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18F-DCFPyL is an agent that binds to prostate specific membrane antigen (PSMA). Due to high levels of PSMA in prostate cancer, treatments targeting PSMA have been developed to deliver therapy to these specific target cells. Unfortunately when this treatment is delivered there is radiotracer uptake in the salivary glands and kidneys, not related to cancer, which causes dry mouth and causes patients to stop treatment. It is proposed that having tomato juice containing monosodium glutamate (MSG) may reduce radiotracer uptake in the salivary glands and kidneys and reduce damage to these tissues.
This is a prospective single cohort study to evaluate the utility of MSG in reducing salivary gland radiotracer uptake, in patients who undergo an 18F-DCFPyL Positron Emission tomography / Computer Tomography (PET/CT) scan.
18F-DCFPyL PET/CT scans Each participant will receive 2 18F-DCFPyL PET/CT scans at the BC Cancer - Vancouver Centre, as part of this research sub-study. Each participant will receive tomato juice before each appointment. One visit they will have tomato juice containing MSG and the other will be a placebo (standard tomato juice).
Each study participant will receive a bolus intravenous dose of 18F-DCFPyL. The participant will rest in a comfortable chair for 120 minutes and will then be taken to the PET/CT scanner for images.
24 hour follow-up All participants will be requested to either return to the functional imaging department approximately 24 hours (acceptable range 16-28 hours) after the injection of 18F-DCFPyL and tomato juice consumption or agree to be contacted by phone. The participants will be asked if they experienced any undesirable effects following the administration of 18F-DCFPyL and tomato juice, or in the intervening 24 hours. The local site attending nuclear medicine physician will then make an assessment as to whether these effects are likely related to 18F-DCFPyL and/or tomato juice administration.
The study is expected to take approximately 1 year for accrual.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-DCFPyL PET/CT scan with MSG drink | Experimental | Food grade MSG will be dissolved in low sodium tomato juice, and administered orally before 18F-DCFPyL administration. |
|
| 18F-DCFPyL PET/CT scan with placebo drink | Placebo Comparator | Regular tomato juice will be used, and administered orally before 18F-DCFPyL administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-DCFPyL PET/CT scan | Diagnostic Test | Participants will have their weight recorded and baseline vital signs (blood pressure, heart rate, and oxygen saturation level) measured prior to the tomato juice ingestion, immediately prior to 18F-DCFPyL injection and 5 to 15 minutes after injection. The participant will receive a bolus intravenous dose of 18F-DCFPyL. After 60 min, the vital signs will be recorded and again two hours after 18F-DCFPyL. Immediately before scanning, the participants will be taken to a designated washroom and asked to void. The PET/CT image acquisition time will be approximately 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary Gland Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL | 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. | scan with MSG and 3-7 days later, scan with Placebo (or vice versa) |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francois Benard, MD | BC Cancer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer | Vancouver | British Columbia | V5Z 4E6 | Canada |
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| Label | URL |
|---|---|
| The effects of monosodium glutamate on PSMA radiotracer uptake in men with recurrent prostate cancer: a prospective, randomized, double-blind, placebo-controlled intra-individual imaging study. | View source |
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10 of 10 participants were randomized.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Salivary Gland Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL | 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. | All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis. | Posted | Mean | Standard Deviation | SULmax | scan with MSG and 3-7 days later, scan with Placebo (or vice versa) |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 18F-DCFPyL PET/CT Scan With MSG Drink | Food grade MSG will be dissolved in low sodium tomato juice, and administered orally before 18F-DCFPyL administration. 18F-DCFPyL PET/CT scan: Participants will have their weight recorded and baseline vital signs (blood pressure, heart rate, and oxygen saturation level) measured prior to the tomato juice ingestion, immediately prior to 18F-DCFPyL injection and 5 to 15 minutes after injection. The participant will receive a bolus intravenous dose of 18F-DCFPyL. After 60 min, the vital signs will be recorded and again two hours after 18F-DCFPyL. Immediately before scanning, the participants will be taken to a designated washroom and asked to void. The PET/CT image acquisition time will be approximately 30 minutes. MSG drink: Participants will consume 300mL of tomato juice with MSG 30 minutes prior to 18F-DCFPyL injection. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Manager | BC Cancer - Vancouver | (604) 877-6000, | hsaprunoff@bccancer.bc.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2018 | Oct 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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This is a prospective double blind intra-participant comparison of [18F]-DCFPyL PET/CT scans performed after orally administered MSG or placebo. The participants will receive oral administration of MSG or placebo, in two different examination sessions, 30 minutes before [18F]-DCFPyL injection.
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For randomization, a computer generated random list will determine the order of the scans (MSG first, placebo first). Sealed envelopes will be prepared. A study coordinator or technologist not involved in measuring vital signs or collecting adverse events will prepare the tomato juice solution based on the randomization envelope. The rest of the team will not be informed of which tomato juice is used (placebo or MSG) but this information will be recorded and will be immediately accessible should a participant experience a severe adverse event.
|
| Placebo drink | Other | Participants will consume 300mL of tomato juice 30 minutes prior to 18F-DCFPyL injection. |
|
| MSG drink | Other | Participants will consume 300mL of tomato juice with MSG 30 minutes prior to 18F-DCFPyL injection. |
|
| scan with MSG and 3-7 days later, scan with Placebo (or vice versa) |
| Tumour Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL | 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. | scan with MSG and 3-7 days later, scan with Placebo (or vice versa) |
| Number of Participants With Tomato Juice (Containing Either MSG or Placebo) Related Adverse Events as Assessed by Abnormal Vital Sign Measurement. | 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. | 2 hours |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| Secondary | Renal Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL | 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. | All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis. | Posted | Mean | Standard Deviation | SULmax | scan with MSG and 3-7 days later, scan with Placebo (or vice versa) |
|
|
|
| Secondary | Tumour Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL | 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. | All participants who received at least one dose of each intervention and completed all study visits were included in the efficacy analysis. | Posted | Median | Full Range | SULmax | scan with MSG and 3-7 days later, scan with Placebo (or vice versa) | malignant lesions | malignant lesions |
|
|
|
| Secondary | Number of Participants With Tomato Juice (Containing Either MSG or Placebo) Related Adverse Events as Assessed by Abnormal Vital Sign Measurement. | 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. | Posted | Count of Participants | Participants | 2 hours |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 18F-DCFPyL PET/CT Scan With Placebo Drink | Regular tomato juice will be used, and administered orally before 18F-DCFPyL administration. 18F-DCFPyL PET/CT scan: Participants will have their weight recorded and baseline vital signs (blood pressure, heart rate, and oxygen saturation level) measured prior to the tomato juice ingestion, immediately prior to 18F-DCFPyL injection and 5 to 15 minutes after injection. The participant will receive a bolus intravenous dose of 18F-DCFPyL. After 60 min, the vital signs will be recorded and again two hours after 18F-DCFPyL. Immediately before scanning, the participants will be taken to a designated washroom and asked to void. The PET/CT image acquisition time will be approximately 30 minutes. Placebo drink: Participants will consume 300mL of tomato juice 30 minutes prior to 18F-DCFPyL injection. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |