TriangleNCT03686215 · OUTCOME
Detection and Conversion of Positive Margins.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 1, during surgery
What was measured
Detection of positive margins: Percentage of patients with positive margins after standard of care breast-conserving surgery, all had LUM Imaging System signals above the threshold in the cavity as defined by the tumor detection algorithm. Conversion of positive margins: Percentage of patients with positive margins after standard of care breast-conserving surgery resulted in the negative margin after LUM Imaging System was used. The 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 |
Reported measurements
Percentage among participants having positive margins after SoC all detected by LUM Imaging System
| Group | Source count |
|---|---|
| Device Intervention: LUM Imaging System Used During Surgery | 62 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Device Intervention: LUM Imaging System Used During Surgery | 16.1 | Not reported | 8.0 | 27.7 | Not reported |
Percentage of participants with positive SOC margins converted to negative with LUM Imaging System
| Group | Source count |
|---|---|
| Device Intervention: LUM Imaging System Used During Surgery | 62 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Device Intervention: LUM Imaging System Used During Surgery | 14.5 | Not reported | 6.9 | 25.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.0
- upper Limit
- 27.7
- value
- 16.1
- denoms
- counts
- group Id
- OG000
- value
- 62
- units
- Participants
- title
- Percentage among participants having positive margins after SoC all detected by LUM Imaging System
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.9
- upper Limit
- 25.8
- value
- 14.5
- denoms
- counts
- group Id
- OG000
- value
- 62
- units
- Participants
- title
- Percentage of participants with positive SOC margins converted to negative with LUM Imaging System
- denoms
- counts
- group Id
- OG000
- value
- 357
- units
- Participants
- description
- Detection of positive margins: Percentage of patients with positive margins after standard of care breast-conserving surgery, all had LUM Imaging System signals above the threshold in the cavity as defined by the tumor detection algorithm. Conversion of positive margins: Percentage of patients with positive margins after standard of care breast-conserving surgery resulted in the negative margin after LUM Imaging System was used. The 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
- Detection and Conversion of Positive Margins.
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice