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Radiopharmaceutical

Lu-DOTA-TATE for Neuroendocrine Cancer

Phase 2
Waitlist Available
Led By david laidley, MD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female ≥ 14 - 90 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
Presence of somatostatin receptors on (at least) the target lesion demonstrated by uptake of OctreoScan® at least equal to liver uptake within 12 weeks of enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years (end of study)
Awards & highlights

Study Summary

This trial will test whether Lutetium-177 octreotate can help control symptoms, stabilize disease, and improve quality of life for patients with a certain type of tumor. The study will also measure the safety and overall survival of patients treated with Lutetium-177 octreotate.

Who is the study for?
This trial is for individuals aged 14-90 with somatostatin receptor positive tumors, who have a life expectancy of more than 26 weeks and good organ function. They must not be pregnant or breastfeeding, have uncontrolled diabetes, brain metastases unless stable for 6+ months, or had certain treatments within the last 12 weeks.Check my eligibility
What is being tested?
The study tests Lu-DOTA-TATE's effectiveness in patients with neuroendocrine carcinoma by observing how long they live without disease progression and overall survival. It also evaluates safety and quality of life impacts.See study design
What are the potential side effects?
While specific side effects are not listed here, radiopharmaceuticals like Lu-DOTA-TATE can cause nausea, fatigue, pain at injection site and may affect blood counts leading to increased risk of infections or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 14 and 90 years old. If I am a woman who can have children, I have a negative pregnancy test outside my period's first 10 days.
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My cancer shows positive for somatostatin receptors, confirmed by a recent scan.
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I meet all the required criteria for secondary therapy in the study.
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I am between 14 and 90 years old. If I am a woman who can have children, I have a negative pregnancy test outside my period's first 10 days.
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My kidney function tests are within the required range.
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I meet all the required criteria for the primary therapy group in the study.
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I can perform daily activities with minimal assistance.
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My cancer growth rate is low or stable after chemotherapy.
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I have received Lu-DOTA-TATE treatment for my neuroendocrine tumor.
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My tumor shows positive for somatostatin receptors and can be measured by CT or MRI.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years (end of study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years (end of study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tumour response measured by RECIST criteria
Secondary outcome measures
Progression Free Survival
Quality of Life Response Changes

Trial Design

2Treatment groups
Experimental Treatment
Group I: Secondary Therapy with Lu-DOTA-TATEExperimental Treatment1 Intervention
Patients who have received previous treatment with Lu-DOTA-TATE (Lutetium-177 Octreotate) under the special access program are eligible to be treated in this study. Patients will receive Lu-DOTA-TATE by intravenous infusion.
Group II: Primary Therapy with Lu-DOTA-TATEExperimental Treatment1 Intervention
Lu-DOTA-TATE (Lutetium-177 Octreotate) will be administered by intravenous infusion to participants who have not been previously treated with Lu-DOTA-TATE

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
654 Previous Clinical Trials
413,119 Total Patients Enrolled
david laidley, MDPrincipal InvestigatorLondon Health Sciences Centre & Lawson Health Research Institute

Media Library

Lu-DOTA-TATE (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT02236910 — Phase 2
Neuroendocrine Carcinoma Research Study Groups: Primary Therapy with Lu-DOTA-TATE, Secondary Therapy with Lu-DOTA-TATE
Neuroendocrine Carcinoma Clinical Trial 2023: Lu-DOTA-TATE Highlights & Side Effects. Trial Name: NCT02236910 — Phase 2
Lu-DOTA-TATE (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02236910 — Phase 2

Frequently Asked Questions

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

Will seniors be included in the trial's participant recruitment?

"This experiment calls for the enrolment of individuals between their teens and nonagenarian stage. There are special trials dedicated to those below 18 years old (8 in total) as well as 85 studies concentrated on senior citizens."

Answered by AI

What adverse effects have been reported from the use of Lu-DOTA-TATE?

"Lu-DOTA-TATE is currently classified as a '2' on the safety scale due to limited available data confirming its efficacy, but supportive evidence of its safety."

Answered by AI

Are there any vacancies available for enrollment in this clinical trial?

"The information found on clinicaltrials.gov reveals that this research is not currently open to new subjects, despite being initially posted in July 2014 and last updated in April 2022. Fortunately, there are 86 other medical studies accepting applications at the present moment."

Answered by AI

Am I a suitable contender for this trial?

"The enrollment criteria for this medical experiment requires that patients possess neuroendocrine carcinomas and be between 14 to 90 years of age. This trial is seeking 66 participants in total."

Answered by AI
Recent research and studies
~4 spots leftby Dec 2024