Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined with the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).
Trial Parameters
Brief Summary
Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)
Eligibility Criteria
Inclusion Criteria: * 18 months - 18 years of age at the time of the initial diagnosis. * ≥ 3 years at the moment of inclusion in the trial. * Diagnosis: relapsed/refractory solid tumours with positive uptake on SSTR-PET (PET-CT or PET-MRI), performed in the previous three months before entering the study. The positiveness of the study in patients with localized CNS tumours that do not spread through the spine, will be assessed according to: * Active uptake: when the tumoral lesion shows SSTR expression higher than the one of the background cerebral uptake. * Negative uptake: when the tumoral lesion shows no SSTR expression. Patients with active uptake in the majority of the tumoral lesions will be considered to have a positive SSTR-PET and will be therefore eligible for the trial. For the rest of the patients, the evaluation of SSTR expression will be classified according to a qualitative 4-point scale: SSTR expression V (visual score): * Score = 0: Below or equal to blood pool * Scor