Neuroendocrine Neoplasm, Neuroendocrine Tumor Grade 1, Neuroendocrine Tumor Grade 2, Neuroendocrine Tumors
Conditions
Keywords
Peptide Receptor Radionuclide Therapy, PRRT, Lutetium, DOTATATE
Brief summary
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.
Detailed description
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.
Interventions
Timing of LA-SSA injection prior to PRRT (either 4-6 weeks or 1-7 days).
Sponsors
Neuroendocrine Tumor Research Foundation
The Netherlands Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years; * Able to provide spoken and written informed consent for the trial; * Histopathological confirmed neuroendocrine tumor; * Fulfill the clinical criteria for PRRT; * At least one soft tissue lesion \> 2 cm; * Aimed administered activity of 7400 MBq; * ECOG score (performance status) 0-2.
Exclusion criteria
* Not possible to discontinue LA-SSA for 4-6 weeks; * Use of short-acting SSAs; * Pregnancy and lactating female patients; * Inability to comply to the study procedures; * Factors that might affect the biodistribution (for example, indication for furosemide directly after PRRT infusion, limited fluid intake, any renal catheters, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of continued LA-SSA use on the absorbed dose in tumor lesions during PRRT. | SPECT/CT after 4h, 24h, and 5-7 days post-injection |
Secondary
| Measure | Time frame |
|---|---|
| Effect of continued LA-SSA use on the absorbed dose in normal tissues during PRRT. | 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. | 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. | Blood samples at 2h, 4h, 24h and 5-7 days post-injection |
Other
| Measure | Time frame |
|---|---|
| HRQoL assessments | At baseline, on the day of PRRT administration, 3 weeks after PRRT |
Countries
Netherlands
Outcome results
None listed