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NCT03665155 · OUTCOME

Average Absorbed Radiation Dose Estimates for Normal Tissues for Phase I Participants

First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody · Source last updated 2021-07-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
mSv/MBq
Interval / dispersion
Standard Error
Time frame
up to 19 months

What was measured

Standardized uptake value (SUV) in various organs will be estimated from VOI analysis of clinical images and converted to activity-time curves. The areas under the activity-time curves will be derived by integration, converted to residence times, and used as input to the OLINDA/EXM dosimetry program to obtain absorbed dose estimates for normal tissues for all Phase I participants, regardless of study dose. Each participant underwent four PET/CT scans over the next 8 days, as well as blood chemistry and whole-body counts, to determine safety, tracer biodistribution, pharmacokinetics, and radiation dosimetry. Because 89Zr has a half-life of 78 hours, only a single administration of tracer was needed to obtain all four PET/CT scans for all Phase I participants. Results were combined because all received the same dose of tracer.

Groups in this outcome

89Zr-daratumumab

The Phase I portion of the study has concluded. The Phase II portion has not yet opened to accrual.

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

Analysis denominator · Participants

GroupSource count
89Zr-daratumumab11

Reported measurements

Source class 1
Values in mSv/MBq · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
89Zr-daratumumab0.490.07Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.07
        value
        0.49
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
Standardized uptake value (SUV) in various organs will be estimated from VOI analysis of clinical images and converted to activity-time curves. The areas under the activity-time curves will be derived by integration, converted to residence times, and used as input to the OLINDA/EXM dosimetry program to obtain absorbed dose estimates for normal tissues for all Phase I participants, regardless of study dose. Each participant underwent four PET/CT scans over the next 8 days, as well as blood chemistry and whole-body counts, to determine safety, tracer biodistribution, pharmacokinetics, and radiation dosimetry. Because 89Zr has a half-life of 78 hours, only a single administration of tracer was needed to obtain all four PET/CT scans for all Phase I participants. Results were combined because all received the same dose of tracer.
dispersion Type
Standard Error
groups
  1. description
    The Phase I portion of the study has concluded. The Phase II portion has not yet opened to accrual.
    id
    OG000
    title
    89Zr-daratumumab
param Type
MEAN
reporting Status
POSTED
time Frame
up to 19 months
title
Average Absorbed Radiation Dose Estimates for Normal Tissues for Phase I Participants
type
PRIMARY
unit Of Measure
mSv/MBq

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

Preserved source evidence · Not medical advice