Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03724253 · OUTCOME

Organ-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared to Histological Evidence

[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
Biopsy specimen collected within 6 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

What was measured

The diagnostic performance of \[68Ga\]-NeoBOMB1 to GRPR overexpressing malignancies (lesions) was to be compared with cytology and/or histopathology findings from archival and/or recent biopsy specimens. Since the biopsy was performed on 1 lesion (collected either in primary or in metastatic tumors), a direct link may not be possible in case of multiple lesions per organ identified on \[68Ga\]-NeoBOMB1-PET. In this event, the determination of positive versus negative lesions on \[68Ga\]-NeoBOMB1-PET was done at organ level, i.e., if any lesion is positive in that organ, then the organ was to be considered positive. The sensitivity was to be calculated as follows: Sensitivity = 100% x True positive / (True positive + False negative).

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 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

Source class 1
Values in Percent agreement · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Breast80.0Not reported28.499.5Not reported
Prostate100.0Not reported47.8100.0Not reported
Colorectal20.0Not reported0.571.6Not reported
Non-Small Cell Lung Cancer (NSCLC)100.0Not reported29.2100.0Not reported
Small-Cell Lung Cancer (SCLC)0.0Not reported0.097.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28.4
        upper Limit
        99.5
        value
        80.0
      2. group Id
        OG001
        lower Limit
        47.8
        upper Limit
        100.0
        value
        100.0
      3. group Id
        OG002
        lower Limit
        0.5
        upper Limit
        71.6
        value
        20.0
      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
description
The diagnostic performance of \[68Ga\]-NeoBOMB1 to GRPR overexpressing malignancies (lesions) was to be compared with cytology and/or histopathology findings from archival and/or recent biopsy specimens. Since the biopsy was performed on 1 lesion (collected either in primary or in metastatic tumors), a direct link may not be possible in case of multiple lesions per organ identified on \[68Ga\]-NeoBOMB1-PET. In this event, the determination of positive versus negative lesions on \[68Ga\]-NeoBOMB1-PET was done at organ level, i.e., if any lesion is positive in that organ, then the organ was to be considered positive. The sensitivity was to be calculated as follows: Sensitivity = 100% x True positive / (True positive + False 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). 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
Biopsy specimen collected within 6 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1
title
Organ-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared to Histological Evidence
type
SECONDARY
unit Of Measure
Percent agreement

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice