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NCT02918357 · OUTCOME

Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation

Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence · Source last updated 2019-12-02

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

Measure
NUMBER
Unit
percentage of times value is true
Interval / dispersion
95% Confidence Interval
Time frame
1 month

What was measured

PPVs were calculated across the group on a per-region-basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% CIs. The CIs were constructed using the Wilson score method.

Analysis population: All subjects who received a 68Ga-PSMA-11 injection, had their 68Ga-PSMA-11 scan independently and blindly interpreted on a per region basis. Per region analyses included an evaluation of positive or negative for presence of PCa. Regional analyses included prostate bed, pelvic nodes, extrapelvic non-bone, and bone.

Groups in this outcome

Pet Positive (Per Region)

Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy

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

Analysis denominator · Participants

GroupSource count
Pet Positive (Per Region)120

Reported measurements

Source class 1
Values in percentage of times value is true · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pet Positive (Per Region)0.91Not reported0.850.95Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.85
        upper Limit
        0.95
        value
        0.91
denoms
  1. counts
    1. group Id
      OG000
      value
      120
    units
    Participants
description
PPVs were calculated across the group on a per-region-basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% CIs. The CIs were constructed using the Wilson score method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Evaluate the PPV on a per-patient basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy
    id
    OG000
    title
    Pet Positive (Per Region)
param Type
NUMBER
population Description
All subjects who received a 68Ga-PSMA-11 injection, had their 68Ga-PSMA-11 scan independently and blindly interpreted on a per region basis. Per region analyses included an evaluation of positive or negative for presence of PCa. Regional analyses included prostate bed, pelvic nodes, extrapelvic non-bone, and bone.
reporting Status
POSTED
time Frame
1 month
title
Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation
type
PRIMARY
unit Of Measure
percentage of times value is true

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

Preserved source evidence · Not medical advice