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NCT03724253 · OUTCOME

Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location

[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: Standard Uptake Value (SUV)
Interval / dispersion: Standard Deviation
Time frame: [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)

What was measured

Targeting properties of \[68Ga\]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.

Analysis population: Full Analysis Set (FAS). The results of the biopsied samples for all patients were positive for GRPR and thus the presentation of results according to GRPR expression were no longer suitable.

Groups in this outcome

Breast

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

Prostate

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

Colorectal

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

Non-Small Cell Lung Cancer (NSCLC)

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

Small-Cell Lung Cancer (SCLC)

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	5
Prostate	5
Colorectal	5
Non-Small Cell Lung Cancer (NSCLC)	3
Small-Cell Lung Cancer (SCLC)	1

Reported measurements

SUV max:Overall (0.05 hours)

Analysis denominator · Participants

Group	Source count
Breast	0
Prostate	5
Colorectal	0
Non-Small Cell Lung Cancer (NSCLC)	0
Small-Cell Lung Cancer (SCLC)	0

Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Prostate	2.166	1.1164	Not reported	Not reported	Not reported

SUV max:Nodal (0.05 hours)

Analysis denominator · Participants

Group	Source count
Breast	0
Prostate	1
Colorectal	0
Non-Small Cell Lung Cancer (NSCLC)	0
Small-Cell Lung Cancer (SCLC)	0

Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Prostate	0.880	NA	Not reported	Not reported	Only one participant analyzed

SUV max:Skeletal (0.05 hours)

Analysis denominator · Participants

Group	Source count
Breast	0
Prostate	1
Colorectal	0
Non-Small Cell Lung Cancer (NSCLC)	0
Small-Cell Lung Cancer (SCLC)	0

Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Prostate	2.480	NA	Not reported	Not reported	Only one participant analyzed

SUV max:Skin/Superficial (0.05 hours)

Analysis denominator · Participants

Group	Source count
Breast	0
Prostate	0
Colorectal	0
Non-Small Cell Lung Cancer (NSCLC)	0
Small-Cell Lung Cancer (SCLC)	0

SUV max:Soft Tissue/Visceral (0.05 hours)

Analysis denominator · Participants

Group	Source count
Breast	0
Prostate	4
Colorectal	0
Non-Small Cell Lung Cancer (NSCLC)	0
Small-Cell Lung Cancer (SCLC)	0

Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Prostate	2.088	1.2731	Not reported	Not reported	Not reported

SUV max:Overall (1.50 hours)

Analysis denominator · Participants

Group	Source count
Breast	3
Prostate	5
Colorectal	5
Non-Small Cell Lung Cancer (NSCLC)	3
Small-Cell Lung Cancer (SCLC)	1

Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Breast	19.040	17.5106	Not reported	Not reported	Not reported
Prostate	17.326	24.2165	Not reported	Not reported	Not reported
Colorectal	3.570	0.7504	Not reported	Not reported	Not reported
Non-Small Cell Lung Cancer (NSCLC)	2.097	0.6863	Not reported	Not reported	Not reported
Small-Cell Lung Cancer (SCLC)	1.810	NA	Not reported	Not reported	Only one participant analyzed

SUV max:Nodal (1.50 hours)

Analysis denominator · Participants

Group	Source count
Breast	2
Prostate	2
Colorectal	2
Non-Small Cell Lung Cancer (NSCLC)	3
Small-Cell Lung Cancer (SCLC)	1

Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Breast	9.070	11.3986	Not reported	Not reported	Not reported
Prostate	1.505	0.4313	Not reported	Not reported	Not reported
Colorectal	2.090	0.5233	Not reported	Not reported	Not reported
Non-Small Cell Lung Cancer (NSCLC)	1.917	0.7139	Not reported	Not reported	Not reported
Small-Cell Lung Cancer (SCLC)	1.450	NA	Not reported	Not reported	Only one participant analyzed

SUV max:Skeletal (1.50 hours)

Analysis denominator · Participants

Group	Source count
Breast	2
Prostate	2
Colorectal	0
Non-Small Cell Lung Cancer (NSCLC)	0
Small-Cell Lung Cancer (SCLC)	0

Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Breast	10.325	13.0461	Not reported	Not reported	Not reported
Prostate	2.135	0.9687	Not reported	Not reported	Not reported

