Trials / Recruiting
RecruitingNCT06855095
Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- Sponsor
- The Netherlands Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Neuroendocrine Tumors
- Neuroendocrine Tumor Grade 1
- Neuroendocrine Tumor Grade 2
- Neuroendocrine Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Somatostatin analog | Timing of LA-SSA injection prior to PRRT (either 4-6 weeks or 1-7 days). |
Timeline
- Start date
- 2024-06-25
- Primary completion
- 2027-01-01
- Completion
- 2027-03-01
- First posted
- 2025-03-03
- Last updated
- 2025-03-03
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT06855095. Inclusion in this directory is not an endorsement.