Tests lutetium-DOTATATE in children with relapsed high-risk neuroblastoma
Tests lutetium-DOTATATE treatment in children with returning high-risk neuroblastoma.
Plain-language title generated from the registry record
Registry title: 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma
Key facts
- Where
- Vilnius, LithuaniaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
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 children and adults over 18 months old with high-risk neuroblastoma that did not respond to first treatment or came back. They would receive 2 doses of 177Lu-DOTATATE.
- Age
- Over 18 months, up to 64 years.
- Sex
- All sexes can join.
- Disease stage
- High-risk neuroblastoma that did not respond to first treatment or came back: INSS stage 4 or INRGSS stage M. The diagnosis must be confirmed under the microscope. Life expectancy must be more than 3 months.
- Earlier treatment
- A 2-week break from any earlier treatment is needed, with blood counts recovered and recovery from major surgery. Stored blood stem cells must be available (at least 2 x10^6 CD34+ cells/kg). Earlier radiolabeled somatostatin analogues are not allowed.
- Biomarker or test result
- The 68Ga-DOTATATE PET/CT scan must show uptake in the tumour higher than in the liver. Blood, liver and kidney tests must be within set limits, including kidney filtration rate above 50mL/min/1.73m2.
Main reasons for not taking part
- Pregnant or breastfeeding
- Taking any other anti-tumour treatment at the same time
- Earlier treatment with radiolabeled somatostatin analogues
- Allergy to any component of 177Lutetium-DOTATATE
- Swelling of a kidney from blocked urine flow (hydronephrosis) on baseline imaging, unless a blockage is ruled out
Read by machine on 12 November 2026.
Where in Lithuania
- Vilniaus universiteto ligonine Santaros klinikos VšĮVilnius, LithuaniaTaking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Jakob Stenman
- Trial code
- NCT04903899EU 2023-503684-42-00
- Record updated
- 9 November 2026
- Original description
The LuDO-N Trial is a multi-centre phase II clinical trial on 177Lu-DOTATATE treatment of recurrent or relapsed high-risk neuroblastoma in children. The LuDO-N Trial builds on the experience from the previous LuDO Trial and utilises an intensified dosing schedule to deliver 2 doses over a 2-week period, in order to achieve a maximal effect on the often rapidly progressing disease. This strategy requires a readiness for autologous stem cell transplantation in all patients, but is not anticipated to increase the risk of long-term sequelae, since the cumulative radiation dose remains unchanged. The primary aim of the study is to assess the response to 177Lu-DOTATATE treatment at 1 and 4 months after end of treatment. Secondary aims are to assess survival and treatment-related toxicity. Additional aim are to correlate tumour dosimetry with response, correlate SSTR-2 expression with 68Ga-DOTATATE uptake and to correlate the uptake with the treatment response.Read full original descriptionShow less
A Phase II Trial of 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma
The LuDO-N Trial is a multi-centre phase II clinical trial on 177Lu-DOTATATE treatment of recurrent or relapsed high-risk neuroblastoma in children. The LuDO-N Trial builds on the experience from the previous LuDO Trial and utilises an intensified dosing schedule to deliver 2 doses over a 2-week period, in order to achieve a maximal effect on the often rapidly progressing disease. This strategy requires a readiness for autologous stem cell transplantation in all patients, but is not anticipated to increase the risk of long-term sequelae, since the cumulative radiation dose remains unchanged. The primary aim of the study is to assess the response to 177Lu-DOTATATE treatment at 1 and 4 months after end of treatment. Secondary aims are to assess survival and treatment-related toxicity. Additional aim are to correlate tumour dosimetry with response, correlate SSTR-2 expression with 68Ga-DOTATATE uptake and to correlate the uptake with the treatment response.
Inclusion: Pathology 1.1. Histologically confirmed diagnosis of neuroblastoma 1.2. Immunohistochemical staining for somatostatin receptors (SSTR) performed from primary tumor tissue when available; Relapsed or primary refractory high-risk neuroblastoma: INSS stage 4 disease or INRGSS stage M disease; Age >18 months at the time of enrolment into this study; Life expectancy of greater than 3 months; Performance Status 5.1. Karnofsky > 50% (for patients > 12 years of age) 5.2. Lansky > 50% (for patients ≤ 12 years of age); Prior treatment 6.1. Two-week washout from any prior treatment 6.2. Patients must have recovery of hematological toxicity following previous therapy 6.3. Adequate recovery from major surgery prior to receiving study treatment; Diagnostic imaging 7.1. Uptake in the primary tumor or metastatic tumour deposits on 68Ga-DOTATATE PET/CT at least higher than the liver uptake and performed within two months prior to registration 7.2. 123I-mIBG scintigraphy to be performed within two months prior to registration 7.3. CT or MRI of the primary tumor and bulky metastatic sites within two months prior to registration; Laboratory requirements to be performed within 7 days prior to commencing trial treatment 8.1. Hematology: 8.1.1. Hemoglobin, If Hb is <120 g/L then patient will receive a blood transfusion prior to commencing trial treatment 8.1.2. Absolute neutrophil count > 1.0 x 109/L 8.1.3. Absolute Platelets > 50 x 109/L 8.2. Biochemistry: 8.2.1. Bilirubin within 1.5 x ULN 8.2.2. ALT within 2.5 x ULN 8.2.3. AST within 2.5 x ULN 8.2.4. GGT within 5 x ULN 8.2.5. ALP within 5 x ULN 8.2.6. Glomerular filtration rate >50mL/min/1.73m2 assessed by a recognised method, such as inulin, 51Cr-EDTA, 99mTc-DTPA or iohexol clearance and performed within 2 months prior to registration 8.2.7. Urinary catecholamine metabolites measured within 2 months prior to registration; Peripheral blood stem cells (PBSC) 9.1. A minimum of 2 x106 CD34+ cells/kg (optimally 6 x106 CD34+ cells/kg) must be available for each study subject prior to registration; Written informed consent from patient and/or parent(s) or legal guardian(s) in accordance with national regulations, prior to registration or any trial-related screening procedures.
Exclusion: Concurrent treatment with any anti-tumor agents; Prior treatment with other radiolabeled somatostatin analogues; Hypersensitivity to any component of the investigational drug 177Lutetium-DOTATATE; Treatment with long-acting somatostatin analogues within 30 days, or with short-acting somatostatin analogues within 24 hours prior the administration of 177Lutetium-DOTATATE; Not fit enough to undergo proposed study treatment, as assessed by national PI, considering precautions defined in the latest version of the 177Lutetium-DOTATATE SmPC; Pregnant or lactating patient; Hydronephrosis in either kidney on baseline MRI or CT; patients can still be eligible for inclusion if urinary tract obstruction can be ruled out by renography.