LUTETIUM (177LU) EDOTREOTIDE for Neuroendocrine tumor

Inclusion criteria

• {"criterion_text":"- 1.\tMale or female patients > 18 years of age\n- 2.\tNEN confirmed by histology\n- 3.\tClinical, PET/CT or CT proven progression despite standard treatment with somatostatin analogues, targeted therapy (Everolimus, sunitinib), chemotherapy (STZ/5-FU, temozolomide/capecitabine) OR intolerable side effects caused by these standard treatment OR unmanageable carcinoid symptoms\n- 4.\tWHO/ ECOG Performance Status of 0-2\n- 5.\tLife expectancy >6 months\n- 6.\tUptake higher than liver in primary tumor or metastases on Ga-DOTATOC PET/CT (Krenning 3 or 4), if the scan is more than 3 months old at inclusion time, a new scan should be done.\n- 7.\tAdequate organ function as defined by: •\tAdequate kidney function: Patient glomerular filtration rate >30 ml/min measured by Tc-DTPA clearance •\tAdequate bone marrow function: • WBC ≥ 2.0 x 109/L • Platelets ≥ 100 x 109/L • Hb ≥ 6 mmol/l (≥9.67 g/dL)\n- 8.\tWillingness and ability to comply with scheduled visits for SPECT/CT scans, treatment plans, laboratory tests and other study procedures.\n- 9.\tWritten informed consent obtained prior to any screening procedures"}

Exclusion criteria

• {"criterion_text":"- 1.\tTumor amenable to surgery and/or radiofrequency ablation\n- 2.\tPatients who are unable to stay isolated for 24 hours\n- 3.\tPrevious PRRT\n- 4.\tFemale patients who are pregnant or lactating. Women who are of childbearing potential (defined as all women physiologically capable of becoming pregnant) have to practice an effective method of contraception/birth control. Fertile female patients have to take a urinary pregnancy test, to ensure that they are not pregnant, before they can enter the study. After entering the study, they have to use effective contraception during the study period and 6 months after. Effective contraception methods include: •\tUse of oral, injected or implanted hormonal methods of contraception or •\tPlacement of an intrauterine device (IUD) or intrauterine system (IUS) •\tTotal abstinence or patient sterilization (male or female)\n- 5.\tMale patients are not allowed to conceive pregnancy for 6 months after last treatment cycle\n- 6.\tKnown to be hypersensitive to any component of the Lu-177-DOTATOC\n- 7.\tPatients with meningioma"}

Primary endpoints

• {"endpoint_text":"- •\tDifference in progression free survival between NEN patients treated with dosimetry based versus standard PRRT. Defined as time from randomization to documented disease progression or death by any cause, evaluated by CT, RECIST 1.1.","definition_or_measurement_approach":"Defined as time from randomization to documented disease progression or death by any cause, evaluated by CT, RECIST 1.1."}

Secondary endpoints

• {"endpoint_text":"- •\tDifference in tumor dose between dosimetry based and standard PRRT treatment groups\n- •\tDifference in kidney toxicity between dosimetry based and standard PRRT treatment groups, measured by creatine, eGFR, cystatin-c, Tc-DTPA clearance, and kidney fibrosis markers PRO-6, C3M and LAMC1.\n- •\tDifference in bone marrow function between dosimetry based and standard PRRT treatment groups, measured by hemoglobin, white blood cells, platelets.\n- •\tDifference in subjective side effects between dosimetry bas","definition_or_measurement_approach":"Tumor dose difference (no further measurement detail provided). Kidney toxicity measured by creatinine, eGFR, cystatin-c, Tc-DTPA clearance and kidney fibrosis markers PRO-6, C3M and LAMC1. Bone marrow function measured by haemoglobin, white blood cells and platelets. The last item ('Difference in subjective side effects between dosimetry bas') is truncated in source and no measurement approach provided."}

Denmark

Earliest CTIS Part Ii Submission Date

25-10-2024

Latest Decision Or Authorization Date

04-11-2024

Processing Time Days

10

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"","organisation_type":"Educational Institution"}