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New treatment option for Gastroenteropancreatic Neuroendocrine Tumor
Official title Multi-modal Characterisation of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort
ClinicalTrials.gov ID: NCT06256705
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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...
- 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...
- Other systemic antitumor treatment (non-radioactive, excluding somatostatin analogues) not interrupted for at least 4 weeks
See the full eligibility criteria
- 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
- 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 \ 30g/L
- Albumin \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Clichy, France
- Nantes, France
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clichy, France; Nantes, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.