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NCT03262389 · OUTCOME

Mean Multiple Myeloma Lesions Detected

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
number of lesions
Interval / dispersion
Standard Deviation
Time frame
Day 1, Day 2

What was measured

The number of lesions detected in the scans will be averaged for each technique. Two techniques (scans) will be tested on Day 1 and two techniques (scans) will be tested on Day 2.

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 number of lesions · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM) Patients4.65.1Not reportedNot reportedNot reported
C-11 acetate PET MRI
Values in number of lesions · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM) Patients4.45.2Not reportedNot reportedNot reported
18 FDG PET CT
Values in number of lesions · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM) Patients1.11.7Not reportedNot reportedNot reported
18 FDG PET MRI
Values in number of lesions · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM) Patients1.01.8Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.1
        value
        4.6
    title
    C-11 acetate PET CT
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.2
        value
        4.4
    title
    C-11 acetate PET MRI
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.7
        value
        1.1
    title
    18 FDG PET CT
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.8
        value
        1.0
    title
    18 FDG PET MRI
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
The number of lesions detected in the scans will be averaged for each technique. Two techniques (scans) will be tested on Day 1 and two techniques (scans) will be tested on Day 2.
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
Day 1, Day 2
title
Mean Multiple Myeloma Lesions Detected
type
PRIMARY
unit Of Measure
number of lesions

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

Preserved source evidence · Not medical advice