NCT06256705Recruiting
Multi-modal Characterisation of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort
Source: ClinicalTrials.gov · Last updated 22 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 5 Feb 2024
- Start date
- 25 Mar 2024
- Primary completion date
- 25 Mar 2028
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT06256705
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 25 Mar 2024 to the primary completion date, 25 Mar 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior external beam radiation therapy (EBRT) of GEP-NET lesions or liver selective internal radiation therapy within 12 weeks before inclusion, if extensive
- 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
- Prior peptide receptor radionuclide therapy (PRRT)
Other illness
- 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.
- NYHA 3 or 4 heart failure
- Other progressive cancer excluding in situ cervical cancer and basal or squamous cell skin cancer within the last 3 years
Lab values
- 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
Other
- Known pregnancy or breastfeeding women
- Contraindication to MRI and technical impossibility of MRI
- 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
- 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
Who the study is looking for
- 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
- SSTR+ disease, as evidenced by PET-DOTATOC performed within 4 months prior to inclusion (lesion uptake greater than liver physiological uptake)
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Médecine nucléaire et Biophysique - Beaujon Coordinator of this site? Confirm its status | Clichy | France | Recruiting |
| Pancréatologie et Oncologie Digestive - Beaujon Coordinator of this site? Confirm its status | Clichy | France | Recruiting |
| Hépato-gastro-entérologie, cancérologie digestive et assistance nutritionnelle - CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Active, not recruiting |
| Médecine nucléaire - CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Service de Médecine Nucléaire, Groupe Hospitalier Bichat-Claude Bernard Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.