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NCT03724253 · OUTCOME

Dosimetry Group: Standard Uptake Value (SUV) Mean 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 mean:Overall (0.15 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast5.6155.1265Not reportedNot reportedNot reported
SUV mean:Nodal (0.15 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast2.5651.0394Not reportedNot reportedNot reported
SUV mean:Skeletal (0.15 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast2.1400.2121Not reportedNot reportedNot reported
SUV mean:Skin/Superficial (0.15 hours)

Analysis denominator · Participants

GroupSource count
Breast1
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast1.250NANot reportedNot reportedOnly one participant analyzed
SUV mean:Soft Tissue/Visceral (0.15 hours)

Analysis denominator · Participants

GroupSource count
Breast1
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast9.240NANot reportedNot reportedOnly one participant analyzed
SUV mean:Overall (1.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast4.8405.1336Not reportedNot reportedNot reported
SUV mean:Nodal (1.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast2.0351.1667Not reportedNot reportedNot reported
SUV mean:Skeletal (1.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast1.9351.2233Not reportedNot reportedNot reported
SUV mean:Skin/Superficial (1.00 hours)

Analysis denominator · Participants

GroupSource count
Breast1
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast1.520NANot reportedNot reportedOnly one participant analyzed
SUV mean:Soft Tissue/Visceral (1.00 hours)

Analysis denominator · Participants

GroupSource count
Breast1
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast8.470NANot reportedNot reportedOnly one participant analyzed
SUV mean:Overall ( 2.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast4.9355.4659Not reportedNot reportedNot reported
SUV mean:Nodal ( 2.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast1.8651.1667Not reportedNot reportedNot reported
SUV mean:Skeletal ( 2.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast1.6350.7990Not reportedNot reportedNot reported
SUV mean:Skin/Superficial ( 2.00 hours)

Analysis denominator · Participants

GroupSource count
Breast1
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast1.650NANot reportedNot reportedOnly one participant analyzed
SUV mean:Soft Tissue/Visceral ( 2.00 hours)

Analysis denominator · Participants

GroupSource count
Breast1
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast8.800NANot reportedNot reportedOnly one participant analyzed
SUV mean:Overall ( 4.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast5.1055.7064Not reportedNot reportedNot reported
SUV mean:Nodal ( 4.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast1.4751.0819Not reportedNot reportedNot reported
SUV mean:Skeletal ( 4.00 hours)

Analysis denominator · Participants

GroupSource count
Breast2
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast1.9301.2162Not reportedNot reportedNot reported
SUV mean:Skin/Superficial ( 4.00 hours)

Analysis denominator · Participants

GroupSource count
Breast1
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast1.100NANot reportedNot reportedOnly one participant analyzed
SUV mean:Soft Tissue/Visceral ( 4.00 hours)

Analysis denominator · Participants

GroupSource count
Breast1
Values in Standard Uptake Value (SUV) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Breast9.140NANot reportedNot reportedOnly one participant analyzed
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.1265
        value
        5.615
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    SUV mean:Overall (0.15 hours)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.0394
        value
        2.565
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    SUV mean:Nodal (0.15 hours)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.2121
        value
        2.140
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    SUV mean:Skeletal (0.15 hours)
  4. categories
    1. measurements
      1. comment
        Only one participant analyzed
        group Id
        OG000
        spread
        NA
        value
        1.250
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    SUV mean:Skin/Superficial (0.15 hours)
  5. categories
    1. measurements
      1. comment
        Only one participant analyzed
        group Id
        OG000
        spread
        NA
        value
        9.240
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    SUV mean:Soft Tissue/Visceral (0.15 hours)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.1336
        value
        4.840
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    SUV mean:Overall (1.00 hours)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.1667
        value
        2.035
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    SUV mean:Nodal (1.00 hours)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.2233
        value
        1.935
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    SUV mean:Skeletal (1.00 hours)
  9. categories
    1. measurements
      1. comment
        Only one participant analyzed
        group Id
        OG000
        spread
        NA
        value
        1.520
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    SUV mean:Skin/Superficial (1.00 hours)
  10. categories
    1. measurements
      1. comment
        Only one participant analyzed
        group Id
        OG000
        spread
        NA
        value
        8.470
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    SUV mean:Soft Tissue/Visceral (1.00 hours)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.4659
        value
        4.935
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    SUV mean:Overall ( 2.00 hours)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.1667
        value
        1.865
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    SUV mean: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) Mean by Timepoint and Lesion Location
type
PRIMARY
unit Of Measure
Standard Uptake Value (SUV)

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Preserved source evidence · Not medical advice