What is Lutetium-177 DOTATATE studying for neuroendocrine tumors?

Lutetium-177 DOTATATE is being studied to see if personalized dosing based on individual radiation measurements improves treatment outcomes for adults with unresectable neuroendocrine tumors. The research compares standard fixed dosing to a customized approach to better target tumors while monitoring safety. This study is sponsored by the University of Iowa.

Who may be eligible for this neuroendocrine tumor clinical trial?

Adults aged 18 or older with confirmed well-differentiated neuroendocrine tumors of gastroenteropancreatic origin may be eligible. Participants must be able to follow study procedures and not be pregnant or breastfeeding. Please review eligibility criteria for more details.

Is there any cost to participate in this neuroendocrine tumor clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel or other expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06395402

Study of Lutetium-177 DOTATATE Dosage Based on Individualized Imaging for Treating Adults with Neuroendocrine Tumors

Led by University of Iowa · Updated on 2025-07-22

120

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying whether adjusting the dose of Lutetium-177 DOTATATE Lutathera based on individual dosimetry improves treatment results for adults with unresectable neuroendocrine tumors. This randomized controlled trial compares the standard fixed dose with a customized dosing approach guided by tumor and organ uptake, aiming to evaluate if personalized treatment can enhance outcomes. The study is sponsored by the University of Iowa and involves patients with well-differentiated gastroenteropancreatic neuroendocrine tumors. Participants will receive Lutathera through an intravenous infusion every 8 weeks for up to four cycles. The first dose is fixed at 200 millicuries for all participants. Those in the investigational group may receive higher doses up to 400 millicuries in subsequent cycles based on dosimetry imaging that tracks radiation exposure to tumors, kidneys, and bone marrow. The standard group continues with 200 millicuries per cycle. Imaging such as SPECTCT scans and blood tests are performed to monitor the distribution and effects of the treatment. During the study, participants will undergo PETCT scans before treatment, blood tests for several weeks after each Lutathera dose, and complete questionnaires about their health and symptoms. Follow-up visits occur about every 8 weeks during treatment and at 2, 3, 6, and 12 months after the last cycle. Long-term monitoring continues to assess side effects and treatment outcomes, including CT scans at 6 months and lifelong follow-up for radiation-related effects. The main outcome measure is the tumor response rate 6 months after treatment.

CONDITIONS

Brief Title

177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Signed and dated informed consent form.
Willingness to comply with all study procedures and availability for the study duration.
Age 18 years or older at consent.
Confirmed well-differentiated neuroendocrine tumor (Ki-67 ≤ 20%) with primary tumor believed to be gastroenteropancreatic.
Tumor measuring at least 1.5 cm on CT or MRI and showing uptake above liver background on somatostatin receptor PET/CT within 90 days prior to treatment.
Recommended for Lutathera therapy for unresectable and/or metastatic neuroendocrine disease.
Adequate performance status (ECOG 0 or 1; or Karnofsky ≥ 70).
Agreement to use contraception during therapy.
Normal neutrophil and platelet counts within 28 days before treatment.
Ability to take oral medication and willingness to follow treatment regimen.
Agreement to abstain from caffeine, xanthine products, and alcohol before and during treatment cycles, and to minimize social interactions during low blood counts.

You will not qualify if you...

Pregnancy or lactation (no breastfeeding during study).
Uncontrolled illnesses such as active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance.
Surgery, radiation, or chemotherapy within 4 weeks before treatment.
Prior peptide-receptor radiotherapy.
Use of investigational drugs within 4 weeks before treatment (except imaging agents).
Concurrent malignancy posing safety risk or confounding study objectives.
Prior external beam radiation to kidneys exceeding 10 Gy.
Prior external beam radiation involving more than 25% of bone marrow (excluding low scatter doses).
Known allergies to compounds similar to Octreoscan or Netspot agents.

Research Team

Stephen A Graves, Ph.D., DABR

Yusuf Menda, MD

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