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Radioisotope Therapy

Lu-DOTA-TATE for Neuroendocrine Carcinoma

Phase 2
Recruiting
Led By Donald W Morrish, MD, PhD
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Group B (Maintenance Therapy): Serum creatinine ≤ 150 μmol/L, and a calculated or estimated GFR of ≥ 50 mL/min
Group B (Maintenance Therapy): Liver function tests ≤ 3X the limit of normal; Serum albumin ≥ 23 g/L
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 days after each lu-dota-tate treatment
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Study Summary

This trial is a prospective, single arm, open label study of Lu-DOTA-TATE in patients with well-differentiated, somatostatin receptor positive neuroendocrine tumours.

Who is the study for?
This trial is for individuals with neuroendocrine tumors, aged 14-90, who have a life expectancy of more than 12 weeks and are physically able to perform daily activities (ECOG ≤2). They must have somatostatin receptor positive tumors confirmed by imaging and meet specific blood test criteria. Those previously treated with Lu-DOTA-TATE or having certain medical conditions are excluded.Check my eligibility
What is being tested?
[177]Lu-DOTA-TATE therapy is being tested for its effectiveness in treating neuroendocrine tumors and its impact on patients' quality of life and survival. The study will also evaluate the safety of this treatment which has been used under special access but now requires clinical trial assessment.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, nausea, fatigue, bone marrow suppression leading to low blood cell counts, kidney damage, liver toxicity, hormonal imbalances and potentially others not listed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is good, with creatinine levels low and GFR above 50 mL/min.
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My liver is functioning well, and my blood protein levels are normal.
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I can take care of myself but might not be able to do heavy physical work.
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I am between 14 and 90 years old.
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I have given my written consent to participate.
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My kidney function is good, with creatinine ≤ 150 µmol/L and GFR ≥ 50 mL/min.
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I have a confirmed diagnosis of a neuroendocrine tumor.
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My doctor expects me to live more than 12 weeks.
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I can take care of myself and perform daily activities.
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My cancer is growing or has spread, as shown by imaging tests.
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I am between 14 and 90 years old.
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My tumor shows up more brightly than my liver on specific scans.
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I have previously received Lu-DOTA-TATE treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 days after each lu-dota-tate treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 days after each lu-dota-tate treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Body Weight Changes
Lu-177 scan disease evaluation
+1 more
Secondary outcome measures
Change in Quality of Life (EORTC QLQ)
Change in Quality of Life (ESAS-r)
Change in haematology
+5 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: [177]Lu-DOTA-TATE TherapyExperimental Treatment1 Intervention
Nominal, induction stage dose of 150 mCi (5.55 GBq) [177]Lu-DOTA-TATE every 10 - 14 weeks for 4 treatments. Nominal maintenance stage dose of 75 mCi (2.78 GBq) [177]Lu-DOTA-TATE every 22 - 40 weeks, up to a maximum of 8 treatments.

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
35,712 Total Patients Enrolled
Donald W Morrish, MD, PhDPrincipal InvestigatorProfessor of Endocrinology and Oncology, University of Alberta, Cross Cancer Institute
1 Previous Clinical Trials
250 Total Patients Enrolled

Media Library

Lutetium-177 Octreotate (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01876771 — Phase 2
Neuroendocrine Carcinoma Research Study Groups: [177]Lu-DOTA-TATE Therapy
Neuroendocrine Carcinoma Clinical Trial 2023: Lutetium-177 Octreotate Highlights & Side Effects. Trial Name: NCT01876771 — Phase 2
Lutetium-177 Octreotate (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01876771 — Phase 2

Frequently Asked Questions

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

Could you explain the participant requirements for this trial?

"The minimum age for enrollment in this clinical trial is 14 and the maximum age is 90."

Answered by AI

How many people are the researchers hoping to test in this clinical trial?

"That is correct, the clinical trial is still looking for 500 enrollees. The study was posted on 4/29/2014 and updated as recently as 4/12/2021 according to clinicaltrials.gov."

Answered by AI

Is [177]Lu-DOTA-TATE a safe medical treatment for patients?

"There is some clinical data supporting the safety of [177]Lu-DOTA-TATE, but none for efficacy. Our team has rated it a 2 on our scale."

Answered by AI

Which patients fit the screening criteria for this research?

"This specific clinical trial is looking for 500 patients that have carcinoma or neuroendocrine. The ages of the participants must be 14-90. In addition, they must meet the following requirements:"

Answered by AI

Are we still able to sign up for this experiment?

"The trial is still open and recruiting patients, according to the information available on clinicaltrials.gov. The study was first posted on 4/29/2014, with the most recent edit taking place on 4/12/2021."

Answered by AI

Are there similar procedures to [177]Lu-DOTA-TATE that have been trialed before?

"[177]Lu-DOTA-TATE is being trialed in 23 separate studies, one of which is in Phase 3. The global trial locations number 162, with the majority taking place in Cleveland, Ohio."

Answered by AI

What is the primary aim of this clinical trial?

"The purpose of this study, which will be evaluated over the course of several months and years, is to observe changes in tumour response in patients after treatment. Additionally, this trial aims to secondary outcomes like change in liver function and quality of life. To do so, blood samples will be taken at various intervals to monitor for toxicity levels and questionnaires will be administered to gauge quality of life. The safety and tolerability of the medication will also be monitored for any adverse events that may occur during or after treatment."

Answered by AI
~249 spots leftby Dec 2033