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NCT02658968 · OUTCOME

Dosimetry

Study of Betalutin for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma (LYMRIT-37-05) · Source last updated 2024-01-16

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

Measure
NUMBER
Unit
Gray
Interval / dispersion
Not reported
Time frame
3 weeks

What was measured

Dosimetry will be evaluated by the estimated absorbed radiation dose to target organs.

Analysis population: Participants having dosimetry evaluation and having the schedule of whole body imaging or SPECT/CT scans

Groups in this outcome

60/10

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 pre-dosing.

100/10

Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.

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

Analysis denominator · Participants

GroupSource count
60/101
100/101

Reported measurements

Liver
Values in Gray · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
60/101.33Not reportedNot reportedNot reportedNot reported
100/100.46Not reportedNot reportedNot reportedNot reported
Spleen
Values in Gray · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
60/101.39Not reportedNot reportedNot reportedNot reported
100/102.63Not reportedNot reportedNot reportedNot reported
Kidneys
Values in Gray · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
60/100.70Not reportedNot reportedNot reportedNot reported
100/100.73Not reportedNot reportedNot reportedNot reported
Image-based Red Marrow
Values in Gray · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
60/100.52Not reportedNot reportedNot reportedNot reported
100/100.38Not reportedNot reportedNot reportedNot reported
Total Body
Values in Gray · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
60/100.07Not reportedNot reportedNot reportedNot reported
100/101.16Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.33
      2. group Id
        OG001
        value
        0.46
    title
    Liver
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1.39
      2. group Id
        OG001
        value
        2.63
    title
    Spleen
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0.70
      2. group Id
        OG001
        value
        0.73
    title
    Kidneys
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0.52
      2. group Id
        OG001
        value
        0.38
    title
    Image-based Red Marrow
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0.07
      2. group Id
        OG001
        value
        1.16
    title
    Total Body
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    units
    Participants
description
Dosimetry will be evaluated by the estimated absorbed radiation dose to target organs.
groups
  1. description
    Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 pre-dosing.
    id
    OG000
    title
    60/10
  2. description
    Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.
    id
    OG001
    title
    100/10
param Type
NUMBER
population Description
Participants having dosimetry evaluation and having the schedule of whole body imaging or SPECT/CT scans
reporting Status
POSTED
time Frame
3 weeks
title
Dosimetry
type
SECONDARY
unit Of Measure
Gray

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

Preserved source evidence · Not medical advice