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NCT02981368 · OUTCOME

Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure)

Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer · Source last updated 2021-08-09

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
Changes in ECG pre-drug dosing and within 1-2 hours post-dosing

Analysis population: The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing ECG measurements).

Groups in this outcome

High Risk Prostate Cancer (Cohort A) - Baseline ECG

High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. Participants had a 12-lead electrocardiogram (ECG) taken on the day of dosing, prior to dosing.

High Risk Prostate Cancer (Cohort A) - Post-dosing ECG

High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. Participants had a 12-lead electrocardiogram (ECG) taken after dosing and prior to imaging.

Recurrent or Metastatic Prostate Cancer (Cohort B) - Baseline ECG

Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.

Recurrent or Metastatic Prostate Cancer (Cohort B) - Post-dosing ECG

Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. Participants had a 12-lead electrocardiogram (ECG) taken after dosing and prior to imaging.

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

Analysis denominator · Participants

GroupSource count
High Risk Prostate Cancer (Cohort A) - Baseline ECG260
High Risk Prostate Cancer (Cohort A) - Post-dosing ECG264
Recurrent or Metastatic Prostate Cancer (Cohort B) - Baseline ECG114
Recurrent or Metastatic Prostate Cancer (Cohort B) - Post-dosing ECG115

Reported measurements

Normal ECG Evaluation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
High Risk Prostate Cancer (Cohort A) - Baseline ECG159Not reportedNot reportedNot reportedNot reported
High Risk Prostate Cancer (Cohort A) - Post-dosing ECG155Not reportedNot reportedNot reportedNot reported
Recurrent or Metastatic Prostate Cancer (Cohort B) - Baseline ECG55Not reportedNot reportedNot reportedNot reported
Recurrent or Metastatic Prostate Cancer (Cohort B) - Post-dosing ECG51Not reportedNot reportedNot reportedNot reported
Abnormal ECG Evaluation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
High Risk Prostate Cancer (Cohort A) - Baseline ECG101Not reportedNot reportedNot reportedNot reported
High Risk Prostate Cancer (Cohort A) - Post-dosing ECG109Not reportedNot reportedNot reportedNot reported
Recurrent or Metastatic Prostate Cancer (Cohort B) - Baseline ECG59Not reportedNot reportedNot reportedNot reported
Recurrent or Metastatic Prostate Cancer (Cohort B) - Post-dosing ECG64Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        159
      2. group Id
        OG001
        value
        155
      3. group Id
        OG002
        value
        55
      4. group Id
        OG003
        value
        51
    title
    Normal ECG Evaluation
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        101
      2. group Id
        OG001
        value
        109
      3. group Id
        OG002
        value
        59
      4. group Id
        OG003
        value
        64
    title
    Abnormal ECG Evaluation
denoms
  1. counts
    1. group Id
      OG000
      value
      260
    2. group Id
      OG001
      value
      264
    3. group Id
      OG002
      value
      114
    4. group Id
      OG003
      value
      115
    units
    Participants
groups
  1. description
    High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. Participants had a 12-lead electrocardiogram (ECG) taken on the day of dosing, prior to dosing.
    id
    OG000
    title
    High Risk Prostate Cancer (Cohort A) - Baseline ECG
  2. description
    High risk prostate cancer participants planned for radical prostatectomy with pelvic lymph node dissection (Cohort A) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. Participants had a 12-lead electrocardiogram (ECG) taken after dosing and prior to imaging.
    id
    OG001
    title
    High Risk Prostate Cancer (Cohort A) - Post-dosing ECG
  3. description
    Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.
    id
    OG002
    title
    Recurrent or Metastatic Prostate Cancer (Cohort B) - Baseline ECG
  4. description
    Participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy (Cohort B) were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection. Participants had a 12-lead electrocardiogram (ECG) taken after dosing and prior to imaging.
    id
    OG003
    title
    Recurrent or Metastatic Prostate Cancer (Cohort B) - Post-dosing ECG
param Type
COUNT_OF_PARTICIPANTS
population Description
The Safety Set includes all participants who received any amount of 18F-DCFPyL and have reported data (i.e., some participants had missing ECG measurements).
reporting Status
POSTED
time Frame
Changes in ECG pre-drug dosing and within 1-2 hours post-dosing
title
Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice