According to current guidelines, patients have to withhalt long-acting somatostatin analogues (LA-SSA) for 4-6 weeks prior to every 177Lutetium-DOTATATE administration. The primary objective of the study is to investigate the effect of LA-SSA on the absorbed dose in tumor lesions during PRRT.
The study population includes all patients aged over 18 with a neuroendocrine tumor grade I and II and a clinical indication for PRRT. Patients treated for at least three months with LA-SSA are randomized over two interventional arms: one arm where patients discontinue LA-SSA 4-6 weeks before the first PRRT treatment and one arm where patients continue LA-SSA treatment and receive the first PRRT administration within one week after the most recent LA-SSA injection. Patients in the control arm who have not been treated with LA-SSA in the last three months will start PRRT according to standard local protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Timing of LA-SSA injection prior to PRRT (either 4-6 weeks or 1-7 days).
Antoni van Leeuwenhoek
Amsterdam, Netherlands
RECRUITINGEffect of continued LA-SSA use on the absorbed dose in tumor lesions during PRRT.
Time frame: SPECT/CT after 4h, 24h, and 5-7 days post-injection
Effect of continued LA-SSA use on the absorbed dose in normal tissues during PRRT.
Time frame: SPECT/CT after 4h, 24h, and 5-7 days post-injection and blood samples at 2h, 4h, 24h and 5-7 days post-injection
Effect of continued LA-SSA use on the tumor-to-background ratio.
Time frame: SPECT/CT after 4h, 24h, and 5-7 days post-injection
Effect of continued LA-SSA use on population pharmacokinetic parameters of [177Lu]Lu-HA-DOTATATE.
Time frame: Blood samples at 2h, 4h, 24h and 5-7 days post-injection
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