Study on Personalized Dosing of 177Lu-DOTATATE for Treating Neuroendocrine Tumors

Sponsor: University of Iowa

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06395402

Provider View

This clinical trial is exploring whether adjusting the dose of the treatment Lutetium-177 DOTATATE based on individual needs can improve outcomes for adults with neuroendocrine tumors that cannot be surgically removed.

Patient Parameters

Program Overview

The aim of this study is to see if personalizing the dose of Lutetium-177 DOTATATE (Lutathera) based on each patient's specific needs can lead to better treatment results for adults with neuroendocrine tumors that cannot be removed by surgery. Participants will undergo special imaging tests, be randomly assigned to receive either the standard treatment or a customized dose, and have regular blood tests and follow-up visits to monitor their health and the treatment's effects.

Description

This study is testing whether adjusting the dose of Lutetium-177 DOTATATE (Lutathera) based on individual needs can improve treatment for neuroendocrine tumors. Participants will be randomly assigned to receive either the standard dose or a customized dose based on how their body absorbs the treatment. The standard dose is 200 millicuries (mCi) per treatment, while the customized dose can go up to 400 mCi for some treatments.

Participants will have special imaging tests to see how the treatment is distributed in their body, especially in tumors and kidneys. These tests are done after the first treatment and then less frequently after subsequent treatments. Blood samples will also be collected to measure radioactivity levels.

All participants will be closely monitored for side effects and treatment outcomes, with follow-up visits at 2, 3, 6, and 12 months after the last treatment. A CT scan will be done 6 months after treatment to check the cancer's status. Long-term follow-up is important as radiation side effects can take years to appear.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed consent to participate.
  • Willing to follow all study procedures and available for the study duration.
  • Aged 18 years or older.
  • Diagnosed with a well-differentiated neuroendocrine tumor that cannot be surgically removed.
  • Tumor must be at least 1.5 cm in size and show specific uptake on imaging tests.
  • Recommended for Lutathera treatment for neuroendocrine disease.
  • Good overall health and performance status.
  • Agree to use contraception during treatment.
  • Normal blood cell counts and organ function.
  • Able to take oral medication and follow the treatment plan.
  • Agree to lifestyle considerations, such as avoiding caffeine and alcohol during treatment cycles.

Exclusion Criteria

  • Pregnant or breastfeeding individuals.
  • Uncontrolled illnesses or conditions that could interfere with the study.
  • Recent surgery, radiation, or chemotherapy within 4 weeks of starting the study.
  • Previous treatment with similar radiotherapy.
  • Participation in another drug trial within 4 weeks of starting the study.
  • Other cancers that could affect the study's safety or results.
  • Previous high-dose radiation to the kidneys or significant bone marrow radiation.
  • Allergic reactions to similar treatments.

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