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NCT02175745 · OUTCOME

Percent Agreement of 18F FDOPA PET With Pathology

18F-FDOPA PET/CT or PET/MRI in Measuring Tumors in Patients With Newly-Diagnosed or Recurrent Gliomas · Source last updated 2017-03-20

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

Measure
NUMBER
Unit
percentage of agreement (sensitivity)
Interval / dispersion
Not reported
Time frame
Up to 30 minutes post-injection (at time of scan)

What was measured

For the subset of lesions where pathology is available (mainly biopsied lesions), the accuracy of 18F FDOPA PET as percent agreement with pathology will be calculated. If the number of biopsy positive lesions is at least 10, an estimate of sensitivity will be calculate; if the number of biopsy negative lesions is at least 10 an estimate of specificity will be calculated.

Groups in this outcome

Diagnostic (FDOPA-PET/CT or PET/MRI)

Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.

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

Analysis denominator · Participants

GroupSource count
Diagnostic (FDOPA-PET/CT or PET/MRI)1

Reported measurements

Source class 1
Values in percentage of agreement (sensitivity) · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Diagnostic (FDOPA-PET/CT or PET/MRI)100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
For the subset of lesions where pathology is available (mainly biopsied lesions), the accuracy of 18F FDOPA PET as percent agreement with pathology will be calculated. If the number of biopsy positive lesions is at least 10, an estimate of sensitivity will be calculate; if the number of biopsy negative lesions is at least 10 an estimate of specificity will be calculated.
groups
  1. description
    Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
    id
    OG000
    title
    Diagnostic (FDOPA-PET/CT or PET/MRI)
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 30 minutes post-injection (at time of scan)
title
Percent Agreement of 18F FDOPA PET With Pathology
type
PRIMARY
unit Of Measure
percentage of agreement (sensitivity)

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

Preserved source evidence · Not medical advice