Clinical trial · Interventional
Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial
NCT06855095CI-TRIAL-00086693ATSArecruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Neoplasm | Neuroendocrine Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neuroendocrine Tumor Grade 1 | Neuroendocrine Tumor G1 | ALIAS | 0.90 |
| Neuroendocrine Tumor Grade 2 | Neuroendocrine Tumor G2 | ALIAS | 0.90 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Somatostatin analog | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Control
- description
- In this arm, patients without any LA-SSA treatment for at least 3 months prior to PRRT are included.
- type
- ACTIVE_COMPARATOR
- label
- 2A - LA-SSA injection 4-6 weeks before PRRT
- description
- In this arm, patients on LA-SSA treatment for at least 3 months prior to PRRT are included and will receive the last LA-SSA injection 4-6 weeks before PRRT.
- interventionNames
- Drug: Somatostatin analog
- type
- EXPERIMENTAL
- label
- 2B - LA-SSA injection 1-7 days before PRRT
- description
- In this arm, patients on LA-SSA treatment for at least 3 months prior to PRRT are included and will receive the last LA-SSA injection 4-6 weeks before PRRT.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.).
References
Publications (0)
Data not yet available
No reference posted for this study.