SUV max:Skin/Superficial (1.50 hours)

Analysis denominator · Participants

Group	Source count
Breast	1
Prostate	0
Colorectal	1
Non-Small Cell Lung Cancer (NSCLC)	0
Small-Cell Lung Cancer (SCLC)	0

Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Breast	7.400	NA	Not reported	Not reported	Only one participant analyzed
Colorectal	0.750	NA	Not reported	Not reported	Only one participant analyzed

SUV max:Soft Tissue/Visceral (1.50 hours)

Analysis denominator · Participants

Group	Source count
Breast	3
Prostate	4
Colorectal	5
Non-Small Cell Lung Cancer (NSCLC)	3
Small-Cell Lung Cancer (SCLC)	1

Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Breast	18.580	17.5086	Not reported	Not reported	Not reported
Prostate	20.953	26.3485	Not reported	Not reported	Not reported
Colorectal	3.570	0.7504	Not reported	Not reported	Not reported
Non-Small Cell Lung Cancer (NSCLC)	2.097	0.6863	Not reported	Not reported	Not reported
Small-Cell Lung Cancer (SCLC)	1.810	NA	Not reported	Not reported	Only one participant analyzed

SUV max:Overall (2.50 hours)

Analysis denominator · Participants

Group	Source count
Breast	3
Prostate	5
Colorectal	5
Non-Small Cell Lung Cancer (NSCLC)	3
Small-Cell Lung Cancer (SCLC)	1

Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Breast	23.120	19.7908	Not reported	Not reported	Not reported
Prostate	14.544	18.4921	Not reported	Not reported	Not reported
Colorectal	2.890	0.5866	Not reported	Not reported	Not reported
Non-Small Cell Lung Cancer (NSCLC)	2.050	0.8314	Not reported	Not reported	Not reported
Small-Cell Lung Cancer (SCLC)	1.390	NA	Not reported	Not reported	Only one participant analyzed

SUV max:Nodal (2.50 hours)

Analysis denominator · Participants

Group	Source count
Breast	2
Prostate	2
Colorectal	2
Non-Small Cell Lung Cancer (NSCLC)	3
Small-Cell Lung Cancer (SCLC)	1

Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Breast	10.440	13.8169	Not reported	Not reported	Not reported
Prostate	1.305	0.3323	Not reported	Not reported	Not reported
Colorectal	2.870	1.3859	Not reported	Not reported	Not reported
Non-Small Cell Lung Cancer (NSCLC)	1.783	0.6676	Not reported	Not reported	Not reported
Small-Cell Lung Cancer (SCLC)	1.180	NA	Not reported	Not reported	Only one participant analyzed

SUV max:Skeletal (2.50 hours)

Analysis denominator · Participants

Group	Source count
Breast	2
Prostate	2
Colorectal	0
Non-Small Cell Lung Cancer (NSCLC)	0
Small-Cell Lung Cancer (SCLC)	0

Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Breast	15.475	20.9091	Not reported	Not reported	Not reported
Prostate	2.115	1.0677	Not reported	Not reported	Not reported

SUV max:Skin/Superficial (2.50 hours)

Analysis denominator · Participants

Group	Source count
Breast	1
Prostate	0
Colorectal	1
Non-Small Cell Lung Cancer (NSCLC)	0
Small-Cell Lung Cancer (SCLC)	0

Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Breast	7.950	NA	Not reported	Not reported	Only one participant analyzed
Colorectal	0.600	NA	Not reported	Not reported	Only one participant analyzed

SUV max:Soft Tissue/Visceral (2.50 hours)

Analysis denominator · Participants

Group	Source count
Breast	3
Prostate	4
Colorectal	5
Non-Small Cell Lung Cancer (NSCLC)	3
Small-Cell Lung Cancer (SCLC)	1

Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Breast	22.140	19.3278	Not reported	Not reported	Not reported
Prostate	17.463	19.9790	Not reported	Not reported	Not reported
Colorectal	2.890	0.5866	Not reported	Not reported	Not reported
Non-Small Cell Lung Cancer (NSCLC)	2.000	0.8982	Not reported	Not reported	Not reported
Small-Cell Lung Cancer (SCLC)	1.390	NA	Not reported	Not reported	Only one participant analyzed

Complete source fields

classes

categories
measurements
group Id
OG001
spread
1.1164
value
2.166
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
5
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants
title
SUV max:Overall (0.05 hours)
categories
measurements
comment
Only one participant analyzed
group Id
OG001
spread
NA
value
0.880
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants
title
SUV max:Nodal (0.05 hours)
categories
measurements
comment
Only one participant analyzed
group Id
OG001
spread
NA
value
2.480
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants
title
SUV max:Skeletal (0.05 hours)
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants
title
SUV max:Skin/Superficial (0.05 hours)
categories
measurements
group Id
OG001
spread
1.2731
value
2.088
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
4
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants
title
SUV max:Soft Tissue/Visceral (0.05 hours)
categories
measurements
group Id
OG000
spread
17.5106
value
19.040
group Id
OG001
spread
24.2165
value
17.326
group Id
OG002
spread
0.7504
value
3.570
group Id
OG003
spread
0.6863
value
2.097
comment
Only one participant analyzed
group Id
OG004
spread
NA
value
1.810
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
5
group Id
OG002
value
5
group Id
OG003
value
3
group Id
OG004
value
1
units
Participants
title
SUV max:Overall (1.50 hours)
categories
measurements
group Id
OG000
spread
11.3986
value
9.070
group Id
OG001
spread
0.4313
value
1.505
group Id
OG002
spread
0.5233
value
2.090
group Id
OG003
spread
0.7139
value
1.917
comment
Only one participant analyzed
group Id
OG004
spread
NA
value
1.450
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
3
group Id
OG004
value
1
units
Participants
title
SUV max:Nodal (1.50 hours)
categories
measurements
group Id
OG000
spread
13.0461
value
10.325
group Id
OG001
spread
0.9687
value
2.135
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants
title
SUV max:Skeletal (1.50 hours)
categories
measurements
comment
Only one participant analyzed
group Id
OG000
spread
NA
value
7.400
comment
Only one participant analyzed
group Id
OG002
spread
NA
value
0.750
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants
title
SUV max:Skin/Superficial (1.50 hours)
categories
measurements
group Id
OG000
spread
17.5086
value
18.580
group Id
OG001
spread
26.3485
value
20.953
group Id
OG002
spread
0.7504
value
3.570
group Id
OG003
spread
0.6863
value
2.097
comment
Only one participant analyzed
group Id
OG004
spread
NA
value
1.810
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
4
group Id
OG002
value
5
group Id
OG003
value
3
group Id
OG004
value
1
units
Participants
title
SUV max:Soft Tissue/Visceral (1.50 hours)
categories
measurements
group Id
OG000
spread
19.7908
value
23.120
group Id
OG001
spread
18.4921
value
14.544
group Id
OG002
spread
0.5866
value
2.890
group Id
OG003
spread
0.8314
value
2.050
comment
Only one participant analyzed
group Id
OG004
spread
NA
value
1.390
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
5
group Id
OG002
value
5
group Id
OG003
value
3
group Id
OG004
value
1
units
Participants
title
SUV max:Overall (2.50 hours)
categories
measurements
group Id
OG000
spread
13.8169
value
10.440
group Id
OG001
spread
0.3323
value
1.305
group Id
OG002
spread
1.3859
value
2.870
group Id
OG003
spread
0.6676
value
1.783
comment
Only one participant analyzed
group Id
OG004
spread
NA
value
1.180
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
3
group Id
OG004
value
1
units
Participants
title
SUV max:Nodal (2.50 hours)

denoms

counts
group Id
OG000
value
5
group Id
OG001
value
5
group Id
OG002
value
5
group Id
OG003
value
3
group Id
OG004
value
1
units
Participants

description

Targeting properties of \[68Ga\]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.

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
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
OG001
title
Prostate
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
OG002
title
Colorectal
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
OG003
title
Non-Small Cell Lung Cancer (NSCLC)
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
OG004
title
Small-Cell Lung Cancer (SCLC)

param Type

MEAN

population Description

Full Analysis Set (FAS). The results of the biopsied samples for all patients were positive for GRPR and thus the presentation of results according to GRPR expression were no longer suitable.

reporting Status

POSTED

time Frame

[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)

title

Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location

type

PRIMARY

unit Of Measure

Standard Uptake Value (SUV)

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Preserved source evidence · Not medical advice