Dosimetry based PRRT versus standard dose PRRT with Lu-177-DOTATOC in NEN patients- a randomized study; a step towards tailored PRRT.
Key facts
- Where
- Aarhus N, DániaSee the site
- Phase
- 2. fázis
Where in Dánia
- Region MidtjyllandAarhus N, DániaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Midtjylland
- Trial code
- EU 2024-517240-62-00
- Record updated
- 2024. november 4.
- Original description
To investigate is it is better for patients with NET to receive dosimetry based PRRT compared to standard dose PRRTRead full original descriptionShow less
To investigate is it is better for patients with NET to receive dosimetry based PRRT compared to standard dose PRRT
Inclusion: Male or female patients > 18 years of age 2. NEN confirmed by histology 3. Clinical, 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 4. WHO/ ECOG Performance Status of 0-2 5. Life expectancy >6 months 6. Uptake 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. 7. Adequate organ function as defined by: • Adequate kidney function: Patient glomerular filtration rate >30 ml/min measured by Tc-DTPA clearance • Adequate bone marrow function: • WBC ≥ 2.0 x 109/L • Platelets ≥ 100 x 109/L • Hb ≥ 6 mmol/l (≥9.67 g/dL) 8. Willingness and ability to comply with scheduled visits for SPECT/CT scans, treatment plans, laboratory tests and other study procedures. 9. Written informed consent obtained prior to any screening procedures.
Exclusion: Tumor amenable to surgery and/or radiofrequency ablation 2. Patients who are unable to stay isolated for 24 hours 3. Previous PRRT 4. Female 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: • Use of oral, injected or implanted hormonal methods of contraception or • Placement of an intrauterine device (IUD) or intrauterine system (IUS) • Total abstinence or patient sterilization (male or female) 5. Male patients are not allowed to conceive pregnancy for 6 months after last treatment cycle 6. Known to be hypersensitive to any component of the Lu-177-DOTATOC 7. Patients with meningioma.