RecruitingPhase 2Phase 3NCT06855095
Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial
Sponsor
The Netherlands Cancer Institute
Enrollment
39 participants
Start Date
Jun 25, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria5
- 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.).
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Interventions
DRUGSomatostatin analog
Timing of LA-SSA injection prior to PRRT (either 4-6 weeks or 1-7 days).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06855095
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