Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03724253 · OUTCOME

Dosimetry Group: Absorbed Dose in Target Organs

[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
mGy/MBq
Interval / dispersion
Not reported
Time frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1

What was measured

The absorbed dose in target organs and the effective radiation dose were to be summarized with descriptive statistics. Lesion number were assigned by dosimetry expert.

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. Due to the sample size in the dosimetry group (2 patients), summary statistics were not performed.

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

Participant 1-Alveolar interstital (Lungs)

Analysis denominator · Participants

GroupSource count
Breast1
Values in mGy/MBq · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast0.0359Not reportedNot reportedNot reportedNot reported
Participant 1-Bone Marrow

Analysis denominator · Participants

GroupSource count
Breast1
Values in mGy/MBq · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast0.0118Not reportedNot reportedNot reportedNot reported
Participant 1-Heart

Analysis denominator · Participants

GroupSource count
Breast1
Values in mGy/MBq · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast0.0361Not reportedNot reportedNot reportedNot reported
Participant 1-Kidneys

Analysis denominator · Participants

GroupSource count
Breast1
Values in mGy/MBq · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast0.0467Not reportedNot reportedNot reportedNot reported
Participant 1-Liver

Analysis denominator · Participants

GroupSource count
Breast1
Values in mGy/MBq · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast0.0670Not reportedNot reportedNot reportedNot reported
Participant 1-Pancreas

Analysis denominator · Participants

GroupSource count
Breast1
Values in mGy/MBq · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast0.3620Not reportedNot reportedNot reportedNot reported
Participant 1-Spleen

Analysis denominator · Participants

GroupSource count
Breast1
Values in mGy/MBq · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast0.0221Not reportedNot reportedNot reportedNot reported
Participant 1-Urinary bladder wall

Analysis denominator · Participants

GroupSource count
Breast1
Values in mGy/MBq · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast0.0683Not reportedNot reportedNot reportedNot reported
Participant 2-Alveolar interstital (Lungs)

Analysis denominator · Participants

GroupSource count
Breast1
Values in mGy/MBq · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast0.0241Not reportedNot reportedNot reportedNot reported
Participant 2-Bone Marrow

Analysis denominator · Participants

GroupSource count
Breast1
Values in mGy/MBq · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast0.0064Not reportedNot reportedNot reportedNot reported
Participant 2-Heart

Analysis denominator · Participants

GroupSource count
Breast1
Values in mGy/MBq · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast0.0158Not reportedNot reportedNot reportedNot reported
Participant 2-Kidneys

Analysis denominator · Participants

GroupSource count
Breast1
Values in mGy/MBq · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast0.0339Not reportedNot reportedNot reportedNot reported
Participant 2-Liver

Analysis denominator · Participants

GroupSource count
Breast1
Values in mGy/MBq · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast0.0450Not reportedNot reportedNot reportedNot reported
Participant 2-Pancreas

Analysis denominator · Participants

GroupSource count
Breast1
Values in mGy/MBq · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast0.2270Not reportedNot reportedNot reportedNot reported
Participant 2-Spleen

Analysis denominator · Participants

GroupSource count
Breast1
Values in mGy/MBq · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast0.0189Not reportedNot reportedNot reportedNot reported
Participant 2-Urinary bladder wall

Analysis denominator · Participants

GroupSource count
Breast1
Values in mGy/MBq · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Breast0.1010Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0359
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Participant 1-Alveolar interstital (Lungs)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0118
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Participant 1-Bone Marrow
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0361
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Participant 1-Heart
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0467
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Participant 1-Kidneys
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0670
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Participant 1-Liver
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0.3620
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Participant 1-Pancreas
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0221
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Participant 1-Spleen
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0683
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Participant 1-Urinary bladder wall
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0241
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Participant 2-Alveolar interstital (Lungs)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0064
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Participant 2-Bone Marrow
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0158
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Participant 2-Heart
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0339
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Participant 2-Kidneys
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
The absorbed dose in target organs and the effective radiation dose were to be summarized with descriptive statistics. Lesion number were assigned by dosimetry expert.
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
NUMBER
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. Due to the sample size in the dosimetry group (2 patients), summary statistics were not performed.
reporting Status
POSTED
time Frame
[68Ga]-NeoBOMB1 PET imaging acquired at Day 1
title
Dosimetry Group: Absorbed Dose in Target Organs
type
SECONDARY
unit Of Measure
mGy/MBq

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

Preserved source evidence · Not medical advice