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Individualized Lutathera Dosing for Neuroendocrine Tumors

This study is looking at whether customizing the dose of Lutetium Lu 177 dotatate therapy (Lutathera), an FDA-approved treatment for certain neuroendocrine tumors, can improve results. Lutathera works by targeting specific receptors (somatostatin receptors) on tumor cells and delivering radiation directly to them. You could be eligible if you are an adult (18 years or older) with an unresectable neuroendocrine tumor, specifically Grade 1 or Grade 2. The main goal is to see how many people have their tumors shrink or disappear (Objective Response Rate) six months after finishing treatment. The current recruitment status is unclear.

Study design
This is a randomized controlled study planning to enroll 120 participants. You have a 2 out of 3 chance of receiving the customized Lutathera dose.
What's involved
You will have a PET scan, receive Lutathera treatment, have blood tests for 4-8 weeks after each treatment, complete questionnaires, and visit the clinic about every 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be measured 6 months after you complete treatment.

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NCT06395402

177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Iowa
~120 participants
Updated 2025-07-22 on ClinicalTrials.gov
What's tested:Lutetium Lu 177 dotatate therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR) at 6 months after treatment
Measured over 6 months after completion of treatment

Conditions

Neuroendocrine Tumors
Neuroendocrine Tumor Grade 1
Neuroendocrine Tumor Grade 2

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Where it's being run

1 sites across 1 states
Iowa1

Study leadership

  • Stephen Graves, Ph.D., DABR · PRINCIPAL_INVESTIGATOR · University of Iowa

Who to contact

Stephen A Graves, Ph.D., DABR
[email protected]
+1 319 356 3656
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Aged ≥ 18 years at time of consent.
Pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be a well-differentiated neuroendocrine tumor (Ki-67 ≤ 20%) with the primary tumor location known or believed to be gastroenteropancreatic origin (GEP-NET)
Disease measuring ≥ 1.5 cm in diameter on CT or MRI as measured per RECIST that shows uptake \> liver background on sstr2 PET/CT with any FDA approved sstr2 imaging agent. SSTR2 PET/CT must have been obtained within 90 days prior to scheduled C1D1 of Lutathera.
Recommended to receive LUTATHERA® therapy for unresectable and/or metastatic neuroendocrine disease.
Adequate performance status (ECOG of 0 or 1; or Karnofsky performance status of ