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NCT04186845 · OUTCOME

Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers

Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence · Source last updated 2025-09-22

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

Measure
NUMBER
Unit
percentage
Interval / dispersion
95% Confidence Interval
Time frame
PET Scan on Day 1

What was measured

The Cohen's kappa statistic will be calculated to assess pairwise agreement between any 2 blinded independent readers

Analysis population: Evaluable PET Scan Population (EPSP): All patients who received the rhPSMA-7.3 (18F) injection with a PET scan.

Groups in this outcome

Patient-level Inter-reader Reproducibility

Patient-level Inter-reader Reproducibility for Evaluable PET Scan Population (EPSP)

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

Analysis denominator · Participants

GroupSource count
Patient-level Inter-reader Reproducibility389

Reported measurements

Central Reader 1 vs Reader 2
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Patient-level Inter-reader Reproducibility0.29Not reported0.210.38Not reported
Central Reader 1 vs Reader 3
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Patient-level Inter-reader Reproducibility0.38Not reported0.250.51Not reported
Central Reader 2 vs Reader 3
Values in percentage · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Patient-level Inter-reader Reproducibility0.50Not reported0.410.60Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.21
        upper Limit
        0.38
        value
        0.29
    title
    Central Reader 1 vs Reader 2
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.25
        upper Limit
        0.51
        value
        0.38
    title
    Central Reader 1 vs Reader 3
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.41
        upper Limit
        0.60
        value
        0.50
    title
    Central Reader 2 vs Reader 3
denoms
  1. counts
    1. group Id
      OG000
      value
      389
    units
    Participants
description
The Cohen's kappa statistic will be calculated to assess pairwise agreement between any 2 blinded independent readers
dispersion Type
95% Confidence Interval
groups
  1. description
    Patient-level Inter-reader Reproducibility for Evaluable PET Scan Population (EPSP)
    id
    OG000
    title
    Patient-level Inter-reader Reproducibility
param Type
NUMBER
population Description
Evaluable PET Scan Population (EPSP): All patients who received the rhPSMA-7.3 (18F) injection with a PET scan.
reporting Status
POSTED
time Frame
PET Scan on Day 1
title
Reader Kappa Statistics of rhPSMA7.3 (18F) Scan Interpretation by the Blinded Independent Readers
type
SECONDARY
unit Of Measure
percentage

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice