NCT03724253 · STUDY IN CONTEXT

[68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The preliminary targeting properties of \[68Ga\]-NeoBOMB1 were to be assessed by summarizing the number of lesions identified by Positron Emission Tomography (PET) overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.

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.

→

primary · POSTED

The preliminary targeting properties of \[68Ga\]-NeoBOMB1 were to be assessed by summarizing the location of lesions identified by PET overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.

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.

→

primary · POSTED

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.

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.

→

primary · POSTED

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.

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.

→

primary · POSTED

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.

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. 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.

→

primary · POSTED

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.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-small-cell-lung-cancer
nct id: NCT03724253
trial label: [68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0000
source section id
NCT03724253-om-0000
source outcome index
0
endpoint
Number of Lesions Detected by [68Ga]-NeoBOMB1
endpoint definition
The preliminary targeting properties of \[68Ga\]-NeoBOMB1 were to be assessed by summarizing the number of lesions identified by Positron Emission Tomography (PET) overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
time origin
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0001
source section id
NCT03724253-om-0001
source outcome index
1
endpoint
Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location
endpoint definition
The preliminary targeting properties of \[68Ga\]-NeoBOMB1 were to be assessed by summarizing the location of lesions identified by PET overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
time origin
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0002
source section id
NCT03724253-om-0002
source outcome index
2
endpoint
Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location
endpoint definition
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.
time origin
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0003
source section id
NCT03724253-om-0003
source outcome index
3
endpoint
Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location
endpoint definition
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.
time origin
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0004
source section id
NCT03724253-om-0004
source outcome index
4
endpoint
Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location
endpoint definition
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.
time origin
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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. 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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0005
source section id
NCT03724253-om-0005
source outcome index
5
endpoint
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location
endpoint definition
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.
time origin
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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. 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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0000
arm key
OG000
arm label
Breast
regimen
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03724253-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0000
arm key
OG001
arm label
Prostate
regimen
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03724253-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0000
arm key
OG002
arm label
Colorectal
regimen
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03724253-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0000
arm key
OG003
arm label
Non-Small Cell Lung Cancer (NSCLC)
regimen
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03724253-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0000
arm key
OG004
arm label
Small-Cell Lung Cancer (SCLC)
regimen
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03724253-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0001
arm key
OG000
arm label
Breast
regimen
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03724253-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0001
arm key
OG001
arm label
Prostate
regimen
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03724253-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0001
arm key
OG002
arm label
Colorectal
regimen
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03724253-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0001
arm key
OG003
arm label
Non-Small Cell Lung Cancer (NSCLC)
regimen
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03724253-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0001
arm key
OG004
arm label
Small-Cell Lung Cancer (SCLC)
regimen
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03724253-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0002
arm key
OG000
arm label
Breast
regimen
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03724253-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
outcome key
om-0002
arm key
OG001
arm label
Prostate
regimen
All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03724253-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
harm key
EG000
source section id
NCT03724253-ae
event group key
EG000
event group label
Breast
serious affected
0
serious at risk
5
other affected
0
other at risk
5
frequency threshold
5
collection period
Adverse events (AEs) were collected from informed consent signature through study completion (Day 14).
event definition
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
harm key
EG001
source section id
NCT03724253-ae
event group key
EG001
event group label
Prostate
serious affected
0
serious at risk
5
other affected
1
other at risk
5
frequency threshold
5
collection period
Adverse events (AEs) were collected from informed consent signature through study completion (Day 14).
event definition
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
harm key
EG002
source section id
NCT03724253-ae
event group key
EG002
event group label
Colorectal
serious affected
0
serious at risk
5
other affected
3
other at risk
5
frequency threshold
5
collection period
Adverse events (AEs) were collected from informed consent signature through study completion (Day 14).
event definition
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
harm key
EG003
source section id
NCT03724253-ae
event group key
EG003
event group label
Non-Small Cell Lung Cancer (NSCLC)
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
5
collection period
Adverse events (AEs) were collected from informed consent signature through study completion (Day 14).
event definition
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03724253
harm key
EG004
source section id
NCT03724253-ae
event group key
EG004
event group label
Small-Cell Lung Cancer (SCLC)
serious affected
1
serious at risk
1
other affected
1
other at risk
1
frequency threshold
5
collection period
Adverse events (AEs) were collected from informed consent signature through study completion (Day 14).
event definition
Any sign or symptom that occurs after written informed consent provided. For TEAE from first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice