Skip to content
← Full study record

NCT03693742 · ADVERSE EVENTS

Adverse events

MSG Use With 18F-DCFPyL PET/CT Imaging · Source last updated 2023-02-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
24 hours
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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.

0 / 100 / 100 / 10
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 / 100 / 100 / 10

Group identifiers: EG000: 18F-DCFPyL PET/CT Scan With MSG Drink · EG001: 18F-DCFPyL PET/CT Scan With Placebo Drink

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        10
        description
        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.
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        10
        serious Num Affected
        0
        serious Num At Risk
        10
        title
        18F-DCFPyL PET/CT Scan With MSG Drink
      2. deaths Num Affected
        0
        deaths Num At Risk
        10
        description
        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.
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        10
        serious Num Affected
        0
        serious Num At Risk
        10
        title
        18F-DCFPyL PET/CT Scan With Placebo Drink
      frequency Threshold
      0
      time Frame
      24 hours

      Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

      Preserved source evidence · Not medical advice