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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will evaluate the efficacy and safety of Lutetium-177 Octreotate, a treatment for neuroendocrine tumors, in 195 patients. Eligible patients will undergo a diagnostic Ga 68 PET scan, and those who show somatostatin will receive 4 cycles of Lu-DOTATATE treatment. Dose adjustment will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated for progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive treatment but will be followed until progression and acts as control

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The proportion of patients progression-free using RECIST 1.1 criteria

Secondary outcome measures

Overall survival

The Quality of Life (QoL) in patients treated with Lu-DOTATATE (177Lu)

The acute and late adverse effects of Lu-DOTATATE (177Lu) using CTCAE Version 4.03

+2 more

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,468 Previous Clinical Trials

484,324 Total Patients Enrolled

5 Trials studying Neuroendocrine Tumors

2,491 Patients Enrolled for Neuroendocrine Tumors

Ozmosis Research Inc.Industry Sponsor

19 Previous Clinical Trials

4,770 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open spots for participating in this experiment?

"This clinical trial is not admitting patients at this time. Initially posted on July 15th 2016, and most recently updated April 7th 2022, it has been concluded for the moment. If you are seeking other opportunities to participate in medical trials, there are 166 active studies involving neuroendocrine tumors and 42 open studies using Lutetium-177 Octreotate currently recruiting participants."

Answered by AI

How many individuals have been enrolled in this clinical trial?

"Unfortunately, the deadline for this study has already passed. Initially posted on July 15th 2016 and last edited April 7th 2022, no further candidates are being accepted. If you're seeking other trials in a similar vein, 166 experiments are currently recruiting patients with neuroendocrine tumors as well as 42 studies using Lutetium-177 Octreotate treatments."

Answered by AI

Could you elaborate on what other experiments have been done using Lutetium-177 Octreotate?

"Currently, 42 trials are actively researching the efficacy of Lutetium-177 Octreotate and 3 of those studies have reached Phase 3. Across 279 research centres spread out throughout Gothenburg and Iowa, scientists continue to investigate this promising treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors

2016. "Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02743741.

All > Neuroendocrine Tumor