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NCT03724253 · OUTCOME

Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs

[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: %ID/g
Interval / dispersion: Not reported
Time frame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)

What was measured

For patients included in the dosimetry group, the percentage of injected dose per gram of tissue (%ID/g) reaching source organs was to be calculated using the acquired PET images at each time point. The resulting TACs were to be summarized descriptively.

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

Group	Source count
Breast	2

Reported measurements

Participant 1: 15 min post-dose (Bladder)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.03132	Not reported	Not reported	Not reported	Not reported

Participant 1: 15 min post-dose (Heart)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00600	Not reported	Not reported	Not reported	Not reported

Participant 1: 15 min post-dose (Kidney)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00688	Not reported	Not reported	Not reported	Not reported

Participant 1: 15 min post-dose (Liver)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00794	Not reported	Not reported	Not reported	Not reported

Participant 1: 15 min post-dose (Lung)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00218	Not reported	Not reported	Not reported	Not reported

Participant 1: 15 min post-dose (Marrow)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00331	Not reported	Not reported	Not reported	Not reported

Participant 1: 15 min post-dose (Pancreas)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.04711	Not reported	Not reported	Not reported	Not reported

Participant 1: 15 min post-dose (Spleen)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00409	Not reported	Not reported	Not reported	Not reported

Participant 1: 1 hour post-dose (Bladder)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.04259	Not reported	Not reported	Not reported	Not reported

Participant 1: 1 hour post-dose (Heart)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00241	Not reported	Not reported	Not reported	Not reported

Participant 1: 1 hour post-dose (Kidney)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00577	Not reported	Not reported	Not reported	Not reported

Participant 1: 1 hour post-dose (Liver)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00296	Not reported	Not reported	Not reported	Not reported

Participant 1: 1 hour post-dose (Lung)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00095	Not reported	Not reported	Not reported	Not reported

Participant 1: 1 hour post-dose (Marrow)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00116	Not reported	Not reported	Not reported	Not reported

Participant 1: 1 hour post-dose (Pancreas)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.04836	Not reported	Not reported	Not reported	Not reported

Participant 1: 1 hour post-dose (Spleen)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00211	Not reported	Not reported	Not reported	Not reported

Participant 1: 2 hours post-dose (Bladder)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.02141	Not reported	Not reported	Not reported	Not reported

Participant 1: 2 hours post-dose (Heart)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00163	Not reported	Not reported	Not reported	Not reported

Participant 1: 2 hours post-dose (Kidney)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00239	Not reported	Not reported	Not reported	Not reported

Participant 1: 2 hours post-dose (Liver)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00197	Not reported	Not reported	Not reported	Not reported

Participant 1: 2 hours post-dose (Lung)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00068	Not reported	Not reported	Not reported	Not reported

Participant 1: 2 hours post-dose (Marrow)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00092	Not reported	Not reported	Not reported	Not reported

Participant 1: 2 hours post-dose (Pancreas)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.05445	Not reported	Not reported	Not reported	Not reported

Participant 1: 2 hours post-dose (Spleen)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00141	Not reported	Not reported	Not reported	Not reported

Participant 1: 4 hours post-dose (Bladder)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.01790	Not reported	Not reported	Not reported	Not reported

Participant 1: 4 hours post-dose (Heart)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00130	Not reported	Not reported	Not reported	Not reported

Participant 1: 4 hours post-dose (Kidney)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00149	Not reported	Not reported	Not reported	Not reported

Participant 1: 4 hours post-dose (Liver)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00162	Not reported	Not reported	Not reported	Not reported

Participant 1: 4 hours post-dose (Lung)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00062	Not reported	Not reported	Not reported	Not reported

Participant 1: 4 hours post-dose (Marrow)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00035	Not reported	Not reported	Not reported	Not reported

Participant 1: 4 hours post-dose (Pancreas)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.06280	Not reported	Not reported	Not reported	Not reported

Participant 1: 4 hours post-dose (Spleen)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00120	Not reported	Not reported	Not reported	Not reported

Participant 2: 15 min post-dose (Bladder)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.02682	Not reported	Not reported	Not reported	Not reported

Participant 2: 15 min post-dose (Heart)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00340	Not reported	Not reported	Not reported	Not reported

Participant 2: 15 min post-dose (Kidney)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00480	Not reported	Not reported	Not reported	Not reported

Participant 2: 15 min post-dose (Liver)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00866	Not reported	Not reported	Not reported	Not reported

Participant 2: 15 min post-dose (Lung)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00124	Not reported	Not reported	Not reported	Not reported

Participant 2: 15 min post-dose (Marrow)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00186	Not reported	Not reported	Not reported	Not reported

Participant 2: 15 min post-dose (Pancreas)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.02146	Not reported	Not reported	Not reported	Not reported

Participant 2: 15 min post-dose (Spleen)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00338	Not reported	Not reported	Not reported	Not reported

Participant 2: 1 hour post-dose (Bladder)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.06480	Not reported	Not reported	Not reported	Not reported

Participant 2: 1 hour post-dose (Heart)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00207	Not reported	Not reported	Not reported	Not reported

Participant 2: 1 hour post-dose (Kidney)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00380	Not reported	Not reported	Not reported	Not reported

Participant 2: 1 hour post-dose (Liver)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00564	Not reported	Not reported	Not reported	Not reported

Participant 2: 1 hour post-dose (Lung)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00088	Not reported	Not reported	Not reported	Not reported

Participant 2: 1 hour post-dose (Marrow)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00136	Not reported	Not reported	Not reported	Not reported

Participant 2: 1 hour post-dose (Pancreas)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.02909	Not reported	Not reported	Not reported	Not reported

Participant 2: 1 hour post-dose (Spleen)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00256	Not reported	Not reported	Not reported	Not reported

Participant 2: 2 hours post-dose (Bladder)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.04055	Not reported	Not reported	Not reported	Not reported

Participant 2: 2 hours post-dose (Heart)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00142	Not reported	Not reported	Not reported	Not reported

Participant 2: 2 hours post-dose (Kidney)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00505	Not reported	Not reported	Not reported	Not reported

Participant 2: 2 hours post-dose (Liver)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00428	Not reported	Not reported	Not reported	Not reported

Participant 2: 2 hours post-dose (Lung)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00059	Not reported	Not reported	Not reported	Not reported

Participant 2: 2 hours post-dose (Marrow)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00100	Not reported	Not reported	Not reported	Not reported

Participant 2: 2 hours post-dose (Pancreas)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.03450	Not reported	Not reported	Not reported	Not reported

Participant 2: 2 hours post-dose (Spleen)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00191	Not reported	Not reported	Not reported	Not reported

Participant 2: 4 hours post-dose (Bladder)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.11045	Not reported	Not reported	Not reported	Not reported

Participant 2: 4 hours post-dose (Heart)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00093	Not reported	Not reported	Not reported	Not reported

Participant 2: 4 hours post-dose (Kidney)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00278	Not reported	Not reported	Not reported	Not reported

Participant 2: 4 hours post-dose (Liver)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00317	Not reported	Not reported	Not reported	Not reported

Participant 2: 4 hours post-dose (Lung)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00039	Not reported	Not reported	Not reported	Not reported

Participant 2: 4 hours post-dose (Marrow)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00072	Not reported	Not reported	Not reported	Not reported

Participant 2: 4 hours post-dose (Pancreas)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.03745	Not reported	Not reported	Not reported	Not reported

Participant 2: 4 hours post-dose (Spleen)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00145	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0.03132
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 15 min post-dose (Bladder)
categories
measurements
group Id
OG000
value
0.00600
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 15 min post-dose (Heart)
categories
measurements
group Id
OG000
value
0.00688
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 15 min post-dose (Kidney)
categories
measurements
group Id
OG000
value
0.00794
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 15 min post-dose (Liver)
categories
measurements
group Id
OG000
value
0.00218
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 15 min post-dose (Lung)
categories
measurements
group Id
OG000
value
0.00331
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 15 min post-dose (Marrow)
categories
measurements
group Id
OG000
value
0.04711
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 15 min post-dose (Pancreas)
categories
measurements
group Id
OG000
value
0.00409
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 15 min post-dose (Spleen)
categories
measurements
group Id
OG000
value
0.04259
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 1 hour post-dose (Bladder)
categories
measurements
group Id
OG000
value
0.00241
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 1 hour post-dose (Heart)
categories
measurements
group Id
OG000
value
0.00577
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 1 hour post-dose (Kidney)
categories
measurements
group Id
OG000
value
0.00296
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 1 hour post-dose (Liver)

denoms

counts
group Id
OG000
value
2
units
Participants

description

For patients included in the dosimetry group, the percentage of injected dose per gram of tissue (%ID/g) reaching source organs was to be calculated using the acquired PET images at each time point. The resulting TACs were to be summarized descriptively.

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

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 (0.15, 1.00, 2.00 and 4.00 hours)

title

Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs

type

PRIMARY

unit Of Measure

%ID/g

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

Preserved source evidence · Not medical advice