TriangleNCT03724253 · OUTCOME
Number of Lesions Detected by [68Ga]-NeoBOMB1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Lesion
- Interval / dispersion
- Standard Deviation
- Time frame
- [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
What was measured
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.
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 | Source count |
|---|---|
| Breast | 5 |
| Prostate | 5 |
| Colorectal | 5 |
| Non-Small Cell Lung Cancer (NSCLC) | 3 |
| Small-Cell Lung Cancer (SCLC) | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Breast | 17.0 | 15.57 | Not reported | Not reported | Not reported |
| Prostate | 2.2 | 1.64 | Not reported | Not reported | Not reported |
| Colorectal | 6.0 | 4.58 | Not reported | Not reported | Not reported |
| Non-Small Cell Lung Cancer (NSCLC) | 3.3 | 2.31 | Not reported | Not reported | Not reported |
| Small-Cell Lung Cancer (SCLC) | 1.0 | NA | Not reported | Not reported | Only one participant analyzed |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 15.57
- value
- 17.0
- group Id
- OG001
- spread
- 1.64
- value
- 2.2
- group Id
- OG002
- spread
- 4.58
- value
- 6.0
- group Id
- OG003
- spread
- 2.31
- value
- 3.3
- comment
- Only one participant analyzed
- group Id
- OG004
- spread
- NA
- value
- 1.0
- 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
- 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.
- 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
- title
- Number of Lesions Detected by [68Ga]-NeoBOMB1
- type
- PRIMARY
- unit Of Measure
- Lesion
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice