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NCT03724253 · OUTCOME

Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging

[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
NUMBER
Unit
Percent agreement
Interval / dispersion
95% Confidence Interval
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

At patient level, positive agreement was defined as the proportion of subjects with at least one lesion detected by conventional imaging in the specified location that also have at least one lesion detected by \[68Ga\]-NeoBOMB1. Overall agreement was defined as the proportion of subjects with at least one lesion detected in either imaging in the specified location that also have at least one lesion detected by \[68Ga\]-NeoBOMB1.

Analysis population: Full Analysis Set (FAS).

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

GroupSource count
Breast5
Prostate5
Colorectal5
Non-Small Cell Lung Cancer (NSCLC)3
Small-Cell Lung Cancer (SCLC)1

Reported measurements

Overall (Positive Agreement)

Analysis denominator · Participants

GroupSource count
Breast5
Prostate5
Colorectal5
Non-Small Cell Lung Cancer (NSCLC)3
Small-Cell Lung Cancer (SCLC)1
Values in Percent agreement · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Breast100.0Not reported47.8100.0Not reported
Prostate100.0Not reported47.8100.0Not reported
Colorectal60.0Not reported14.794.7Not reported
Non-Small Cell Lung Cancer (NSCLC)100.0Not reported29.2100.0Not reported
Small-Cell Lung Cancer (SCLC)100.0Not reported2.5100.0Not reported
Overall (Overall Agreement)

Analysis denominator · Participants

GroupSource count
Breast5
Prostate5
Colorectal5
Non-Small Cell Lung Cancer (NSCLC)3
Small-Cell Lung Cancer (SCLC)1
Values in Percent agreement · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Breast100.0Not reported47.8100.0Not reported
Prostate100.0Not reported47.8100.0Not reported
Colorectal60.0Not reported14.794.7Not reported
Non-Small Cell Lung Cancer (NSCLC)100.0Not reported29.2100.0Not reported
Small-Cell Lung Cancer (SCLC)100.0Not reported2.5100.0Not reported
Nodal (Positive Agreement)

Analysis denominator · Participants

GroupSource count
Breast5
Prostate5
Colorectal5
Non-Small Cell Lung Cancer (NSCLC)3
Small-Cell Lung Cancer (SCLC)1
Values in Percent agreement · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Breast50.0Not reported6.893.2Not reported
Prostate0.0Not reported0.097.5Not reported
Colorectal100.0Not reported15.8100.0Not reported
Non-Small Cell Lung Cancer (NSCLC)100.0Not reported29.2100.0Not reported
Small-Cell Lung Cancer (SCLC)0.0Not reported0.097.5Not reported
Nodal (Overall agreement)

Analysis denominator · Participants

GroupSource count
Breast5
Prostate5
Colorectal5
Non-Small Cell Lung Cancer (NSCLC)3
Small-Cell Lung Cancer (SCLC)1
Values in Percent agreement · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Breast50.0Not reported6.893.2Not reported
Prostate0.0Not reported0.084.2Not reported
Colorectal100.0Not reported15.8100.0Not reported
Non-Small Cell Lung Cancer (NSCLC)100.0Not reported29.2100.0Not reported
Small-Cell Lung Cancer (SCLC)0.0Not reported0.097.5Not reported
Skeletal (Positive Agreement)

Analysis denominator · Participants

GroupSource count
Breast5
Prostate5
Colorectal0
Non-Small Cell Lung Cancer (NSCLC)0
Small-Cell Lung Cancer (SCLC)0
Values in Percent agreement · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Breast100.0Not reported39.8100.0Not reported
Prostate100.0Not reported15.8100.0Not reported
Skeletal (Overall agreement)

Analysis denominator · Participants

GroupSource count
Breast5
Prostate5
Colorectal0
Non-Small Cell Lung Cancer (NSCLC)0
Small-Cell Lung Cancer (SCLC)0
Values in Percent agreement · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Breast100.0Not reported39.8100.0Not reported
Prostate100.0Not reported15.8100.0Not reported
Skin/Superficial (Positive Agreement)

Analysis denominator · Participants

GroupSource count
Breast5
Prostate0
Colorectal5
Non-Small Cell Lung Cancer (NSCLC)0
Small-Cell Lung Cancer (SCLC)0
Values in Percent agreement · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Breast100.0Not reported15.8100.0Not reported
Colorectal0.0Not reported0.097.5Not reported
Skin/Superficial (Overall agreement)

Analysis denominator · Participants

GroupSource count
Breast5
Prostate0
Colorectal5
Non-Small Cell Lung Cancer (NSCLC)0
Small-Cell Lung Cancer (SCLC)0
Values in Percent agreement · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Breast100.0Not reported15.8100.0Not reported
Colorectal0.0Not reported0.097.5Not reported
Soft Tissue/Visceral (Positive Agreement)

