Study Comparing Lutetium 177Lu-Edotreotide with Standard Care for Aggressive Grade 2 and 3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs)
Sponsor: ITM Solucin GmbH
ClinicalTrials ID:NCT04919226
This clinical trial is testing a new treatment called Lutetium 177Lu-Edotreotide against the best standard care for patients with aggressive grade 2 and 3 neuroendocrine tumors in the stomach, intestines, or pancreas. The study aims to evaluate the effectiveness, safety, and patient experiences of this new treatment.
Patient Parameters
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Program Overview
The study is designed to compare the effectiveness and safety of a new treatment called peptide receptor radionuclide therapy (PRRT) using 177Lu-Edotreotide with the best standard care available. This treatment is for patients with aggressive grade 2 and grade 3 neuroendocrine tumors that are well-differentiated and have somatostatin receptors. These tumors originate in the stomach, intestines, or pancreas. The study will also look at how patients feel about their treatment and any side effects they experience.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) that cannot be surgically removed.
- Have at least one measurable tumor as determined by specific imaging tests like CT or MRI.
- Tumors must be positive for somatostatin receptors (SSTR+).
Exclusion Criteria
- Allergic reactions to Lutetium 177Lu, edotreotide, DOTA, or similar substances.
- Previous treatment with Peptide Receptor Radionuclide Therapy (PRRT).
- Major surgery within the last 4 weeks before joining the trial.
- Participation in another clinical trial or use of an investigational drug or device within the last 30 days or longer, depending on the drug's half-life.
- Other active cancers.
- Serious non-cancerous diseases.
- Problems with kidney, liver, heart, or blood that could affect the safety of the trial treatments.
- Pregnant or breastfeeding women.
- Individuals unable to provide informed consent or considered vulnerable.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Stanford Cancer Center | 94305 | Palo Alto | California |
| University of Colorado Hospital, Nuclear Medicine | 80045 | Aurora | Colorado |
| H. Lee Moffitt Cancer Center & Research Institute | 33612 | Tampa | Florida |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Mayo Clinic - Rochester, Department of Oncology | 55905 | Rochester | Minnesota |
| Washington University Alvin J. Siteman Cancer Center | 63110 | Saint Louis | Missouri |
| Memorial Sloan-Kettering Cancer Center | 10065 | New York | New York |
| ICAHN School of Medicine at Mount Sinai, Tish Cancer Institute | 10128 | New York | New York |
| Duke University School of Medicine, Duke Cancer Institute | 27710 | Durham | North Carolina |
| Oregon Health and Science University | 97239-3098 | Portland | Oregon |
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