Clinical trial NCT06855095: Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial
Official title: Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Neuroendocrine Tumors
Neuroendocrine Tumor Grade 1
Neuroendocrine Tumor Grade 2
Neuroendocrine Neoplasm
Keywords: Peptide Receptor Radionuclide Therapy
PRRT
Lutetium
DOTATATE
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: Neuroendocrine Tumor Research Foundation
First posted: 2025-03-03
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Effect of continued LA-SSA use on the absorbed dose in tumor lesions during PRRT.
timeFrame: SPECT/CT after 4h, 24h, and 5-7 days post-injection
Secondary outcomes:
measure: Effect of continued LA-SSA use on the absorbed dose in normal tissues during PRRT.
timeFrame: SPECT/CT after 4h, 24h, and 5-7 days post-injection and blood samples at 2h, 4h, 24h and 5-7 days post-injection
measure: Effect of continued LA-SSA use on the tumor-to-background ratio.
timeFrame: SPECT/CT after 4h, 24h, and 5-7 days post-injection
measure: Effect of continued LA-SSA use on population pharmacokinetic parameters of [177Lu]Lu-HA-DOTATATE.
timeFrame: Blood samples at 2h, 4h, 24h and 5-7 days post-injection
Other outcomes:
measure: HRQoL assessments
timeFrame: At baseline, on the day of PRRT administration, 3 weeks after PRRT
Locations:
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
Study officials:
References: