Characterizing Gastroenteropancreatic Neuroendocrine Tumors Treated With Targeted Radionuclide Therapy
Multi-modal Characterisation of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort
This study is trying to see if advanced imaging can help doctors choose the right patients for a specific cancer treatment for gastroenteropancreatic neuroendocrine tumors to improve their chances of success.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | radiation |
| Locations | 5 sites (Clichy and 4 other locations) |
| Trial ID | NCT06256705 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed unresectable GEP-NETs that are metastatic and progressive.
Not a fit: Patients who are pregnant, breastfeeding, or have known hypersensitivity to the treatment components will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with GEP-NETs.
How similar studies have performed: Other studies utilizing advanced imaging and targeted therapies have shown promise, but this specific approach is novel in its comprehensive integration of AI and imaging data for GEP-NETs.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clichy and 4 other locations
- Médecine nucléaire et Biophysique - Beaujon — Clichy, France (Recruiting)
- Pancréatologie et Oncologie Digestive - Beaujon — Clichy, France (Recruiting)
- Hépato-gastro-entérologie, cancérologie digestive et assistance nutritionnelle - CHU Nantes — Nantes, France (Active_not_recruiting)
- Médecine nucléaire - CHU Nantes — Nantes, France (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.