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NCT03724253 · OUTCOME

Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location

[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
MEAN
Unit
Standard Uptake Value (SUV)
Interval / dispersion
Standard Deviation
Time frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)

What was measured

Targeting properties of \[68Ga\]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated 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). Dosimetry group targeted participants with Breast Cancer and Prostate Cancer, but only 2 participants from Breast Cancer arm enrolled in the Dosimetry Group. 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%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Breast2

Reported measurements

SUV max:Overall( 0.15 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast7.5756.7104Not reportedNot reportedNot reported
SUV max:Nodal (0.15 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast3.4050.8132Not reportedNot reportedNot reported
SUV max:Skeletal (0.15 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast2.7400.3111Not reportedNot reportedNot reported
SUV max:Skin/Superficial (0.15 hours)

Analysis denominator · Participants

GroupSource count
Breast1
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast1.450NANot reportedNot reportedOnly one participant analyzed
SUV max:Soft Tissue/Visceral (0.15 hours)

Analysis denominator · Participants

GroupSource count
Breast1
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast12.320NANot reportedNot reportedOnly one participant analyzed
SUV max:Overall (1.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast11.55013.7603Not reportedNot reportedNot reported
SUV max:Nodal (1.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast2.6601.1879Not reportedNot reportedNot reported
SUV max:Skeletal (1.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast2.5951.5203Not reportedNot reportedNot reported
SUV max:Skin/Superficial (1.00 hours)

Analysis denominator · Participants

GroupSource count
Breast1
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast1.750NANot reportedNot reportedOnly one participant analyzed
SUV max:Soft Tissue/Visceral (1.00 hours)

Analysis denominator · Participants

GroupSource count
Breast1
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast21.280NANot reportedNot reportedOnly one participant analyzed
SUV max:Overall ( 2.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast13.68017.1827Not reportedNot reportedNot reported
SUV max:Nodal ( 2.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast2.6251.5486Not reportedNot reportedNot reported
SUV max:Skeletal ( 2.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast2.4451.3081Not reportedNot reportedNot reported
SUV max:Skin/Superficial ( 2.00 hours)

Analysis denominator · Participants

GroupSource count
Breast1
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast2.080NANot reportedNot reportedOnly one participant analyzed
SUV max:Soft Tissue/Visceral ( 2.00 hours)

Analysis denominator · Participants

GroupSource count
Breast1
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast25.830NANot reportedNot reportedOnly one participant analyzed
SUV max:Overall ( 4.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast13.95017.5787Not reportedNot reportedNot reported
SUV max:Nodal ( 4.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast2.0501.3011Not reportedNot reportedNot reported
SUV max:Skeletal ( 4.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast3.2052.3829Not reportedNot reportedNot reported
SUV max:Skin/Superficial ( 4.00 hours)

Analysis denominator · Participants

GroupSource count
Breast1
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast1.640NANot reportedNot reportedOnly one participant analyzed
SUV max:Soft Tissue/Visceral ( 4.00 hours)

Analysis denominator · Participants

GroupSource count
Breast1
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast26.380NANot reportedNot reportedOnly one participant analyzed
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.7104
        value
        7.575
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    SUV max:Overall( 0.15 hours)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.8132
        value
        3.405
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    SUV max:Nodal (0.15 hours)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.3111
        value
        2.740
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    SUV max:Skeletal (0.15 hours)
  4. categories
    1. measurements
      1. comment
        Only one participant analyzed
        group Id
        OG000
        spread
        NA
        value
        1.450
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    SUV max:Skin/Superficial (0.15 hours)
  5. categories
    1. measurements
      1. comment
        Only one participant analyzed
        group Id
        OG000
        spread
        NA
        value
        12.320
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    SUV max:Soft Tissue/Visceral (0.15 hours)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.7603
        value
        11.550
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    SUV max:Overall (1.00 hours)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.1879
        value
        2.660
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    SUV max:Nodal (1.00 hours)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.5203
        value
        2.595
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    SUV max:Skeletal (1.00 hours)
  9. categories
    1. measurements
      1. comment
        Only one participant analyzed
        group Id
        OG000
        spread
        NA
        value
        1.750
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    SUV max:Skin/Superficial (1.00 hours)
  10. categories
    1. measurements
      1. comment
        Only one participant analyzed
        group Id
        OG000
        spread
        NA
        value
        21.280
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    SUV max:Soft Tissue/Visceral (1.00 hours)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.1827
        value
        13.680
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    SUV max:Overall ( 2.00 hours)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.5486
        value
        2.625
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    SUV max:Nodal ( 2.00 hours)
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
Targeting properties of \[68Ga\]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.
dispersion Type
Standard Deviation
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
param Type
MEAN
population Description
Full Analysis Set (FAS). Dosimetry group targeted participants with Breast Cancer and Prostate Cancer, but only 2 participants from Breast Cancer arm enrolled in the Dosimetry Group. 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 (0.15, 1.00, 2.00 and 4.00 hours)
title
Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location
type
PRIMARY
unit Of Measure
Standard Uptake Value (SUV)

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Preserved source evidence · Not medical advice