The LuMEn Trial: 177Lu-octreotate Treatment Outcome Prediction Using Multimodality Imaging in Refractory Neuroendocrine Tumours.
This is a feasibility study evaluating the use of 177Lutetium-octreotate in the treatment of
advanced refractory Neuroendocrine Tumors.
Objectives of the study:
1. primary (on a lesion basis): To assess the value of the following parameters (obtained
through functional and molecular imaging) for predicting the lesion-by-lesion treatment
outcome: 68Ga-octreotate and 18FDG uptake on PET/CT scans as well as apparent diffusion
coefficient on diffusion-weighted magnetic resonance imaging (absolute values at
baseline and after each cycle and their relative differences) and post 177Lu-octreotate
SPECT/CT dosimetry after each cycle.
2. secondary (on a patient basis): To generate a patient-based response model based on the
Treatment will consist of 177Lu-octreotate infusions in fixed activities of 7,4 GigaBecqurel
each, given 8-11 weeks apart, injected intravenously with simultaneous infusion of an amino
acid solution. (Before amino acid nephroprotection solution, ondansetron, methylprednisolone
and metoclopramid, are given intravenously in order to prevent nausea or vomiting).
Approximately 30 min after the beginning of the amino acid solution, 177Lu-octreotate is
co-infused over 15-30 minutes. The amino acid infusion is continued at the same rate for 3-5
more hours (total infusion lasts 4-6 hours).
In total, 4 cycles are planned. However, the total number of administered cycles will be
limited by critical organ (kidneys and bone marrow) cumulated absorbed doses.
Treatment efficacy will be assessed:
- on a lesion-basis (change of longest transversal diameter).
- on a patient-basis using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
the difference in the diameter for each target lesion after each cycle of the treatment measured on MRI (or on CT scan if MRI is not applicable)
3 years [Anticipated]
Patrick Flamen, M.D., Ph.D.
Jules Bordet Institute
Belgium: Federal Agency for Medicinal Products and Health Products