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NCT03724253 · OUTCOME

Lesion-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 lesion level, overall, positive, and negative agreement of \[68Ga\]-NeoBOMB1 were to be calculated based on the aforementioned tabulations as follows: * Overall agreement = 100% x (Double positive + Double negative) / total number of lesions identified by either imaging proceduresg * Positive agreement = 100% x Double positive / (Double positive + Comparator single positive) * Negative agreement = 100% x Double negative / (Double negative + Comparator single negative).

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
Breast52.2Not reported41.562.7Not reported
Prostate14.5Not reported7.225.0Not reported
Colorectal29.5Not reported18.542.6Not reported
Non-Small Cell Lung Cancer (NSCLC)33.3Not reported17.352.8Not reported
Small-Cell Lung Cancer (SCLC)50.0Not reported1.398.7Not 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
Breast37.2Not reported28.946.2Not reported
Prostate14.3Not reported7.124.7Not reported
Colorectal29.5Not reported18.542.6Not reported
Non-Small Cell Lung Cancer (NSCLC)33.3Not reported17.352.8Not reported
Small-Cell Lung Cancer (SCLC)50.0Not reported1.398.7Not 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
Breast64.3Not reported35.187.2Not reported
Prostate0.0Not reported0.030.8Not reported
Colorectal66.7Not reported9.499.2Not reported
Non-Small Cell Lung Cancer (NSCLC)26.9Not reported11.647.8Not 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
Breast64.3Not reported35.187.2Not reported
Prostate0.0Not reported0.028.5Not reported
Colorectal66.7Not reported9.499.2Not reported
Non-Small Cell Lung Cancer (NSCLC)26.9Not reported11.647.8Not 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
Breast22.9Not reported12.037.3Not reported
Prostate11.1Not reported4.222.6Not 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
Breast18.3Not reported9.530.4Not reported
Prostate11.1Not reported4.222.6Not 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
Breast92.9Not reported76.599.1Not reported
Prostate80.0Not reported28.499.5Not reported
Colorectal28.1Not reported17.041.5Not reported
Non-Small Cell Lung Cancer (NSCLC)75.0Not reported19.499.4Not 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
Breast49.1Not reported35.163.2Not reported
Prostate80.0Not reported28.499.5Not reported
Colorectal28.1Not reported17.041.5Not reported
Non-Small Cell Lung Cancer (NSCLC)75.0Not reported19.499.4Not 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
        41.5
        upper Limit
        62.7
        value
        52.2
      2. group Id
        OG001
        lower Limit
        7.2
        upper Limit
        25.0
        value
        14.5
      3. group Id
        OG002
        lower Limit
        18.5
        upper Limit
        42.6
        value
        29.5
      4. group Id
        OG003
        lower Limit
        17.3
        upper Limit
        52.8
        value
        33.3
      5. group Id
        OG004
        lower Limit
        1.3
        upper Limit
        98.7
        value
        50.0
    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
        28.9
        upper Limit
        46.2
        value
        37.2
      2. group Id
        OG001
        lower Limit
        7.1
        upper Limit
        24.7
        value
        14.3
      3. group Id
        OG002
        lower Limit
        18.5
        upper Limit
        42.6
        value
        29.5
      4. group Id
        OG003
        lower Limit
        17.3
        upper Limit
        52.8
        value
        33.3
      5. group Id
        OG004
        lower Limit
        1.3
        upper Limit
        98.7
        value
        50.0
    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
        35.1
        upper Limit
        87.2
        value
        64.3
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        30.8
        value
        0.0
      3. group Id
        OG002
        lower Limit
        9.4
        upper Limit
        99.2
        value
        66.7
      4. group Id
        OG003
        lower Limit
        11.6
        upper Limit
        47.8
        value
        26.9
      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
        35.1
        upper Limit
        87.2
        value
        64.3
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        28.5
        value
        0.0
      3. group Id
        OG002
        lower Limit
        9.4
        upper Limit
        99.2
        value
        66.7
      4. group Id
        OG003
        lower Limit
        11.6
        upper Limit
        47.8
        value
        26.9
      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
        12.0
        upper Limit
        37.3
        value
        22.9
      2. group Id
        OG001
        lower Limit
        4.2
        upper Limit
        22.6
        value
        11.1
    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
        9.5
        upper Limit
        30.4
        value
        18.3
      2. group Id
        OG001
        lower Limit
        4.2
        upper Limit
        22.6
        value
        11.1
    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
        76.5
        upper Limit
        99.1
        value
        92.9
      2. group Id
        OG001
        lower Limit
        28.4
        upper Limit
        99.5
        value
        80.0
      3. group Id
        OG002
        lower Limit
        17.0
        upper Limit
        41.5
        value
        28.1
      4. group Id
        OG003
        lower Limit
        19.4
        upper Limit
        99.4
        value
        75.0
      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
        35.1
        upper Limit
        63.2
        value
        49.1
      2. group Id
        OG001
        lower Limit
        28.4
        upper Limit
        99.5
        value
        80.0
      3. group Id
        OG002
        lower Limit
        17.0
        upper Limit
        41.5
        value
        28.1
      4. group Id
        OG003
        lower Limit
        19.4
        upper Limit
        99.4
        value
        75.0
      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 lesion level, overall, positive, and negative agreement of \[68Ga\]-NeoBOMB1 were to be calculated based on the aforementioned tabulations as follows: * Overall agreement = 100% x (Double positive + Double negative) / total number of lesions identified by either imaging proceduresg * Positive agreement = 100% x Double positive / (Double positive + Comparator single positive) * Negative agreement = 100% x Double negative / (Double negative + Comparator single negative).
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
Lesion-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