NCT03667092Completed
Exploration of Molecular Biomarkers for Lu-177 DOTATATE Therapy in Midgut Neuroendocrine Tumor
Pilot Study for Measuring Molecular Biomarkers and Their Capacity to Characterize Radionuclide Therapy With Lu-177 DOTATATE) in Metastatic G1-G2 Neuroendocrine Midgut Tumors
Source: ClinicalTrials.gov · Last updated 10 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Midgut neuroendocrine tumours present an increasing incidence and poor survival at 5 years with limited therapeutic options for metastatic, non-operable cases. Lu-177 Dotatate, targeting somatostatin receptors, is an internal vectorized radiotherapy using Lu-177, an ideal radionuclide for peptide radionuclide therapy. In NETTER-1 phase III randomized clinical trial, Lu-177 Dotatate proved its superiority in increasing progression free survival for midgut neuroendocrine tumors. This study hypothesize that finding biomarkers of individual radio sensitivity for this type of internal vectorized therapy would allow treatment personalization. The protocol aim at studying transcript variations induced by this therapy.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 47 (actual)
- First submitted
- 27 Jul 2018
- Start date
- 1 Sept 2018
- Primary completion date
- 22 May 2024
- Lead sponsor
- University Hospital, Toulouse
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT03667092
What you commit to
- Study type: Interventional
- Participants enrolled: 47
- From 1 Sept 2018 to the primary completion date, 22 May 2024
- 1 site 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
- Patients on chemotherapy or other targeted therapy within the 4 months preceding peptide receptor radionuclide therapy
- Patients with prior chemotherapy or peptide receptor radionuclide therapy administration
Other illness
- Patients with uncontrollable psychotic disorders
- Renal hepatic and medullary insufficiency
Other
- Fertile patients refusing active contraception ; pregnancy.
Who the study is looking for
- Patients ≥18 years old; histopathologically confirmed grade 1-2 midgut neuroendocrine tumor with documented progression during the year preceding inclusion upon RECIST criteria on computerized tomography, Octreoscan or Ga-68 positron emission tomography/computerized tomography
- Patients having an indication for Lu-177 Dotatate treatment validated during multidisciplinary meeting coordinated by Pr Rosine Guimbaud under RENATEN coordination;
- Measurable target lesions upon RECIST criteria
- Patients on somatostatin analogues treatment. Every somatostatin analogue injection should be organized to be administered 24 to 48 hours after each injection of Lu-177 Dotatate.
- All patients should be in a clinical state allowing them to continue treatment.
- Social security affiliation is mandatory.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.