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Radioisotope Therapy
Lu-DOTATATE for Neuroendocrine Cancer
N/A
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate liver function tests within 2 weeks prior to enrollment: total bilirubin ≤ 5 x ULN, ALT ≤ 5 x ULN, AST ≤ 5 x ULN, alkaline phosphatase ≤ 5 x ULN
Age ≥ 18 years
Must not have
Candidate for curative and/or debulking surgical resections
Radiotherapy to more than 25% of the bone marrow
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
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.
Who is the study for?
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.
What is being tested?
The study tests Lutetium-177 Octreotate's effectiveness in patients with neuroendocrine tumors who are Somatostatin receptor-positive. It involves four treatment cycles with possible dose adjustments based on individual responses and will compare progression-free survival at one year.
What are the potential side effects?
Potential side effects may include nausea, fatigue, kidney damage, blood cell count changes leading to increased infection risk or bleeding problems. Close monitoring of hematological reserve is required especially in patients with extensive bone metastases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My recent liver tests are within the normal range.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My tumor is confirmed to be neuroendocrine through a biopsy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am eligible for surgery to remove or reduce my cancer.
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I have received radiation therapy to a large portion of my bone marrow.
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I have another cancer that has worsened in the past 3 years.
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My diabetes is not under control.
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I have had treatment with radioactive drugs before.
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I do not have health issues like urinary incontinence that could affect my treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Lutetium-177 OctreotateExperimental Treatment1 Intervention
Lutetium-177 Octreotate 200 mCi (7.4 GBq) by IV for 18-30 weeks
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Lutetium-177 Octreotate (177Lu-DOTATATE) is a targeted radiation therapy that binds to somatostatin receptors, which are frequently overexpressed on Neuroendocrine Tumor (NET) cells. This binding allows for the direct delivery of radiation to the tumor cells, thereby minimizing damage to surrounding healthy tissues.
This targeted approach is significant for NET patients as it offers a more precise treatment option with potentially fewer side effects compared to traditional chemotherapy, and it can improve progression-free survival and quality of life for those with somatostatin receptor-positive NETs.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,519 Previous Clinical Trials
502,977 Total Patients Enrolled
5 Trials studying Neuroendocrine Tumors
2,491 Patients Enrolled for Neuroendocrine Tumors
Ozmosis Research Inc.Industry Sponsor
23 Previous Clinical Trials
4,931 Total Patients Enrolled
Canadian Molecular Imaging Probe ConsortiumUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am eligible for a potentially curative surgery or targeted liver therapy.My case has been reviewed by a tumor board for clinical trial suitability.I am eligible for surgery to remove or reduce my cancer.I haven't had radiation on the cancer we're targeting in the last 3 months.I am willing and able to follow the study's schedule and procedures.I have received radiation therapy to a large portion of my bone marrow.My brain metastases have been stable for 6 months or more after treatment.I have another cancer that has worsened in the past 3 years.I haven't had certain cancer treatments in the last 4 weeks.My scans show my cancer has grown in the last 6 months.My recent liver tests are within the normal range.My cancer has spread to my bones significantly, but I am under close blood monitoring.My diabetes is not under control.I am 18 years old or older.I have had treatment with radioactive drugs before.I do not have health issues like urinary incontinence that could affect my treatment.I can take care of myself but might not be able to do heavy physical work.My tumor is confirmed to be neuroendocrine through a biopsy.I am not pregnant or breastfeeding and agree to use birth control during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Lutetium-177 Octreotate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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