NCT03724253 · OUTCOME

Dosimetry Group: Urinary Excretion of [68Ga]-NeoBOMB1 (Vd)

[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: MEAN
Unit: L
Interval / dispersion: Standard Deviation
Time frame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

What was measured

Urine samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. Vd 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. As the total volume of excreted urine was not recorded, no percentage of urinary excretion could be calculated.

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

Group	Source count
Breast	2

Reported measurements

Source class 1

Values in L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Breast	NA	NA	Not reported	Not reported	NA: total volume of excreted urine was not recorded. Thus, no % of urinary excretion could be calculated.

Complete source fields

classes

categories
measurements
comment
NA: total volume of excreted urine was not recorded. Thus, no % of urinary excretion could be calculated.
group Id
OG000
spread
NA
value
NA

denoms

counts
group Id
OG000
value
2
units
Participants

description

Urine samples were collected for activity-based pharmacokinetics characterization in the dosimetry group. Vd was to be listed and summarized using descriptive statistics.

dispersion Type

Standard Deviation

groups

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

MEAN

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. As the total volume of excreted urine was not recorded, no percentage of urinary excretion could be calculated.

reporting Status

POSTED

time Frame

[68Ga]-NeoBOMB1 PET imaging acquired at Day 1

title

Dosimetry Group: Urinary Excretion of [68Ga]-NeoBOMB1 (Vd)

type

SECONDARY

unit Of Measure

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

Preserved source evidence · Not medical advice