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NCT02919111 · OUTCOME

Positive Predictive Value (PPV) of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy

Gallium-68 PSMA-11 PET in Intermediate to High-risk Preprostatectomy Patients · Source last updated 2020-12-10

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

Measure
NUMBER
Unit
proportion of true positives
Interval / dispersion
Not reported
Time frame
Up to 1 year

What was measured

PPV is the proportion of patients with positive test who actually have the disease. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true-negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for up to one year can be used in analysis

Groups in this outcome

Ga-68 Labeled PSMA-11 PET

PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

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

Analysis denominator · Participants

GroupSource count
Ga-68 Labeled PSMA-11 PET299

Reported measurements

Source class 1
Values in proportion of true positives · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ga-68 Labeled PSMA-11 PET.64Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        .64
denoms
  1. counts
    1. group Id
      OG000
      value
      299
    units
    Participants
description
PPV is the proportion of patients with positive test who actually have the disease. Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true-negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Follow-up scans for up to one year can be used in analysis
groups
  1. description
    PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later. Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
    id
    OG000
    title
    Ga-68 Labeled PSMA-11 PET
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 1 year
title
Positive Predictive Value (PPV) of of PSMA PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
type
PRIMARY
unit Of Measure
proportion of true positives

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

Preserved source evidence · Not medical advice