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NCT03739684 · OUTCOME

Collection of Medical Procedures (Safety Outcome Measure)

Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer · Source last updated 2021-06-14

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.

What was measured

Procedures will be coded using the same version of MedDRA as for medical history. Medical procedures will be displayed as a listing by participant.

Analysis population: The Safety Set includes all participants who received any amount of 18F-DCFPyL.

Groups in this outcome

18F-DCFPyL Injection

Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.

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

Analysis denominator · Participants

GroupSource count
18F-DCFPyL Injection208

Reported measurements

Biopsy testes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection1Not reportedNot reportedNot reportedNot reported
Computerized tomogram
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection1Not reportedNot reportedNot reportedNot reported
Nuclear magnetic resonance imaging
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection1Not reportedNot reportedNot reportedNot reported
Ultrasound testes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection1Not reportedNot reportedNot reportedNot reported
Open reduction of fracture
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection1Not reportedNot reportedNot reportedNot reported
Orchidectomy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
18F-DCFPyL Injection1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Biopsy testes
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Computerized tomogram
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Nuclear magnetic resonance imaging
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Ultrasound testes
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Open reduction of fracture
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Orchidectomy
denoms
  1. counts
    1. group Id
      OG000
      value
      208
    units
    Participants
description
Procedures will be coded using the same version of MedDRA as for medical history. Medical procedures will be displayed as a listing by participant.
groups
  1. description
    Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.
    id
    OG000
    title
    18F-DCFPyL Injection
param Type
COUNT_OF_PARTICIPANTS
population Description
The Safety Set includes all participants who received any amount of 18F-DCFPyL.
reporting Status
POSTED
time Frame
From the time of 18F-DCFPyL dosing to completion of the follow-up visit at 7 (±3) days after 18F-DCFPyL dosing.
title
Collection of Medical Procedures (Safety Outcome Measure)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice