TriangleNCT03693742 · OUTCOME
Tumour Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- SULmax
- Interval / dispersion
- Full Range
- Time frame
- scan with MSG and 3-7 days later, scan with Placebo (or vice versa)
What was measured
Comparison of MSG and placebo 18F-DCFPyL tumour accumulation measured by the maximal standardized uptake values corrected for lean body mass (SULmax). For determination of tumour uptake, all malignant lesions, the SULmax were measured using the PET Edge tool running on MIM. All regions of interest were created in one dataset by a blinded observer, and then saved and compared to the identical location in the second dataset for matched comparisons of activity. The median SULmax in the malignant lesions will be used for this analysis.
Analysis population: All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.
Groups in this outcome
18F-DCFPyL PET/CT Scan With MSG Drink
Participants who received MSG dissolved in juice, in a fasting state, prior to the administration of 18F-DCFPyL, in either the first or second PET/CT scan.
18F-DCFPyL PET/CT Scan With Placebo Drink
Participants who received the Placebo juice, in a fasting state, prior to the administration of 18F-DCFPyL, in either the first or second PET/CT scan.
| Group | Source count |
|---|---|
| 18F-DCFPyL PET/CT Scan With MSG Drink | 10 |
| 18F-DCFPyL PET/CT Scan With Placebo Drink | 10 |
| Group | Source count |
|---|---|
| 18F-DCFPyL PET/CT Scan With MSG Drink | 140 |
| 18F-DCFPyL PET/CT Scan With Placebo Drink | 142 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 18F-DCFPyL PET/CT Scan With MSG Drink | 2.8 | Not reported | 0.7 | 23.4 | Not reported |
| 18F-DCFPyL PET/CT Scan With Placebo Drink | 4.4 | Not reported | 1.1 | 30.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.7
- upper Limit
- 23.4
- value
- 2.8
- group Id
- OG001
- lower Limit
- 1.1
- upper Limit
- 30.3
- value
- 4.4
- denom Units Selected
- malignant lesions
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 10
- units
- Participants
- counts
- group Id
- OG000
- value
- 140
- group Id
- OG001
- value
- 142
- units
- malignant lesions
- description
- Comparison of MSG and placebo 18F-DCFPyL tumour accumulation measured by the maximal standardized uptake values corrected for lean body mass (SULmax). For determination of tumour uptake, all malignant lesions, the SULmax were measured using the PET Edge tool running on MIM. All regions of interest were created in one dataset by a blinded observer, and then saved and compared to the identical location in the second dataset for matched comparisons of activity. The median SULmax in the malignant lesions will be used for this analysis.
- dispersion Type
- Full Range
- groups
- description
- Participants who received MSG dissolved in juice, in a fasting state, prior to the administration of 18F-DCFPyL, in either the first or second PET/CT scan.
- id
- OG000
- title
- 18F-DCFPyL PET/CT Scan With MSG Drink
- description
- Participants who received the Placebo juice, in a fasting state, prior to the administration of 18F-DCFPyL, in either the first or second PET/CT scan.
- id
- OG001
- title
- 18F-DCFPyL PET/CT Scan With Placebo Drink
- param Type
- MEDIAN
- population Description
- All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.
- reporting Status
- POSTED
- time Frame
- scan with MSG and 3-7 days later, scan with Placebo (or vice versa)
- title
- Tumour Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL
- type
- SECONDARY
- type Units Analyzed
- malignant lesions
- unit Of Measure
- SULmax
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice