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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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

Lutetium-177 Octreotate (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02743741 — N/A
Neuroendocrine Tumors Research Study Groups: Lutetium-177 Octreotate
Neuroendocrine Tumors Clinical Trial 2023: Lutetium-177 Octreotate Highlights & Side Effects. Trial Name: NCT02743741 — N/A
Lutetium-177 Octreotate (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02743741 — N/A
~30 spots leftby Jun 2026