TriangleNCT03686215 · OUTCOME
Sensitivity of LUM Imaging System on Cancer in the Lumpectomy Cavity
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of tissues with cancer
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 1, during surgery
What was measured
Sensitivity of LUM Imaging System on cancer was calculated as percentage of tissues with cancer that was removed from lumpectomy cavity due to positive detection by LUM Imaging System. The estimates of the instrument diagnostic sensitivity used Generalized Estimating Equations (GEE) approach. This method was used to analyze correlated data which was modeled with generalized linear model having binomial link function and including correlation cluster and matrix information (here within each subject). LUM Imaging System was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available.
Analysis population: modified intent to treat population (mITT) includes subjects injected with LUM015 and LUM Imaging was performed
Groups in this outcome
Device Intervention: LUM Imaging System Used During Surgery
The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.
| Group | Source count |
|---|---|
| Device Intervention: LUM Imaging System Used During Surgery | 357 |
| Group | Source count |
|---|---|
| Device Intervention: LUM Imaging System Used During Surgery | 69 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Device Intervention: LUM Imaging System Used During Surgery | 49.1 | Not reported | 36.4 | 61.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 36.4
- upper Limit
- 61.9
- value
- 49.1
- denom Units Selected
- Tissue with cancer
- denoms
- counts
- group Id
- OG000
- value
- 357
- units
- Participants
- counts
- group Id
- OG000
- value
- 69
- units
- Tissue with cancer
- description
- Sensitivity of LUM Imaging System on cancer was calculated as percentage of tissues with cancer that was removed from lumpectomy cavity due to positive detection by LUM Imaging System. The estimates of the instrument diagnostic sensitivity used Generalized Estimating Equations (GEE) approach. This method was used to analyze correlated data which was modeled with generalized linear model having binomial link function and including correlation cluster and matrix information (here within each subject). LUM Imaging System was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- The LUM Imaging Device was used to examine inside the lumpectomy cavity to determine if the dye indicated any areas that might contain residual tumor. If the imaging tested positive for the cancer cells remaining in the lumpectomy cavity, the surgeon would remove an additional piece of tissue. This process was continued until a negative reading from the device was obtained or a maximum of 2 shaves of additional tissue had been removed. Patients in this arm received the study drug, LUM015. Study Device Arm: LUM015 was administered 2 to 6 hours prior to surgery. The LUM Imaging device was used to assist in the removal of additional tumor tissue.
- id
- OG000
- title
- Device Intervention: LUM Imaging System Used During Surgery
- param Type
- NUMBER
- population Description
- modified intent to treat population (mITT) includes subjects injected with LUM015 and LUM Imaging was performed
- reporting Status
- POSTED
- time Frame
- Day 1, during surgery
- title
- Sensitivity of LUM Imaging System on Cancer in the Lumpectomy Cavity
- type
- PRIMARY
- type Units Analyzed
- Tissue with cancer
- unit Of Measure
- percentage of tissues with cancer
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice