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A phase II trial of 177Lutetium-DOTATATE in children with primary refractory or relapsed high-risk neuroblastoma LuDO-N

Status
Suspended
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503684-42-00
Acronym
LuDO-N
Enrollment
31
Registered
2023-05-05
Start date
2021-01-12
Completion date
Unknown
Last updated
2024-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroblastoma

Brief summary

Response by the Revised International Neuroblastoma Response Criteria (INRC) at 1 month after the completion of therapy

Detailed description

Response based on 68Ga-DOTATOC PET/CT imaging at 1 and 4 months after completion of therapy in measurable target lesions, Response based on 123I-mIBG SPECT/CT imaging (when available) at 1 and 4 months after completion of therapy in measurable target lesions, Response by the Revised INRC criteria at 4 months after the completion of therapy, Progression free survival (PFS), Overall survival (OS), Hematological and renal toxicity according to CTCAE 5.0

Interventions

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Response by the Revised International Neuroblastoma Response Criteria (INRC) at 1 month after the completion of therapy

Secondary

MeasureTime frame
Response based on 68Ga-DOTATOC PET/CT imaging at 1 and 4 months after completion of therapy in measurable target lesions, Response based on 123I-mIBG SPECT/CT imaging (when available) at 1 and 4 months after completion of therapy in measurable target lesions, Response by the Revised INRC criteria at 4 months after the completion of therapy, Progression free survival (PFS), Overall survival (OS), Hematological and renal toxicity according to CTCAE 5.0

Countries

Denmark, Lithuania, Netherlands, Norway, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026