Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Netherlands
Antoni van Leeuwenhoek
RECRUITING
Amsterdam
Time Frame
Start Date: 2024-06-25
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 39
Treatments
No_intervention: Control
In this arm, patients without any LA-SSA treatment for at least 3 months prior to PRRT are included.
Active_comparator: 2A - LA-SSA injection 4-6 weeks before PRRT
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.
Experimental: 2B - LA-SSA injection 1-7 days before PRRT
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.
Related Therapeutic Areas
Sponsors
Leads: The Netherlands Cancer Institute
Collaborators: Neuroendocrine Tumor Research Foundation