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NCT03262389 · OUTCOME

Visual Image Analysis of Detected Multiple Myeloma Lesions

Comparison of F-18 FDG and C-11 Acetate PET in Multiple Myeloma · Source last updated 2021-03-16

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

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Approximately one month after Day 2

What was measured

The visual image analysis scale has a range of 0-4: (0 no uptake; 1 benign, 2 probably benign, 3 probably malignant, 4 malignant).

Analysis population: Each participant received both PET drugs by both diagnostic techniques (scans) and is therefore included in the analysis population for the four reporting groups.

Groups in this outcome

Multiple Myeloma (MM) Patients

New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups. Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi). Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq).

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

Analysis denominator · Participants

GroupSource count
Multiple Myeloma (MM) Patients7

Reported measurements

C-11 acetate PET CT
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM) Patients3.11.9Not reportedNot reportedNot reported
C-11 acetate PET MRI
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM) Patients3.31.8Not reportedNot reportedNot reported
18 FDG PET CT
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM) Patients1.92.0Not reportedNot reportedNot reported
18 FDG PET MRI
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM) Patients2.01.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.9
        value
        3.1
    title
    C-11 acetate PET CT
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.8
        value
        3.3
    title
    C-11 acetate PET MRI
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.0
        value
        1.9
    title
    18 FDG PET CT
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.9
        value
        2.0
    title
    18 FDG PET MRI
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
The visual image analysis scale has a range of 0-4: (0 no uptake; 1 benign, 2 probably benign, 3 probably malignant, 4 malignant).
dispersion Type
Standard Deviation
groups
  1. description
    New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups. Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi). Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq).
    id
    OG000
    title
    Multiple Myeloma (MM) Patients
param Type
MEAN
population Description
Each participant received both PET drugs by both diagnostic techniques (scans) and is therefore included in the analysis population for the four reporting groups.
reporting Status
POSTED
time Frame
Approximately one month after Day 2
title
Visual Image Analysis of Detected Multiple Myeloma Lesions
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice