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2024-517240-62-00RecruitingPhase 2

Dosimetry based PRRT versus standard dose PRRT with Lu-177-DOTATOC in NEN patients- a randomized study; a step towards tailored PRRT.

Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

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Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
100 (estimated)
First submitted
11 Oct 2024
Start date
4 Nov 2024
Lead sponsor
Region Midtjylland
EU CT number
2024-517240-62-00
EudraCT number
2019-002450-23

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 100
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

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

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Region MidtjyllandAarhus NDenmarkRecruiting

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