Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Somatostatin analog.
- Who it may be relevant to
- Registry conditions: Neuroendocrine Tumors, Neuroendocrine Tumor Grade 1, Neuroendocrine Tumor Grade 2, Neuroendocrine Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Somatostatin analog
Timing of LA-SSA injection prior to PRRT (either 4-6 weeks or 1-7 days).
Primary outcome measures
- Effect 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]
Secondary outcome measures (3)
- 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]
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.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Antoni van Leeuwenhoek — Amsterdam
Identifiers
NCT: NCT06855095 · N23PRR