TriangleNCT03693742 · STUDY IN CONTEXT
MSG Use With 18F-DCFPyL PET/CT Imaging
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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.
Vital 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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03693742
- trial label
- MSG Use With 18F-DCFPyL PET/CT Imaging
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 4
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03693742
- outcome key
- om-0000
- source section id
- NCT03693742-om-0000
- source outcome index
- 0
- endpoint
- Salivary Gland Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL
- endpoint definition
- 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.
- time origin
- scan with MSG and 3-7 days later, scan with Placebo (or vice versa)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03693742
- outcome key
- om-0001
- source section id
- NCT03693742-om-0001
- source outcome index
- 1
- endpoint
- Renal Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL
- endpoint definition
- 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.
- time origin
- scan with MSG and 3-7 days later, scan with Placebo (or vice versa)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03693742
- outcome key
- om-0002
- source section id
- NCT03693742-om-0002
- source outcome index
- 2
- endpoint
- Tumour Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL
- endpoint definition
- 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.
- time origin
- scan with MSG and 3-7 days later, scan with Placebo (or vice versa)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03693742
- outcome key
- om-0003
- source section id
- NCT03693742-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants With Tomato Juice (Containing Either MSG or Placebo) Related Adverse Events as Assessed by Abnormal Vital Sign Measurement.
- endpoint definition
- Vital 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.
- time origin
- 2 hours
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03693742
- outcome key
- om-0000
- arm key
- OG000
- arm label
- 18F-DCFPyL PET/CT Scan With MSG Drink
- regimen
- 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.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03693742-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03693742
- outcome key
- om-0000
- arm key
- OG001
- arm label
- 18F-DCFPyL PET/CT Scan With Placebo Drink
- regimen
- 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.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03693742-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03693742
- outcome key
- om-0001
- arm key
- OG000
- arm label
- 18F-DCFPyL PET/CT Scan With MSG Drink
- regimen
- 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.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03693742-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03693742
- outcome key
- om-0001
- arm key
- OG001
- arm label
- 18F-DCFPyL PET/CT Scan With Placebo Drink
- regimen
- 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.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03693742-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03693742
- outcome key
- om-0002
- arm key
- OG000
- arm label
- 18F-DCFPyL PET/CT Scan With MSG Drink
- regimen
- 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.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03693742-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03693742
- outcome key
- om-0002
- arm key
- OG001
- arm label
- 18F-DCFPyL PET/CT Scan With Placebo Drink
- regimen
- 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.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03693742-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03693742
- outcome key
- om-0003
- arm key
- OG000
- arm label
- MSG Intervention
- regimen
- 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.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03693742-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03693742
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo Intervention
- regimen
- 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.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03693742-om-0003#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03693742
- harm key
- EG000
- source section id
- NCT03693742-ae
- event group key
- EG000
- event group label
- 18F-DCFPyL PET/CT Scan With MSG Drink
- serious affected
- 0
- serious at risk
- 10
- other affected
- 0
- other at risk
- 10
- frequency threshold
- 0
- collection period
- 24 hours
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-prostate-neoplasm
- nct id
- NCT03693742
- harm key
- EG001
- source section id
- NCT03693742-ae
- event group key
- EG001
- event group label
- 18F-DCFPyL PET/CT Scan With Placebo Drink
- serious affected
- 0
- serious at risk
- 10
- other affected
- 0
- other at risk
- 10
- frequency threshold
- 0
- collection period
- 24 hours
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice