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NCT03724253 · OUTCOME

Dosimetry Group: Time of Maximum Observed Drug Concentration Occurrence (Tmax)

[68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR) · Source last updated 2020-10-23

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

Measure
NUMBER
Unit
min
Interval / dispersion
Not reported
Time frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1

What was measured

Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. Tmax was to be listed and summarized using descriptive statistics.

Analysis population: Full Analysis Set (FAS). Dosimetry group targeted participants with Breast Cancer and Prostate Cancer, but only 2 participants from Breast Cancer arm enrolled in the Dosimetry Group. Due to the sample size in the dosimetry group (2 patients), summary statistics were not performed.

Groups in this outcome

Breast

All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].

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

Analysis denominator · Participants

GroupSource count
Breast2

Reported measurements

Participant 1

Analysis denominator · Participants

GroupSource count
Breast1
Values in min · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast5.78Not reportedNot reportedNot reportedNot reported
Participant 2

Analysis denominator · Participants

GroupSource count
Breast1
Values in min · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast5.73Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5.78
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Participant 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5.73
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Participant 2
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
Venous whole blood samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. Tmax was to be listed and summarized using descriptive statistics.
groups
  1. description
    All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
    id
    OG000
    title
    Breast
param Type
NUMBER
population Description
Full Analysis Set (FAS). Dosimetry group targeted participants with Breast Cancer and Prostate Cancer, but only 2 participants from Breast Cancer arm enrolled in the Dosimetry Group. Due to the sample size in the dosimetry group (2 patients), summary statistics were not performed.
reporting Status
POSTED
time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
title
Dosimetry Group: Time of Maximum Observed Drug Concentration Occurrence (Tmax)
type
SECONDARY
unit Of Measure
min

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice