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Brief Title: 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma
Official Title: A Phase II Trial of 177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma
Study ID: NCT04903899
Brief 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.
Detailed Description:
Minimum Age: 18 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Rigshospitalet, Copenhagen, , Denmark
Vilnius University Hospital, Vilnius, , Lithuania
Princess Maxima Center for Pediatric Oncology, Utrecht, , Netherlands
Oslo University Hospital, Rikshospitalet, Oslo, , Norway
Karolinska University Hospital, Stockholm, , Sweden
Name: Jakob Stenman, MD PhD
Affiliation: Karolinska University Hospital
Role: STUDY_CHAIR