Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06395402

177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry for Neuroendocrine Tumors

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

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Iowa

Lead Sponsor

N

Novartis

Collaborating Sponsor

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 SPECT/CT scans and blood tests are performed to monitor the distribution and effects of the treatment. During the study, participants will undergo PET/CT 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

Eligible

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.
Not Eligible

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.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 32 weeks (4 cycles every 8 weeks)

Participants receive up to 4 cycles of Lutetium Lu 177 dotatate therapy, administered intravenously once every 8 weeks. The first cycle dose is 200 millicuries. Subsequent doses are either standardized at 200 millicuries or customized up to 400 millicuries based on individual dosimetry to optimize safety and effectiveness. Participants in the customized dose group undergo specialized imaging and blood sampling to monitor radiopharmaceutical distribution and clearance.

4 treatment visits every 8 weeks; imaging on treatment days 1 and 3-4 after first cycle and days 1 and 3-4 after cycles 2 and 3 for the customized dose group

Follow-up

Duration - Up to lifelong follow-up after treatment completion

Participants return to the treatment site at 2, 3, 6, and 12 months after the last treatment cycle for monitoring of side effects, treatment outcomes, and CT scans at 6 months. Participants also have lifelong follow-up to monitor for late radiation side effects.

Visits at 2, 3, 6, and 12 months post-treatment plus lifelong contact

Trial Site Locations

Total: 1 location

1

Holden Comprehensive Cancer Center at the University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

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Research Team

S

Stephen A Graves, Ph.D., DABR

Y

Yusuf Menda, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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