Trial Outcomes & Findings for MSG Use With 18F-DCFPyL PET/CT Imaging (NCT NCT03693742)
NCT ID: NCT03693742
Last Updated: 2023-02-21
Results Overview
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.
COMPLETED
NA
10 participants
scan with MSG and 3-7 days later, scan with Placebo (or vice versa)
2023-02-21
Participant Flow
Biochemically recurrent prostate cancer patients were screened from a PSMA study wait list, for eligibility between November 1, 2019 and December 1, 2019 at BC Cancer, Vancouver BC. 10 participants were enrolled between November 4th 2019, and December 5th 2019.
10 of 10 participants were randomized.
Participant milestones
| Measure |
MSG, Then Placebo
After a fasting period of 4 hours, participants first received oral administration of 12.7 g of food grade MSG dissolved in 300 mL low sodium tomato juice, prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan.
Within 1 week, participants returned and after having fasted for 4 hours, then received oral administration of the Placebo (300 mL regular sodium tomato juice) prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan.
|
Placebo, Then MSG
After a fasting period of 4 hours, participants first received oral administration of the Placebo (300 mL regular sodium tomato juice) prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan.
Within 1 week, participants returned and after having fasted for 4 hours, then received oral administration of 12.7 g of food grade MSG dissolved in 300 mL low sodium tomato juice, prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
|
Overall Study
COMPLETED
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MSG, Then Placebo
n=7 Participants
After a fasting period of 4 hours, participants first received oral administration of 12.7 g of food grade MSG dissolved in 300 mL low sodium tomato juice, prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan.
Within 1 week, participants returned and after having fasted for 4 hours, then received oral administration of the Placebo (300 mL regular sodium tomato juice) prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan.
|
Placebo, Then MSG
n=3 Participants
After a fasting period of 4 hours, participants first received oral administration of the Placebo (300 mL regular sodium tomato juice) prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan.
Within 1 week, participants returned and after having fasted for 4 hours, then received oral administration of 12.7 g of food grade MSG dissolved in 300 mL low sodium tomato juice, prior to receiving the 18F-DCFPyL radio-tracer administration for their PET/CT scan.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=7 Participants
|
3 Participants
n=3 Participants
|
10 Participants
n=10 Participants
|
|
Sex/Gender, Customized
Male
|
7 Participants
n=7 Participants
|
3 Participants
n=3 Participants
|
10 Participants
n=10 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: scan with MSG and 3-7 days later, scan with Placebo (or vice versa)Population: All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.
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.
Outcome measures
| Measure |
18F-DCFPyL PET/CT Scan With MSG Drink
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Salivary Gland Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL
|
9.9 SULmax
Standard Deviation 4.8
|
15.1 SULmax
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: scan with MSG and 3-7 days later, scan with Placebo (or vice versa)Population: All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.
Comparison of MSG and placebo 18F-DCFPyL renal accumulation measured by the maximal standardized uptake values corrected for lean body mass (SULmax). For determination of renal uptake, regions of interest will be drawn around the kidneys, using a standardized contouring method, to measure the SULmax. The average SULmax in the organs will be used for this analysis.
Outcome measures
| Measure |
18F-DCFPyL PET/CT Scan With MSG Drink
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Renal Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL
|
27.4 SULmax
Standard Deviation 8.0
|
37.5 SULmax
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: scan with MSG and 3-7 days later, scan with Placebo (or vice versa)Population: All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.
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.
Outcome measures
| Measure |
18F-DCFPyL PET/CT Scan With MSG Drink
n=140 malignant lesions
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
n=142 malignant lesions
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.
|
|---|---|---|
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Tumour Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL
|
2.8 SULmax
Interval 0.7 to 23.4
|
4.4 SULmax
Interval 1.1 to 30.3
|
SECONDARY outcome
Timeframe: 2 hoursVital signs (blood pressure, heart rate and pulse oximetry) will be measured at two time points (before tomato juice and 2 hours after radiotracer injection). All values that fall outside of the normal parameters will be assessed by a physician and reported as an adverse event.
Outcome measures
| Measure |
18F-DCFPyL PET/CT Scan With MSG Drink
n=10 Participants
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
n=10 Participants
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.
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|---|---|---|
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Number of Participants With Tomato Juice (Containing Either MSG or Placebo) Related Adverse Events as Assessed by Abnormal Vital Sign Measurement.
|
0 Participants
|
0 Participants
|
Adverse Events
18F-DCFPyL PET/CT Scan With MSG Drink
18F-DCFPyL PET/CT Scan With Placebo Drink
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place