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NCT03724253 · OUTCOME

Non-Dosimetry Group: Standard Uptake Value (SUV) Mean 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 mean: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	1.634	0.8221	Not reported	Not reported	Not reported

SUV mean: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	0.630	NA	Not reported	Not reported	Only one participant analyzed

SUV mean: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	1.890	NA	Not reported	Not reported	Only one participant analyzed

SUV mean: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 mean: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	1.558	0.9517	Not reported	Not reported	Not reported

SUV mean: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	6.833	5.0645	Not reported	Not reported	Not reported
Prostate	11.638	15.9172	Not reported	Not reported	Not reported
Colorectal	2.582	0.8142	Not reported	Not reported	Not reported
Non-Small Cell Lung Cancer (NSCLC)	1.560	0.4468	Not reported	Not reported	Not reported
Small-Cell Lung Cancer (SCLC)	1.250	NA	Not reported	Not reported	Only one participant analyzed

SUV mean: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	4.720	5.4447	Not reported	Not reported	Not reported
Prostate	1.080	0.2263	Not reported	Not reported	Not reported
Colorectal	1.700	0.3960	Not reported	Not reported	Not reported
Non-Small Cell Lung Cancer (NSCLC)	1.560	0.4468	Not reported	Not reported	Not reported
Small-Cell Lung Cancer (SCLC)	1.250	NA	Not reported	Not reported	Only one participant analyzed

SUV mean: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	3.670	4.0164	Not reported	Not reported	Not reported
Prostate	1.470	0.7778	Not reported	Not reported	Not reported

SUV mean: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	4.370	NA	Not reported	Not reported	Only one participant analyzed
Colorectal	0.560	NA	Not reported	Not reported	Only one participant analyzed

SUV mean: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	6.833	5.0645	Not reported	Not reported	Not reported
Prostate	14.043	17.2993	Not reported	Not reported	Not reported
Colorectal	2.582	0.8142	Not reported	Not reported	Not reported
Non-Small Cell Lung Cancer (NSCLC)	1.427	0.4274	Not reported	Not reported	Not reported
Small-Cell Lung Cancer (SCLC)	1.150	NA	Not reported	Not reported	Only one participant analyzed

SUV mean: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	6.903	5.4174	Not reported	Not reported	Not reported
Prostate	9.088	10.7319	Not reported	Not reported	Not reported
Colorectal	2.258	0.9105	Not reported	Not reported	Not reported
Non-Small Cell Lung Cancer (NSCLC)	1.273	0.2386	Not reported	Not reported	Not reported
Small-Cell Lung Cancer (SCLC)	0.850	NA	Not reported	Not reported	Only one participant analyzed

SUV mean: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	4.900	6.0528	Not reported	Not reported	Not reported
Prostate	0.800	0.2687	Not reported	Not reported	Not reported
Colorectal	2.715	1.5344	Not reported	Not reported	Not reported
Non-Small Cell Lung Cancer (NSCLC)	1.273	0.2386	Not reported	Not reported	Not reported
Small-Cell Lung Cancer (SCLC)	0.850	NA	Not reported	Not reported	Only one participant analyzed

SUV mean: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	3.685	4.4336	Not reported	Not reported	Not reported
Prostate	1.455	0.8415	Not reported	Not reported	Not reported

SUV mean: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	4.360	NA	Not reported	Not reported	Only one participant analyzed
Colorectal	0.450	NA	Not reported	Not reported	Only one participant analyzed

SUV mean: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	6.903	5.4174	Not reported	Not reported	Not reported
Prostate	10.848	11.5294	Not reported	Not reported	Not reported
Colorectal	2.060	0.5115	Not reported	Not reported	Not reported
Non-Small Cell Lung Cancer (NSCLC)	1.193	0.3250	Not reported	Not reported	Not reported
Small-Cell Lung Cancer (SCLC)	0.710	NA	Not reported	Not reported	Only one participant analyzed

Complete source fields

classes

categories
measurements
group Id
OG001
spread
0.8221
value
1.634
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 mean:Overall (0.05 hours)
categories
measurements
comment
Only one participant analyzed
group Id
OG001
spread
NA
value
0.630
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 mean:Nodal (0.05 hours)
categories
measurements
comment
Only one participant analyzed
group Id
OG001
spread
NA
value
1.890
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 mean: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 mean:Skin/Superficial (0.05 hours)
categories
measurements
group Id
OG001
spread
0.9517
value
1.558
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 mean:Soft Tissue/Visceral (0.05 hours)
categories
measurements
group Id
OG000
spread
5.0645
value
6.833
group Id
OG001
spread
15.9172
value
11.638
group Id
OG002
spread
0.8142
value
2.582
group Id
OG003
spread
0.4468
value
1.560
comment
Only one participant analyzed
group Id
OG004
spread
NA
value
1.250
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 mean:Overall (1.50 hours)
categories
measurements
group Id
OG000
spread
5.4447
value
4.720
group Id
OG001
spread
0.2263
value
1.080
group Id
OG002
spread
0.3960
value
1.700
group Id
OG003
spread
0.4468
value
1.560
comment
Only one participant analyzed
group Id
OG004
spread
NA
value
1.250
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 mean:Nodal (1.50 hours)
categories
measurements
group Id
OG000
spread
4.0164
value
3.670
group Id
OG001
spread
0.7778
value
1.470
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 mean:Skeletal (1.50 hours)
categories
measurements
comment
Only one participant analyzed
group Id
OG000
spread
NA
value
4.370
comment
Only one participant analyzed
group Id
OG002
spread
NA
value
0.560
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 mean:Skin/Superficial (1.50 hours)
categories
measurements
group Id
OG000
spread
5.0645
value
6.833
group Id
OG001
spread
17.2993
value
14.043
group Id
OG002
spread
0.8142
value
2.582
group Id
OG003
spread
0.4274
value
1.427
comment
Only one participant analyzed
group Id
OG004
spread
NA
value
1.150
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 mean:Soft Tissue/Visceral (1.50 hours)
categories
measurements
group Id
OG000
spread
5.4174
value
6.903
group Id
OG001
spread
10.7319
value
9.088
group Id
OG002
spread
0.9105
value
2.258
group Id
OG003
spread
0.2386
value
1.273
comment
Only one participant analyzed
group Id
OG004
spread
NA
value
0.850
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 mean:Overall (2.50 hours)
categories
measurements
group Id
OG000
spread
6.0528
value
4.900
group Id
OG001
spread
0.2687
value
0.800
group Id
OG002
spread
1.5344
value
2.715
group Id
OG003
spread
0.2386
value
1.273
comment
Only one participant analyzed
group Id
OG004
spread
NA
value
0.850
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 mean: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) Mean by Timepoint and Lesion Location

type

PRIMARY

unit Of Measure

Standard Uptake Value (SUV)

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Preserved source evidence · Not medical advice