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NCT03724253 · OUTCOME

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

[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 tumor lesions 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 (T1 Chest)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00347	Not reported	Not reported	Not reported	Not reported

Participant 1: 15 min post-dose (T2 Left rib)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00384	Not reported	Not reported	Not reported	Not reported

Participant 1: 15 min post-dose (T3 Spine)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00469	Not reported	Not reported	Not reported	Not reported

Participant 1: 1 hour post-dose (T1 Chest)

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: 1 hour post-dose (T2 Left rib)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00251	Not reported	Not reported	Not reported	Not reported

Participant 1: 1 hour post-dose (T3 Spine)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00225	Not reported	Not reported	Not reported	Not reported

Participant 1: 2 hours post-dose (T1 Chest)

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: 2 hours post-dose (T2 Left rib)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00173	Not reported	Not reported	Not reported	Not reported

Participant 1: 2 hours post-dose (T3 Spine)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00185	Not reported	Not reported	Not reported	Not reported

Participant 1: 4 hours post-dose (T1 Chest)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00129	Not reported	Not reported	Not reported	Not reported

Participant 1: 4 hours post-dose (T2 Left rib)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00167	Not reported	Not reported	Not reported	Not reported

Participant 1: 4 hours post-dose (T3 Spine)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00195	Not reported	Not reported	Not reported	Not reported

Participant 2: 15 min post-dose (T1 lungL)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00367	Not reported	Not reported	Not reported	Not reported

Participant 2: 15 min post-dose (T2 lungR)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00466	Not reported	Not reported	Not reported	Not reported

Participant 2: 15 min post-dose (T3 liverL)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.01353	Not reported	Not reported	Not reported	Not reported

Participant 2: 15 min post-dose (T4 liverR1)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.01304	Not reported	Not reported	Not reported	Not reported

Participant 2: 15 min post-dose (T5 liverR2)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.01504	Not reported	Not reported	Not reported	Not reported

Participant 2: 15 min post-dose (T6 sacrumL)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00315	Not reported	Not reported	Not reported	Not reported

Participant 2: 15 min post-dose (T7 liverP)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.01218	Not reported	Not reported	Not reported	Not reported

Participant 2: 15 min post-dose (T8 liverR)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.01079	Not reported	Not reported	Not reported	Not reported

Participant 2: 1 hour post-dose (T1 lungL)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00455	Not reported	Not reported	Not reported	Not reported

Participant 2: 1 hour post-dose (T2 lungR)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00463	Not reported	Not reported	Not reported	Not reported

Participant 2: 1 hour post-dose (T3 liverL)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.01800	Not reported	Not reported	Not reported	Not reported

Participant 2: 1 hour post-dose (T4 liverR1)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.01400	Not reported	Not reported	Not reported	Not reported

Participant 2: 1 hour post-dose (T5 liverR2)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.01928	Not reported	Not reported	Not reported	Not reported

Participant 2: 1 hour post-dose (T6 sacrumL)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00289	Not reported	Not reported	Not reported	Not reported

Participant 2: 1 hour post-dose (T7 liverP)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.01180	Not reported	Not reported	Not reported	Not reported

Participant 2: 1 hour post-dose (T8 liverR)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00961	Not reported	Not reported	Not reported	Not reported

Participant 2: 2 hours post-dose (T1 lungL)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00481	Not reported	Not reported	Not reported	Not reported

Participant 2: 2 hours post-dose (T2 lungR)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00377	Not reported	Not reported	Not reported	Not reported

Participant 2: 2 hours post-dose (T3 liverL)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00984	Not reported	Not reported	Not reported	Not reported

Participant 2: 2 hours post-dose (T4 liverR1)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.01527	Not reported	Not reported	Not reported	Not reported

Participant 2: 2 hours post-dose (T5 liverR2)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.02197	Not reported	Not reported	Not reported	Not reported

Participant 2: 2 hours post-dose (T6 sacrumL)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00254	Not reported	Not reported	Not reported	Not reported

Participant 2: 2 hours post-dose (T7 liverP)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.01242	Not reported	Not reported	Not reported	Not reported

Participant 2: 2 hours post-dose (T8 liverR)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.01088	Not reported	Not reported	Not reported	Not reported

Participant 2: 4 hours post-dose (T1 lungL)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00385	Not reported	Not reported	Not reported	Not reported

articipant 2: 4 hours post-dose (T2 lungR)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00248	Not reported	Not reported	Not reported	Not reported

Participant 2: 4 hours post-dose (T3 liverL)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.01782	Not reported	Not reported	Not reported	Not reported

Participant 2: 4 hours post-dose (T4 liverR1)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.01164	Not reported	Not reported	Not reported	Not reported

Participant 2: 4 hours post-dose (T5 liverR2)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.02119	Not reported	Not reported	Not reported	Not reported

Participant 2: 4 hours post-dose (T6 sacrumL)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.00188	Not reported	Not reported	Not reported	Not reported

Participant 2: 4 hours post-dose (T7 liverP)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.01082	Not reported	Not reported	Not reported	Not reported

Participant 2: 4 hours post-dose (T8 liverR)

Analysis denominator · Participants

Group	Source count
Breast	1

Values in %ID/g · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Breast	0.01012	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0.00347
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 15 min post-dose (T1 Chest)
categories
measurements
group Id
OG000
value
0.00384
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 15 min post-dose (T2 Left rib)
categories
measurements
group Id
OG000
value
0.00469
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 15 min post-dose (T3 Spine)
categories
measurements
group Id
OG000
value
0.00218
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 1 hour post-dose (T1 Chest)
categories
measurements
group Id
OG000
value
0.00251
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 1 hour post-dose (T2 Left rib)
categories
measurements
group Id
OG000
value
0.00225
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 1 hour post-dose (T3 Spine)
categories
measurements
group Id
OG000
value
0.00149
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 2 hours post-dose (T1 Chest)
categories
measurements
group Id
OG000
value
0.00173
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 2 hours post-dose (T2 Left rib)
categories
measurements
group Id
OG000
value
0.00185
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 2 hours post-dose (T3 Spine)
categories
measurements
group Id
OG000
value
0.00129
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 4 hours post-dose (T1 Chest)
categories
measurements
group Id
OG000
value
0.00167
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 4 hours post-dose (T2 Left rib)
categories
measurements
group Id
OG000
value
0.00195
denoms
counts
group Id
OG000
value
1
units
Participants
title
Participant 1: 4 hours post-dose (T3 Spine)

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 tumor lesions 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 Tumors

type

PRIMARY

unit Of Measure

%ID/g

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

Preserved source evidence · Not medical advice