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Clinical Trial · NCT03691064
Post-Authorization Long-Term Safety Study of LUTATHERA
Overview
Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).
Contacts
Study Director (STUDY_DIRECTOR)
ClinicalTrials.gov
NCT03691064Drug / Compound
DOTATATE
Isotope(s):
LUTETIUM-177
Radioisotope: Lu-177
Theranostic Role: Therapeutic Agent & SPECT Imaging
T1/2 (Half-Life): 6.7 Days
Decay Mode: BETA, GAMMA
Energy: Eβeta max 497 keV, Gamma 113-208 keV
Range: In Tissue: 0.25-2mm
Decay Daughters: Hf177
Status: FDA Approvals: PLUVICTO® (2022), LUTATHERA® (2017)
Target(s):
- SSTR2
Ligand Class: Peptides
Chelator: DOTA
Eligibility
Inclusion
- with unresectable or metastatic, well-differentiated, somatostatin receptor positive GEP-NETs
- and who were treated with Lutathera (regardless of the quantity and number of doses administered and whatever the reasons for ending).
Exclusion
- presence of kidney failure with creatinine clearance \< 30 mL/min.
- presence of established or suspected pregnancy or pregnancy not excluded,
- Hypersensitivity to Lutathera (active substance or any of the excipients),
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