NCT02754297Active, not recruitingPhase 2
Personalized PRRT of Neuroendocrine Tumors
Personalized Peptide Receptor Radionuclide Therapy of Neuroendocrine Tumors: A Phase 2 Study
Source: ClinicalTrials.gov · Last updated 21 Aug 2024
Brief summary (registry, in English)
In this study, peptide receptor radionuclide therapy (PRRT) with 177Lu-Octreotate (LuTate) will be personalized, i.e. administered activity of LuTate will be tailored for each patient to maximize absorbed radiation dose to tumor, while limiting that to healthy organs. The purpose of this study is to: * Assess the objective (radiological), symptomatic and biochemical response rates following an induction course of personalized PRRT; * Assess the overall, the disease-specific, and the progression-free survival following P-PRRT; * Correlate therapeutic response and survival with tumor absorbed radiation dose; * Evaluate the acute, subacute and chronic adverse events following P-PRRT; * Correlate toxicity (i.e. occurence and severity of adverse events) with absorbed radiation doses to organs at risk; * Optimize the quantitative SPECT imaging-based dosimetry methods in a subset of 20 patients (sub-study funded by the Canadian Institutes of Health Research). This study also has a compassionate purpose, which is to provide access to PRRT to patients.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 275 (actual)
- First submitted
- 10 Mar 2016
- Start date
- 12 Apr 2016
- Primary completion date
- 12 Apr 2025
- Lead sponsor
- CHU de Quebec-Universite Laval
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT02754297
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 275
- From 12 Apr 2016 to the primary completion date, 12 Apr 2025
- 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.
Other illness
- Very limited survival prognosis (i.e. less than a few weeks, because of the NET disease or any other condition) or Eastern Cooperative Oncology Group (ECOG) 4 performance status;
Other
- Pregnancy;
- Breastfeeding;.
- Inability to obtain informed consent of the participant.
Who the study is looking for
- Patient suffering from a progressive and/or symptomatic NET (any site);
- Patient ineligible to, or refusing a potentially curative treatment such as surgical resection;
- Patient who did not respond, is intolerant or refuses other indicated and available palliative treatments;
- Demonstration of overexpression of somatostatin receptor by tumor lesions by scintigraphic imaging (Octreoscan or 68Ga positron emission tomography.
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 Quebec-Universite Laval Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.