 to 1.0 mCi of radioactive Tc99M sulfur colloid around at the tumor site.
Sponsors
Whitaker Foundation
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants This study evaluates the ability of 2 procedures to detect sentinel lymph nodes (SLNs), and does not evaluate between groups of participants. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Customized 18 years old or greater | 50 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 50 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 50 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 50 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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.
Time frame: 1 day
Population: Sentinel lymph nodes (SLNs) were evaluated for detection by the 2 methods.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intraoperative Handheld Gamma Camera (pIHGC) | Relative Node Detection Sensitivity | 88.5 Percentage (%) of SLNs detected |
| Gamma Probes (GP) | Relative Node Detection Sensitivity | 94.2 Percentage (%) of SLNs detected |