TriangleNCT03686215 · OUTCOME
Volume of Therapeutic Shaves Removed During Lumpectomy.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- cm^3
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 1, during surgery
What was measured
The median volumes of Lumicell Imaging System - guided shaves (therapeutic shaves) were measured and the median total volume removed during lumpectomy was presented as well. The system was used during the surgery, but the assessment of the outcomes was unknown until the pathology report was available.
Analysis population: mITT and control populations
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.
Standard of Care Arm
The LUM Imaging Device was not used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015.
| Group | Source count |
|---|---|
| Device Intervention: LUM Imaging System Used During Surgery | 357 |
| Standard of Care Arm | 35 |
Reported measurements
Lumpectomy volume
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Device Intervention: LUM Imaging System Used During Surgery | 54 | Not reported | 9.7 | 267.2 | Not reported |
| Standard of Care Arm | 66.8 | Not reported | 10.5 | 308.0 | Not reported |
SOC shave volume
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Device Intervention: LUM Imaging System Used During Surgery | 7.5 | Not reported | 0 | 71.2 | Not reported |
| Standard of Care Arm | 7.7 | Not reported | 0 | 71.9 | Not reported |
SOC total volume
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Device Intervention: LUM Imaging System Used During Surgery | 66.4 | Not reported | 15.1 | 308.7 | Not reported |
| Standard of Care Arm | 76.7 | Not reported | 21.9 | 308 | Not reported |
Therapeutic shave volume
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Device Intervention: LUM Imaging System Used During Surgery | 0 | Not reported | 0 | 61.1 | Not reported |
| Standard of Care Arm | 0 | Not reported | 0 | 0 | Not reported |
Total volume
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Device Intervention: LUM Imaging System Used During Surgery | 77.5 | Not reported | 15.2 | 348.1 | Not reported |
| Standard of Care Arm | 76.7 | Not reported | 21.9 | 308.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.7
- upper Limit
- 267.2
- value
- 54
- group Id
- OG001
- lower Limit
- 10.5
- upper Limit
- 308.0
- value
- 66.8
- title
- Lumpectomy volume
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 71.2
- value
- 7.5
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 71.9
- value
- 7.7
- title
- SOC shave volume
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.1
- upper Limit
- 308.7
- value
- 66.4
- group Id
- OG001
- lower Limit
- 21.9
- upper Limit
- 308
- value
- 76.7
- title
- SOC total volume
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 61.1
- value
- 0
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- title
- Therapeutic shave volume
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.2
- upper Limit
- 348.1
- value
- 77.5
- group Id
- OG001
- lower Limit
- 21.9
- upper Limit
- 308.0
- value
- 76.7
- title
- Total volume
- denoms
- counts
- group Id
- OG000
- value
- 357
- group Id
- OG001
- value
- 35
- units
- Participants
- description
- The median volumes of Lumicell Imaging System - guided shaves (therapeutic shaves) were measured and the median total volume removed during lumpectomy was presented as well. 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
- description
- The LUM Imaging Device was not used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015.
- id
- OG001
- title
- Standard of Care Arm
- param Type
- MEDIAN
- population Description
- mITT and control populations
- reporting Status
- POSTED
- time Frame
- Day 1, during surgery
- title
- Volume of Therapeutic Shaves Removed During Lumpectomy.
- type
- SECONDARY
- unit Of Measure
- cm^3
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice