OCTREOTIDE for Neuroendocrine tumor (grade I-II)

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Able to provide spoken and written informed consent for the trial"}
• {"criterion_text":"- Histopathological confirmed neuroendocrine tumor"}
• {"criterion_text":"- Fulfill the clinical criteria for PRRT"}
• {"criterion_text":"- At least one soft tissue lesion > 2 cm"}
• {"criterion_text":"- Aimed administered activity of 7400 MBq"}
• {"criterion_text":"- ECOG score (performance status) 0-2"}

Exclusion criteria

• {"criterion_text":"- Not possible to discontinue LA-SSA for 4-6 weeks"}
• {"criterion_text":"- Use of short-acting somatostatin analogues"}
• {"criterion_text":"- Inability to comply to the study procedures"}
• {"criterion_text":"- Factors that might affect the biodistribution (for example, indication for furosemide directly after PRRT infusion, limited fluid intake, any renal catheters, etc.)"}
• {"criterion_text":"- Pregnancy and lactating female patients"}

Primary endpoints

• {"endpoint_text":"- The absorbed dose in target lesions measured on SPECT/CT imaging","definition_or_measurement_approach":"Measured on SPECT/CT imaging"}

Secondary endpoints

• {"endpoint_text":"- The absorbed dose in normal tissue (kidneys, liver, spleen) measured on SPECT/CT imaging","definition_or_measurement_approach":"Measured on SPECT/CT imaging in kidneys, liver, spleen"}
• {"endpoint_text":"- The bone marrow dose is determined using blood withdrawals and SPECT/CT imaging","definition_or_measurement_approach":"Determined using blood withdrawals and SPECT/CT imaging"}
• {"endpoint_text":"- The uptake on SPECT/CT between target lesions and the liver and spleen measured on the 24 hours’ time point","definition_or_measurement_approach":"Measured on SPECT/CT at the 24-hour time point (target lesions vs liver and spleen)"}
• {"endpoint_text":"- The effect of continued LA-SSA use on specific population pharmacokinetic parameters will be qualified using population pharmacokinetic modelling using the acquired SPECT/CT scans and blood samples for dosimetry","definition_or_measurement_approach":"Population pharmacokinetic modelling using acquired SPECT/CT scans and blood samples for dosimetry"}

Netherlands

Earliest CTIS Part Ii Submission Date

12-12-2023

Latest Decision Or Authorization Date

03-10-2024

Processing Time Days

296

Number Of Sites

1

Number Of Participants

34

Primary sponsor

Full Name

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Neuroendocrine tumor research foundation (NETRF)","duties_or_roles":"","organisation_type":""}