TriangleNCT03693742 · OUTCOME
Salivary Gland 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
- MEAN
- Unit
- SULmax
- Interval / dispersion
- Standard Deviation
- 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 salivary gland (submandibular) accumulation measured by the maximal standardized uptake values corrected for lean body mass (SULmax). For determination of salivary gland uptake, regions of interest will be drawn around the salivary glands, using a standardized contouring method, to measure the SULmax. The average SULmax in the organs 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 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 18F-DCFPyL PET/CT Scan With MSG Drink | 9.9 | 4.8 | Not reported | Not reported | Not reported |
| 18F-DCFPyL PET/CT Scan With Placebo Drink | 15.1 | 6.2 | Not reported | Not reported | Not reported |
Source statistical analyses
- group Description
- Null hypothesis is that there was no difference in uptake of F18-DCFPyL between the MSG and placebo groups. A sample size of 10 achieves 100% power to detect a mean of paired differences of 5.0 (33%) with an estimated standard deviation of differences of 1.0 and with a significance level (alpha) of 0.05 using a one-sided paired t-test. If the estimated standard deviation of differences is 5.0, a sample size of 10 achieves 90% power to detect a mean difference of 5.0 with an alpha of 0.05.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- p Value Comment
- A P value of less than 0.05 was considered significant.
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- group Description
- Null hypothesis is that there was no difference in uptake of F18-DCFPyL between the MSG and placebo groups. A sample size of 10 achieves 100% power to detect a mean of paired differences of 5.0 (33%) with an estimated standard deviation of differences of 1.0 and with a significance level (alpha) of 0.05 using a one-sided paired t-test. If the estimated standard deviation of differences is 5.0, a sample size of 10 achieves 90% power to detect a mean difference of 5.0 with an alpha of 0.05.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- p Value Comment
- A P value of less than 0.05 was considered significant.
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 4.8
- value
- 9.9
- group Id
- OG001
- spread
- 6.2
- value
- 15.1
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 10
- units
- Participants
- description
- Comparison of MSG and placebo 18F-DCFPyL salivary gland (submandibular) accumulation measured by the maximal standardized uptake values corrected for lean body mass (SULmax). For determination of salivary gland uptake, regions of interest will be drawn around the salivary glands, using a standardized contouring method, to measure the SULmax. The average SULmax in the organs will be used for this analysis.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- 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
- Salivary Gland Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL
- type
- PRIMARY
- unit Of Measure
- SULmax
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Preserved source evidence · Not medical advice