TriangleNCT01314963 · OUTCOME
Relative Node Detection Sensitivity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage (%) of SLNs detected
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 1 day
What was measured
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.
Analysis population: Sentinel lymph nodes (SLNs) were evaluated for detection by the 2 methods.
Groups in this outcome
Intraoperative Handheld Gamma Camera (pIHGC)
The prototype intraoperative handheld gamma camera (pIHGC) radioactive Tc99M: Lymphoscintigraphy involves injection of 0.4 to 1.0 mCi of radioactive Tc99M sulfur colloid around at the tumor site.
Gamma Probes (GP)
Lymphoscintigraphy with standard of care intraoperative gamma probes (GP) radioactive Tc99M: Lymphoscintigraphy involves injection of 0.4 to 1.0 mCi of radioactive Tc99M sulfur colloid around at the tumor site.
| Group | Source count |
|---|---|
| Intraoperative Handheld Gamma Camera (pIHGC) | 50 |
| Gamma Probes (GP) | 50 |
| Group | Source count |
|---|---|
| Intraoperative Handheld Gamma Camera (pIHGC) | 104 |
| Gamma Probes (GP) | 104 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Intraoperative Handheld Gamma Camera (pIHGC) | 88.5 | Not reported | 82.3 | 94.6 | Not reported |
| Gamma Probes (GP) | 94.2 | Not reported | 89.7 | 98.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 82.3
- upper Limit
- 94.6
- value
- 88.5
- group Id
- OG001
- lower Limit
- 89.7
- upper Limit
- 98.7
- value
- 94.2
- denom Units Selected
- Sentinel lymph nodes (SLNs)
- denoms
- counts
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 50
- units
- Participants
- counts
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 104
- units
- Sentinel lymph nodes (SLNs)
- description
- 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.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- The prototype intraoperative handheld gamma camera (pIHGC) radioactive Tc99M: Lymphoscintigraphy involves injection of 0.4 to 1.0 mCi of radioactive Tc99M sulfur colloid around at the tumor site.
- id
- OG000
- title
- Intraoperative Handheld Gamma Camera (pIHGC)
- description
- Lymphoscintigraphy with standard of care intraoperative gamma probes (GP) radioactive Tc99M: Lymphoscintigraphy involves injection of 0.4 to 1.0 mCi of radioactive Tc99M sulfur colloid around at the tumor site.
- id
- OG001
- title
- Gamma Probes (GP)
- param Type
- NUMBER
- population Description
- Sentinel lymph nodes (SLNs) were evaluated for detection by the 2 methods.
- reporting Status
- POSTED
- time Frame
- 1 day
- title
- Relative Node Detection Sensitivity
- type
- PRIMARY
- type Units Analyzed
- Sentinel lymph nodes (SLNs)
- unit Of Measure
- Percentage (%) of SLNs detected
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice