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NCT04711135 · OUTCOME

Absorbed Radiation Doses in Target Organ

Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs · Source last updated 2026-02-12

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

Measure
MEAN
Unit
Gy/GBq
Interval / dispersion
Standard Deviation
Time frame
Up to 8 days after the first Lutetium [Lu 177] dotatate dose

What was measured

Absorbed radiation doses in target organ (e.g. kidney and bone marrow) was evaluated when all Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) and Pheochromocytoma and paraganglioma (PPGLs) as a pooled cohort patients had completed the 1st treatment of Lutathera and completed the dosimetry assessment.

Analysis population: Dosimetry Analysis Set (DAS): The DAS consisted of all participants who had at least one valid (i.e., not flagged for exclusion by the dosimetrist) dosimetry measurement.

Groups in this outcome

GEP-NET

All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.

PPGL

All eligible participants with Pheochromocytoma and paraganglioma (PPGL) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.

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

Analysis denominator · Participants

GroupSource count
GEP-NET4
PPGL6

Reported measurements

Kidney

Analysis denominator · Participants

GroupSource count
GEP-NET4
PPGL6
Values in Gy/GBq · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
GEP-NET0.710.25Not reportedNot reportedNot reported
PPGL0.820.32Not reportedNot reportedNot reported
Pituitary

Analysis denominator · Participants

GroupSource count
GEP-NET3
PPGL6
Values in Gy/GBq · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
GEP-NET1.20.43Not reportedNot reportedNot reported
PPGL1.00.45Not reportedNot reportedNot reported
Red Marrow (Blood)

Analysis denominator · Participants

GroupSource count
GEP-NET4
PPGL6
Values in Gy/GBq · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
GEP-NET0.0240.0035Not reportedNot reportedNot reported
PPGL0.0280.0052Not reportedNot reportedNot reported
Red Marrow (Image)

Analysis denominator · Participants

GroupSource count
GEP-NET4
PPGL6
Values in Gy/GBq · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
GEP-NET0.0430.018Not reportedNot reportedNot reported
PPGL0.0670.028Not reportedNot reportedNot reported
Spleen

Analysis denominator · Participants

GroupSource count
GEP-NET4
PPGL6
Values in Gy/GBq · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
GEP-NET0.630.39Not reportedNot reportedNot reported
PPGL0.820.17Not reportedNot reportedNot reported
Urinary Bladder Wall

Analysis denominator · Participants

GroupSource count
GEP-NET4
PPGL6
Values in Gy/GBq · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
GEP-NET0.500.034Not reportedNot reportedNot reported
PPGL0.590.096Not reportedNot reportedNot reported
Total Body

Analysis denominator · Participants

GroupSource count
GEP-NET4
PPGL6
Values in Gy/GBq · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
GEP-NET0.0400.013Not reportedNot reportedNot reported
PPGL0.0410.0073Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.25
        value
        0.71
      2. group Id
        OG001
        spread
        0.32
        value
        0.82
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Kidney
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.43
        value
        1.2
      2. group Id
        OG001
        spread
        0.45
        value
        1.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Pituitary
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0035
        value
        0.024
      2. group Id
        OG001
        spread
        0.0052
        value
        0.028
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Red Marrow (Blood)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.018
        value
        0.043
      2. group Id
        OG001
        spread
        0.028
        value
        0.067
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Red Marrow (Image)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.39
        value
        0.63
      2. group Id
        OG001
        spread
        0.17
        value
        0.82
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Spleen
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.034
        value
        0.50
      2. group Id
        OG001
        spread
        0.096
        value
        0.59
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Urinary Bladder Wall
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.013
        value
        0.040
      2. group Id
        OG001
        spread
        0.0073
        value
        0.041
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Total Body
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      6
    units
    Participants
description
Absorbed radiation doses in target organ (e.g. kidney and bone marrow) was evaluated when all Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) and Pheochromocytoma and paraganglioma (PPGLs) as a pooled cohort patients had completed the 1st treatment of Lutathera and completed the dosimetry assessment.
dispersion Type
Standard Deviation
groups
  1. description
    All eligible participants with Gastroenteropancreatic neuroendocrine tumor (GEP-NET) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
    id
    OG000
    title
    GEP-NET
  2. description
    All eligible participants with Pheochromocytoma and paraganglioma (PPGL) received at least one dose of Lutathera (7.4 GBq/200 mCi x 4 administrations every 8+/-1 weeks; cumulative dose: 29.6 GBq/800 mCi), with a concomitant administration of 2.5% Lysine - Arginine amino acid solution.
    id
    OG001
    title
    PPGL
param Type
MEAN
population Description
Dosimetry Analysis Set (DAS): The DAS consisted of all participants who had at least one valid (i.e., not flagged for exclusion by the dosimetrist) dosimetry measurement.
reporting Status
POSTED
time Frame
Up to 8 days after the first Lutetium [Lu 177] dotatate dose
title
Absorbed Radiation Doses in Target Organ
type
PRIMARY
unit Of Measure
Gy/GBq

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Preserved source evidence · Not medical advice