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RecruitingNCT04903899LuDO-NUpdated Feb 11, 2025

177Lutetium-DOTATATE in Children with Primary Refractory or Relapsed High-risk Neuroblastoma

A Phase 2 interventional study of 177Lu-DOTATATE in Neuroblastoma Recurrent and Neuroblastoma, sponsored by Jakob Stenman. Recruiting at 5 sites in 5 countries. Open to participants aged 18 Months and older. Per ClinicalTrials.gov, last updated 2025-02-11.

Sponsored by Jakob Stenman · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started May 2021; still recruiting 5 years 4 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Months and older
Sex
All
01

Study summary

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 ende 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.

02

Conditions studied

  • Neuroblastoma Recurrent
  • Neuroblastoma

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03

In context

Neuroblastoma

625 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.

This study's planned enrollment of 24 is below the median of 32 across 475 interventional studies indexed under Neuroblastoma.

Browse Neuroblastoma studies →

Lead sponsor

This is the only study on the registry with Jakob Stenman as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Pathology 1.1. Histologically confirmed diagnosis of neuroblastoma 1.2. Immunohistochemical staining for somatostatin receptors (SSTR) performed from primary tumor tissue when available
  2. Relapsed or primary refractory high-risk neuroblastoma: INSS stage 4 disease or INRGSS stage M disease
  3. Age >18 months at the time of enrolment into this study
  4. Life expectancy of greater than 3 months
  5. Performance Status 5.1. Karnofsky > 50% (for patients > 12 years of age) 5.2. Lansky > 50% (for patients ≤ 12 years of age)
  6. 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
  7. 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
  8. 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
  9. 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
  10. 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 criteria

Exclusion Criteria:

  1. 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.
  2. Pregnant or lactating patient
  3. Concurrent treatment with any anti-tumor agents
  4. Prior treatment with other radiolabeled somatostatin analogues
  5. Hypersensitivity to any component of the investigational drug 177Lutetium-DOTATATE
  6. Treatment with long-acting somatostatin analogues within 30 days, or with short-acting somatostatin analogues within 24 hours prior the administration of 177Lutetium-DOTATATE
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    177Lu-DOTATATE

    A total of two doses of 177Lu-DOTATATE will be administered intravenously. The minimum time between treatments is 2 weeks.

    Combination Product: 177Lu-DOTATATE

Interventions

  • Combination product177Lu-DOTATATE

    A weight-based activity of 200 MBq kg-1 will be used for the first dose. The activity of the second dose will be calculated based on whole body activity scans as well as SPECT CT scans to determine the absorbed kidney dose. The aim is to administer 177Lu-DOTATATE corresponding to a whole-body dose of 1,2 Gy, with a cumulative whole-body dose of about 2,4 Gy over two courses, and not exceeding a cumulative renal dose of 23 Gy, in order to avoid renal toxicity.

06

What researchers measure

Primary outcomes

  1. Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC) - 1 months after End of Treatment

    Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)

    Time frame: 1 months following end of treatment

Secondary outcomes

  1. Number and severity of treatment-related adverse events

    Number and severity of treatment-related adverse events

    Time frame: Up to 5 years after end of treatment

  2. Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC) - 4 months after End of Treatment

    Treatment response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)

    Time frame: 4 months following end of treatment

  3. Progression-free survival

    Time to progress or death, whichever occurs first

    Time frame: Time from registration to progression or death, up to 5 years following end of treatment

  4. Overall survival - up to 5 years after End of Treatment

    Overall survival

    Time frame: Time from registration to the the date of death, up to 5 years following end of treatment

Other outcomes

  1. Tumour dosimetry: absorbed dose per administration of 177Lu-DOTATATE

    Measured by SPECT/CT

    Time frame: At every administered dose of 177Lu-DOTATATE throughout the trial treatment phase (5 years)

  2. Correlation of expression of Somatostatin Receptor-2 (SSTR-2) to uptake on 68Ga-DOTATOC PET/CT

    SSTR-2 expression in the histology samples from primary surgery measured by immunohistochemistry.

    Time frame: Throughout the trial treatment phase (5 years)

  3. Uptake on 68Ga-DOTATOC PET/CT

    Measured by SUVmax (maximum standardized uptake value)

    Time frame: At end of treatment, and 1 and 4 months after end of treatment.

07

Study locations

5 of 5 sites recruiting
  • Rigshospitalet
    Copenhagen, DK-2100, Denmark
    Recruiting
  • Vilnius University Hospital
    Vilnius, LT-08406, Lithuania
    Recruiting
  • Princess Maxima Center for Pediatric Oncology
    Utrecht, NL-3584, Netherlands
    Recruiting
  • Oslo University Hospital, Rikshospitalet
    Oslo, NO-0372, Norway
    • Kirsten Brunsvig Jarvis, MD · Contact · kirjar@ous-hf.no
    • Heidi Knudsen, MD · Contact
    Recruiting
  • Karolinska University Hospital
    Stockholm, SE-171 76, Sweden
    Recruiting
08

References and documents

Publications

  • Sundquist F, Georgantzi K, Jarvis KB, Brok J, Koskenvuo M, Rascon J, van Noesel M, Gryback P, Nilsson J, Braat A, Sundin M, Wessman S, Herold N, Hjorth L, Kogner P, Granberg D, Gaze M, Stenman J. A Phase II Trial of a Personalized, Dose-Intense Administration Schedule of 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-Risk Neuroblastoma-LuDO-N. Front Pediatr. 2022 Mar 10;10:836230. doi: 10.3389/fped.2022.836230. eCollection 2022. PubMed 35359899 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04903899
Lead sponsor
Jakob Stenman
Collaborators
Advanced Accelerator Applications, Novartis
Responsible party
Jakob Stenman (Consultant Pediatric Surgeon, Associate Professor, Karolinska University Hospital) — Sponsor-investigator
First posted
May 27, 2021
Start date
May 19, 2021
Primary completion
May 20, 2026 (estimated)
Completion
May 20, 2031 (estimated)
Last update
Feb 11, 2025

Study contacts

Jakob Stenman, MD PhD
Contact
jakob.stenman@sll.se
(0)51770000 ext. 46
Kleopatra Georgantzi, MD
Contact
kleopatra.georgantzi@sll.se
(0)51770000 ext. 46
Jakob Stenman, MD PhD
study chair · Karolinska University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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