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Taking people in DenmarkPhase 2

Personalized versus standard radioligand treatment for neuroendocrine tumors using Lu-177-DOTATOC

Compares dose-tailored and standard-dose Lu-177-DOTATOC treatment in adults with neuroendocrine tumors.

Key facts

Who runs it
Region Midtjylland
Where
Aarhus N, DenmarkSee the site
Registry title
Dosimetry based PRRT versus standard dose PRRT with Lu-177-DOTATOC in NEN patients- a randomized study; a step towards tailored PRRT.
Status
Recruiting
Phase
Phase 2
People taking part
100 people, planned
Started
4 Nov 2024
Expected to end
24 Dec 2027
Type of study
Interventional
Record updated
4 November 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a neuroendocrine tumour (NEN) that has grown despite standard treatment and that takes up the scan tracer. It compares a dose of radioactive treatment (Lu-177-DOTATOC) set by dosimetry with a standard dose.

Age
Older than 18 years
Sex
Women and men can join
Disease stage
NEN confirmed by tissue examination. Growth shown by clinical signs, PET/CT or CT despite standard treatment, or intolerable side effects of that treatment, or unmanageable carcinoid symptoms. Tumour uptake higher than liver on Ga-DOTATOC PET/CT (Krenning 3 or 4).
Earlier treatment
Standard treatment must have been tried: somatostatin analogues, targeted therapy (Everolimus, sunitinib) or chemotherapy (STZ/5-FU, temozolomide/capecitabine). Earlier PRRT is not allowed.
Biomarker or test result
Uptake higher than liver in the primary tumour or metastases on Ga-DOTATOC PET/CT (Krenning 3 or 4). A scan older than 3 months must be repeated.

Main reasons for not taking part

  • Tumour that can be treated by surgery or radiofrequency ablation
  • Unable to stay isolated for 24 hours
  • Previous PRRT
  • Pregnant or breastfeeding women
  • Allergy to any part of Lu-177-DOTATOC, or meningioma

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Denmark

  • Region MidtjyllandAarhus N, DenmarkTaking people

About the trial

What the trial wants to find out

To investigate is it is better for patients with NET to receive dosimetry based PRRT compared to standard dose PRRT

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Dosimetry based PRRT versus standard dose PRRT with Lu-177-DOTATOC in NEN patients- a randomized study; a step towards tailored PRRT.
Plain-language title
Personalized versus standard radioligand treatment for neuroendocrine tumors using Lu-177-DOTATOCGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
4 November 2024