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

PHASE2RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 19, 2021

Primary Completion Date

May 20, 2026

Study Completion Date

May 20, 2031

Conditions
Neuroblastoma RecurrentNeuroblastoma
Interventions
COMBINATION_PRODUCT

177Lu-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.

Trial Locations (5)

DK-2100

RECRUITING

Rigshospitalet, Copenhagen

LT-08406

RECRUITING

Vilnius University Hospital, Vilnius

NL-3584

RECRUITING

Princess Maxima Center for Pediatric Oncology, Utrecht

NO-0372

RECRUITING

Oslo University Hospital, Rikshospitalet, Oslo

SE-171 76

RECRUITING

Karolinska University Hospital, Stockholm

All Listed Sponsors
collaborator

Advanced Accelerator Applications

INDUSTRY

collaborator

Novartis

INDUSTRY

lead

Jakob Stenman

OTHER