Dosimetry and pharmacokinetics of [177Lu]Lu-satoreotide tetraxetan in patients with progressive neuroendocrine tumours
© 2024. The Author(s)..
PURPOSE: To evaluate the dosimetry and pharmacokinetics of the novel radiolabelled somatostatin receptor antagonist [177Lu]Lu-satoreotide tetraxetan in patients with advanced neuroendocrine tumours (NETs).
METHODS: This study was part of a phase I/II trial of [177Lu]Lu-satoreotide tetraxetan, administered at a median cumulative activity of 13.0 GBq over three planned cycles (median activity/cycle: 4.5 GBq), in 40 patients with progressive NETs. Organ absorbed doses were monitored at each cycle using patient-specific dosimetry; the cumulative absorbed-dose limits were set at 23.0 Gy for the kidneys and 1.5 Gy for bone marrow. Absorbed dose coefficients (ADCs) were calculated using both patient-specific and model-based dosimetry for some patients.
RESULTS: In all evaluated organs, maximum [177Lu]Lu-satoreotide tetraxetan uptake was observed at the first imaging timepoint (4 h after injection), followed by an exponential decrease. Kidneys were the main route of elimination, with a cumulative excretion of 57-66% within 48 h following the first treatment cycle. At the first treatment cycle, [177Lu]Lu-satoreotide tetraxetan showed a median terminal blood half-life of 127 h and median ADCs of [177Lu]Lu-satoreotide tetraxetan were 5.0 Gy/GBq in tumours, 0.1 Gy/GBq in the bone marrow, 0.9 Gy/GBq in kidneys, 0.2 Gy/GBq in the liver and 0.8 Gy/GBq in the spleen. Using image-based dosimetry, the bone marrow and kidneys received median cumulative absorbed doses of 1.1 and 10.8 Gy, respectively, after three cycles.
CONCLUSION: [177Lu]Lu-satoreotide tetraxetan showed a favourable dosimetry profile, with high and prolonged tumour uptake, supporting its acceptable safety profile and promising efficacy.
TRIAL REGISTRATION: NCT02592707. Registered October 30, 2015.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
European journal of nuclear medicine and molecular imaging - (2024) vom: 26. März |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Schürrle, Seval Beykan [VerfasserIn] |
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| Links: |
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| Themen: |
[177Lu]Lu-satoreotide tetraxetan |
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| Anmerkungen: |
Date Revised 26.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT02592707 Citation Status Publisher |
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| doi: |
10.1007/s00259-024-06682-1 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM370177169 |
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| 100 | 1 | |a Schürrle, Seval Beykan |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Dosimetry and pharmacokinetics of [177Lu]Lu-satoreotide tetraxetan in patients with progressive neuroendocrine tumours |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
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| 500 | |a Date Revised 26.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02592707 | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a © 2024. The Author(s). | ||
| 520 | |a PURPOSE: To evaluate the dosimetry and pharmacokinetics of the novel radiolabelled somatostatin receptor antagonist [177Lu]Lu-satoreotide tetraxetan in patients with advanced neuroendocrine tumours (NETs) | ||
| 520 | |a METHODS: This study was part of a phase I/II trial of [177Lu]Lu-satoreotide tetraxetan, administered at a median cumulative activity of 13.0 GBq over three planned cycles (median activity/cycle: 4.5 GBq), in 40 patients with progressive NETs. Organ absorbed doses were monitored at each cycle using patient-specific dosimetry; the cumulative absorbed-dose limits were set at 23.0 Gy for the kidneys and 1.5 Gy for bone marrow. Absorbed dose coefficients (ADCs) were calculated using both patient-specific and model-based dosimetry for some patients | ||
| 520 | |a RESULTS: In all evaluated organs, maximum [177Lu]Lu-satoreotide tetraxetan uptake was observed at the first imaging timepoint (4 h after injection), followed by an exponential decrease. Kidneys were the main route of elimination, with a cumulative excretion of 57-66% within 48 h following the first treatment cycle. At the first treatment cycle, [177Lu]Lu-satoreotide tetraxetan showed a median terminal blood half-life of 127 h and median ADCs of [177Lu]Lu-satoreotide tetraxetan were 5.0 Gy/GBq in tumours, 0.1 Gy/GBq in the bone marrow, 0.9 Gy/GBq in kidneys, 0.2 Gy/GBq in the liver and 0.8 Gy/GBq in the spleen. Using image-based dosimetry, the bone marrow and kidneys received median cumulative absorbed doses of 1.1 and 10.8 Gy, respectively, after three cycles | ||
| 520 | |a CONCLUSION: [177Lu]Lu-satoreotide tetraxetan showed a favourable dosimetry profile, with high and prolonged tumour uptake, supporting its acceptable safety profile and promising efficacy | ||
| 520 | |a TRIAL REGISTRATION: NCT02592707. Registered October 30, 2015 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Dosimetry | |
| 650 | 4 | |a Neuroendocrine tumours | |
| 650 | 4 | |a Pharmacokinetics | |
| 650 | 4 | |a Somatostatin receptor antagonist | |
| 650 | 4 | |a Systemic radionuclide therapy | |
| 650 | 4 | |a [177Lu]Lu-satoreotide tetraxetan | |
| 700 | 1 | |a Eberlein, Uta |e verfasserin |4 aut | |
| 700 | 1 | |a Ansquer, Catherine |e verfasserin |4 aut | |
| 700 | 1 | |a Beauregard, Jean-Mathieu |e verfasserin |4 aut | |
| 700 | 1 | |a Durand-Gasselin, Lucie |e verfasserin |4 aut | |
| 700 | 1 | |a Grønbæk, Henning |e verfasserin |4 aut | |
| 700 | 1 | |a Haug, Alexander |e verfasserin |4 aut | |
| 700 | 1 | |a Hicks, Rodney J |e verfasserin |4 aut | |
| 700 | 1 | |a Lenzo, Nat P |e verfasserin |4 aut | |
| 700 | 1 | |a Navalkissoor, Shaunak |e verfasserin |4 aut | |
| 700 | 1 | |a Nicolas, Guillaume P |e verfasserin |4 aut | |
| 700 | 1 | |a Pais, Ben |e verfasserin |4 aut | |
| 700 | 1 | |a Volteau, Magali |e verfasserin |4 aut | |
| 700 | 1 | |a Wild, Damian |e verfasserin |4 aut | |
| 700 | 1 | |a McEwan, Alexander |e verfasserin |4 aut | |
| 700 | 1 | |a Lassmann, Michael |e verfasserin |4 aut | |
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