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NCT03693742 · OUTCOME

Renal Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL

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.

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 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.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
18F-DCFPyL PET/CT Scan With MSG Drink10
18F-DCFPyL PET/CT Scan With Placebo Drink10

Reported measurements

Source class 1
Values in SULmax · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
18F-DCFPyL PET/CT Scan With MSG Drink27.48.0Not reportedNot reportedNot reported
18F-DCFPyL PET/CT Scan With Placebo Drink37.59.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.0
        value
        27.4
      2. group Id
        OG001
        spread
        9.6
        value
        37.5
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      10
    units
    Participants
description
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.
dispersion Type
Standard Deviation
groups
  1. 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
  2. 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
Renal Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL
type
SECONDARY
unit Of Measure
SULmax

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

Preserved source evidence · Not medical advice