Operandi project aims to address unmet clinical needs in the current management of GEP-NETs treated with PRRT by exploring new opportunities provided by imaging-based (AI algorithms) and data augmentation, simultaneous 68Ga-DOTATOC PET-MRI imaging, and novel approaches to increase patient selection and PRRT efficacy (genomic profiling, radiopotentiators, and new radionuclides). The study aim to identify predictive and early markers indicative of PRRT effectiveness based on a large prospective cohort of GEP-NET patients. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous 68Ga-DOTATOC PET-MRI.
Considering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic PET-MRI at baseline, at mid course of PRRT and 1 year after PRRT initiation, in patients with advanced GEP-NETs treated with PRRT.
According the MDT decision to refer to PRRT
Histologically confirmed diagnosis of unresectable GEP-NETs whatever the grade or NETs of unknown primary but suspected of GEP origin
Metastastic and progressive according RECIST 1.1 criteria
At least 1 measurable site of disease per RECIST v1.1 using contrast-enhanced CT or magnetic resonance imaging
Known pregnancy or breastfeeding women
Known hypersensitivity to 177Lu, octreotate, DOTA, 68Ga, Edotreotide,
Known hypersensitivity to lysine, arginine, or any excipient of the nephroprotective amino acid solution (AAS) given concomitantly to the 177Lu-DOTATATE infusion.
Contraindication to MRI and technical impossibility of MRI
Single group
Simultaneous 68Ga-DOTATOC PET-MRI
Other interventionon month before first cycle of 177Lu-DOTATATE, after second cycle and one year after first cycle
Clinical response defined by the PFS as the time measured from the day of first administration of PRRT to first progression or death at 18 months, whichever occurs first
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