TriangleNCT03724253 · OUTCOME
Number of Lesions Detected by Conventional Imaging
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
- Conventional imaging collected within 3 months prior to study entry up to [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. The number of lesions identified by aforementioned PET imaging were to be compared with the number of lesions identified by the comparable conventional imaging. 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 | 18.4 | 15.81 | Not reported | Not reported | Not reported |
| Prostate | 13.8 | 21.51 | Not reported | Not reported | Not reported |
| Colorectal | 12.2 | 9.86 | Not reported | Not reported | Not reported |
| Non-Small Cell Lung Cancer (NSCLC) | 10.0 | 7.55 | Not reported | Not reported | Not reported |
| Small-Cell Lung Cancer (SCLC) | 2.0 | NA | Not reported | Not reported | Only one participant analyzed |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 15.81
- value
- 18.4
- group Id
- OG001
- spread
- 21.51
- value
- 13.8
- group Id
- OG002
- spread
- 9.86
- value
- 12.2
- group Id
- OG003
- spread
- 7.55
- value
- 10.0
- comment
- Only one participant analyzed
- group Id
- OG004
- spread
- NA
- value
- 2.0
- 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. The number of lesions identified by aforementioned PET imaging were to be compared with the number of lesions identified by the comparable conventional imaging. 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
- Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
- title
- Number of Lesions Detected by Conventional Imaging
- type
- SECONDARY
- unit Of Measure
- Lesion
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Preserved source evidence · Not medical advice