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Lu-DOTA-TATE for Neuroendocrine Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.I do not have any untreated serious health or mental conditions that could affect my participation.My kidney function tests are within the required range.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 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.
- Group 1: Primary Therapy with Lu-DOTA-TATE
- Group 2: Secondary Therapy with Lu-DOTA-TATE
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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