Characterizing Gastroenteropancreatic Neuroendocrine Tumors Treated With Targeted Radionuclide Therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to improve the management of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) by utilizing advanced imaging techniques and data analysis to enhance patient selection for targeted radionuclide therapy (PRRT). It will involve a large prospective cohort of patients undergoing simultaneous 68Ga-DOTATOC PET-MRI imaging to identify predictive markers of treatment effectiveness. The research will focus on integrating clinical, molecular, and imaging data to uncover relevant predictive signatures that could lead to better treatment outcomes. The study seeks to address current limitations in patient stratification and early identification of responders to PRRT.

Why it matters

Who can join: the full rules

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

Where it's running

• Médecine nucléaire et Biophysique - Beaujon
  Clichy, France Recruiting
• Pancréatologie et Oncologie Digestive - Beaujon
  Clichy, France Recruiting
• Médecine nucléaire - CHU Nantes
  Nantes, France Recruiting
• Hépato-gastro-entérologie, cancérologie digestive et assistance nutritionnelle - CHU Nantes
  Nantes, France Active not recruiting
• Service de Médecine Nucléaire, Groupe Hospitalier Bichat-Claude Bernard
  Paris, France Active not recruiting

Study contacts

• Study coordinator: Catherine ANSQUER
• Email: catherine.ansquer@chu-nantes.fr
• Phone: 00-33-2-40-08-41-36

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.