Analysis denominator · Participants

GroupSource count
Breast5
Prostate5
Colorectal5
Non-Small Cell Lung Cancer (NSCLC)3
Small-Cell Lung Cancer (SCLC)1
Values in Percent agreement · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Breast100.0Not reported39.8100.0Not reported
Prostate100.0Not reported39.8100.0Not reported
Colorectal40.0Not reported5.385.3Not reported
Non-Small Cell Lung Cancer (NSCLC)100.0Not reported29.2100.0Not reported
Small-Cell Lung Cancer (SCLC)100.0Not reported2.5100.0Not reported
Soft Tissue/Visceral (Overall agreement)

Analysis denominator · Participants

GroupSource count
Breast5
Prostate5
Colorectal5
Non-Small Cell Lung Cancer (NSCLC)3
Small-Cell Lung Cancer (SCLC)1
Values in Percent agreement · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Breast100.0Not reported39.8100.0Not reported
Prostate100.0Not reported39.8100.0Not reported
Colorectal40.0Not reported5.385.3Not reported
Non-Small Cell Lung Cancer (NSCLC)100.0Not reported29.2100.0Not reported
Small-Cell Lung Cancer (SCLC)100.0Not reported2.5100.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        47.8
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        47.8
        upper Limit
        100.0
        value
        100.0
      3. group Id
        OG002
        lower Limit
        14.7
        upper Limit
        94.7
        value
        60.0
      4. group Id
        OG003
        lower Limit
        29.2
        upper Limit
        100.0
        value
        100.0
      5. group Id
        OG004
        lower Limit
        2.5
        upper Limit
        100.0
        value
        100.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    Overall (Positive Agreement)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        47.8
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        47.8
        upper Limit
        100.0
        value
        100.0
      3. group Id
        OG002
        lower Limit
        14.7
        upper Limit
        94.7
        value
        60.0
      4. group Id
        OG003
        lower Limit
        29.2
        upper Limit
        100.0
        value
        100.0
      5. group Id
        OG004
        lower Limit
        2.5
        upper Limit
        100.0
        value
        100.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    Overall (Overall Agreement)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.8
        upper Limit
        93.2
        value
        50.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        97.5
        value
        0.0
      3. group Id
        OG002
        lower Limit
        15.8
        upper Limit
        100.0
        value
        100.0
      4. group Id
        OG003
        lower Limit
        29.2
        upper Limit
        100.0
        value
        100.0
      5. group Id
        OG004
        lower Limit
        0.0
        upper Limit
        97.5
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    Nodal (Positive Agreement)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.8
        upper Limit
        93.2
        value
        50.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        84.2
        value
        0.0
      3. group Id
        OG002
        lower Limit
        15.8
        upper Limit
        100.0
        value
        100.0
      4. group Id
        OG003
        lower Limit
        29.2
        upper Limit
        100.0
        value
        100.0
      5. group Id
        OG004
        lower Limit
        0.0
        upper Limit
        97.5
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    Nodal (Overall agreement)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.8
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        15.8
        upper Limit
        100.0
        value
        100.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    Skeletal (Positive Agreement)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.8
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        15.8
        upper Limit
        100.0
        value
        100.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    Skeletal (Overall agreement)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.8
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        97.5
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    Skin/Superficial (Positive Agreement)
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.8
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        97.5
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      units
      Participants
    title
    Skin/Superficial (Overall agreement)
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.8
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        39.8
        upper Limit
        100.0
        value
        100.0
      3. group Id
        OG002
        lower Limit
        5.3
        upper Limit
        85.3
        value
        40.0
      4. group Id
        OG003
        lower Limit
        29.2
        upper Limit
        100.0
        value
        100.0
      5. group Id
        OG004
        lower Limit
        2.5
        upper Limit
        100.0
        value
        100.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    Soft Tissue/Visceral (Positive Agreement)
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.8
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        39.8
        upper Limit
        100.0
        value
        100.0
      3. group Id
        OG002
        lower Limit
        5.3
        upper Limit
        85.3
        value
        40.0
      4. group Id
        OG003
        lower Limit
        29.2
        upper Limit
        100.0
        value
        100.0
      5. group Id
        OG004
        lower Limit
        2.5
        upper Limit
        100.0
        value
        100.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        1
      units
      Participants
    title
    Soft Tissue/Visceral (Overall agreement)
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      1
    units
    Participants
description
At patient level, positive agreement was defined as the proportion of subjects with at least one lesion detected by conventional imaging in the specified location that also have at least one lesion detected by \[68Ga\]-NeoBOMB1. Overall agreement was defined as the proportion of subjects with at least one lesion detected in either imaging in the specified location that also have at least one lesion detected by \[68Ga\]-NeoBOMB1.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
  3. 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
  4. 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)
  5. 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
NUMBER
population Description
Full Analysis Set (FAS).
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
Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging
type
SECONDARY
unit Of Measure
Percent agreement

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Preserved source evidence · Not medical advice