Lu-DOTATATE for Neuroendocrine Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a targeted radiation therapy called Lutetium-177 Octreotate in patients with advanced neuroendocrine tumors that have specific receptors. The treatment aims to deliver radiation directly to the cancer cells to stop their growth. Patients will receive multiple treatment cycles, and their progress will be monitored over time. Lutetium-177 Octreotate was approved by the FDA in January 2018 for treating certain types of neuroendocrine tumors.
Do I need to stop taking my current medications to join the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have had systemic, biologic, or other radioisotope therapies within 4 weeks prior to the first dose, you may not be eligible. It's best to discuss your current medications with the trial team.
Is Lu-DOTATATE generally safe for humans?
Lu-DOTATATE has been used as a treatment for neuroendocrine tumors and is generally considered safe, but it can have side effects. Some studies have shown that it is well-tolerated, but there can be issues like unwanted radiation exposure to bones if not properly managed. Adding certain substances can help reduce these risks.12345
What makes the drug Lu-DOTATATE unique for treating neuroendocrine cancer?
Lu-DOTATATE is unique because it uses a radioactive component to target and bind to specific receptors on neuroendocrine tumor cells, delivering radiation directly to the cancer cells while minimizing damage to surrounding healthy tissue. This targeted approach can lead to significant tumor regression and improved quality of life with fewer side effects compared to other treatments.13467
What data supports the effectiveness of the treatment Lutetium-177 DOTATATE for neuroendocrine cancer?
Research shows that Lutetium-177 DOTATATE is effective for treating neuroendocrine tumors, as it has been used successfully in patients with these types of tumors, including those with metastasized or inoperable conditions. Studies have demonstrated its early efficacy and manageable toxicity in patients with progressive metastatic neuroendocrine tumors.12368
Are You a Good Fit for This Trial?
This trial is for adults over 18 with biopsy-proven neuroendocrine tumors, showing progression and positive for Somatostatin receptors. They should have an ECOG performance status ≤ 2, adequate organ function, no prior radionuclide therapy or certain other treatments within the last few weeks, and not be pregnant or breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo 4 cycles of Lu-DOTATATE treatment with dose adjustments based on individualized dosimetry
Follow-up
Participants are monitored for progression-free survival at 12 months from the last dose
What Are the Treatments Tested in This Trial?
Interventions
- Lutetium-177 Octreotate
Lutetium-177 Octreotate is already approved in European Union, United States, Canada for the following indications:
- Unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults
- Somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults
- Gastroenteropancreatic NETs
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Ozmosis Research Inc.
Industry Sponsor
Canadian Molecular Imaging Probe Consortium
Collaborator
Cancer Care Ontario
Collaborator