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NCT02919111 · OUTCOME

Specificity of PSMA PET for the Detection of Osseous Metastases

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to 1 year

What was measured

68Ga-PSMA-11 positive bone lesions will be considered a True positive if there was a corresponding positive sclerotic lesion on the CT portion of the 68Ga-PSMA-11 PET in the same location as the PSMA uptake, If there is focal uptake seen in the same location as the PSMA uptake on the baseline bone scan performed within one month of 68Ga-PSMA-11 PET, if there is a lesion noted in the same location as the PSMA uptake on the initial MRI performed within one month of 68Ga-PSMA-11 PET, if within 12 months follow-up CT demonstrates development of sclerosis in the same location as the PSMA uptake, if within 12 months follow-up MRI demonstrates a new bone lesion in the same location as the PSMA uptake, if within 12 months follow-up bone scan demonstrates new focal uptake in the same location as the PSMA uptake and a False positive if 68Ga-PSMA-11 positive bone lesions do not meet the criteria for true positive findings.

Analysis population: Data on the detection of osseous metastases was not collected

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 PET0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
68Ga-PSMA-11 positive bone lesions will be considered a True positive if there was a corresponding positive sclerotic lesion on the CT portion of the 68Ga-PSMA-11 PET in the same location as the PSMA uptake, If there is focal uptake seen in the same location as the PSMA uptake on the baseline bone scan performed within one month of 68Ga-PSMA-11 PET, if there is a lesion noted in the same location as the PSMA uptake on the initial MRI performed within one month of 68Ga-PSMA-11 PET, if within 12 months follow-up CT demonstrates development of sclerosis in the same location as the PSMA uptake, if within 12 months follow-up MRI demonstrates a new bone lesion in the same location as the PSMA uptake, if within 12 months follow-up bone scan demonstrates new focal uptake in the same location as the PSMA uptake and a False positive if 68Ga-PSMA-11 positive bone lesions do not meet the criteria for true positive findings.
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
population Description
Data on the detection of osseous metastases was not collected
reporting Status
POSTED
time Frame
Up to 1 year
title
Specificity of PSMA PET for the Detection of Osseous Metastases
type
SECONDARY

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

Preserved source evidence · Not medical advice