Investigating the impact of somatostatin analogues on tumor dose during radionuclide therapy
Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial
This study is testing if stopping or continuing long-acting somatostatin treatment affects how well radionuclide therapy works for adults with neuroendocrine tumors.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06855095 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate how long-acting somatostatin analogues (LA-SSA) affect the absorbed dose in tumor lesions during peptide receptor radionuclide therapy (PRRT) for patients with neuroendocrine tumors. Patients aged over 18 with confirmed neuroendocrine tumors are randomized into two groups: one that discontinues LA-SSA prior to PRRT and another that continues LA-SSA treatment. The study will assess the effectiveness of these approaches in improving treatment outcomes. The trial is conducted in collaboration with the Neuroendocrine Tumor Research Foundation at the Netherlands Cancer Institute.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histopathologically confirmed neuroendocrine tumors who have been treated with LA-SSA for at least three months.
Not a fit: Patients unable to discontinue LA-SSA for the required duration or those with short-acting SSA usage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize treatment protocols for neuroendocrine tumors, potentially improving patient outcomes.
How similar studies have performed: Other studies have explored the effects of somatostatin analogues in similar contexts, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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.).
Where this trial is running
Amsterdam
- Antoni van Leeuwenhoek — Amsterdam, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.