Your session is about to expire
← Back to Search
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
Have received Lu-DOTA-TATE treatment at the London Health Sciences Centre under the Special Access Programed or other radionuclide therapy for neuroendocrine tumor.
Presence of somatostatin receptor positive tumour(s) with at least 1 tumour site reliably evaluable by CT or MRI of at least 1.5 cm with respect to RECIST criteria.
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 belowSelect...
I have received Lu-DOTA-TATE treatment for my neuroendocrine tumor.
Select...
My tumor shows positive for somatostatin receptors and can be measured by CT or MRI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 years (end of study)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years (end of study)
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
661 Previous Clinical Trials
413,856 Total Patients Enrolled
david laidley, MDPrincipal InvestigatorLondon Health Sciences Centre & Lawson Health Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood sugar levels are not under control and are much higher than normal.I haven't had major cancer treatments or changed my Sandostatin LAR dose in the last 12 weeks.My kidney function tests are within the required range.I meet all the required criteria for secondary therapy in the study.My cancer shows positive for somatostatin receptors, confirmed by a recent scan.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.I am not eligible for Group B if I meet certain criteria.I meet all the required criteria for the primary therapy group in the study.I do not have any untreated serious health or mental conditions that could affect my participation.I am not part of Group A or do not meet their exclusion criteria.I can perform daily activities with minimal assistance.I have had radiation therapy to over 25% of my bone marrow.My cancer growth rate is low or stable after chemotherapy.I have received Lu-DOTA-TATE treatment for my neuroendocrine tumor.I am a candidate for surgery aimed at curing my condition, but I may have had surgery for symptom relief without affecting the target lesion.My tumor shows positive for somatostatin receptors and can be measured by CT or MRI.Your blood levels need to be within a certain range: hemoglobin should be at least 90 g/L, white blood cell count should be at least 3 x 109/L, and platelets should be at least 100 x 109/L, all measured within 2 weeks before joining the study.Your liver function tests need to be within a certain range, not more than three times the normal limit.My brain metastases have been stable or treated for at least 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Primary Therapy with Lu-DOTA-TATE
- Group 2: Secondary Therapy with Lu-DOTA-TATE
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.
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
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger