Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-25 @ 3:24 AM
NCT ID:
NCT06256705
Eligibility Criteria:
Inclusion Criteria:
* According the MDT decision to refer to PRRT
1. Histologically confirmed diagnosis of unresectable GEP-NETs whatever the grade or NETs of unknown primary but suspected of GEP origin
2. Metastastic and progressive according RECIST 1.1 criteria
3. At least 1 measurable site of disease per RECIST v1.1 using contrast-enhanced CT or magnetic resonance imaging
4. SSTR+ disease, as evidenced by PET-DOTATOC performed within 4 months prior to inclusion (lesion uptake greater than liver physiological uptake)
5. The majority of the lesions and all RECIST 1.1 selected target lesion have to be SSTR+.
* Karnofsky performance status scale ≥ 60
* Live expectancy \>6 months
* Patients ≥ 18 years of age
Exclusion Criteria:
* 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
* Prior external beam radiation therapy (EBRT) of GEP-NET lesions or liver selective internal radiation therapy within 12 weeks before inclusion, if extensive
* Other systemic antitumor treatment (non-radioactive, excluding somatostatin analogues) not interrupted for at least 4 weeks
* Mixed Neuroendocrine-Non-endocrine Neoplasms (MiNEN)
* Neuroendocrine carcinoma
* Uncontrolled brain metastasis for at least 3 months
* NYHA 3 or 4 heart failure
* Inability to discontinue delayed-acting somatostatin analogues at least 28 days prior the PRRT or rapid-acting somatostatin analogues at least 24 hours prior the PRRT
* Non-adequate bone marrow, liver and renal function within 1 month prior the PRRT as assessed by the following laboratory tests:
* Platelet count \< 75,000/mm3
* Haemoglobin ≤ 8,0 g/dL
* Total bilirubin \> 3 ULN
* Neutrophils \< 1000/mm3
* Prothrombin time \< 70% unless albumin \> 30g/L
* Albumin \<30g/L unless prothrombin time \> 70 %
* Glomerular Filtration Rate (GFR) \< 35 mL/min/1.73 m2
* Prior peptide receptor radionuclide therapy (PRRT)
* Other progressive cancer excluding in situ cervical cancer and basal or squamous cell skin cancer within the last 3 years
* Patient refusal to give written informed consent
* Subject deprived of freedom, subject under a legal protective measure
* No affiliation to a social security regimen or CMU
* Patient under State Medical Aid
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06256705
Study Brief:
Protocol Section:
NCT06256705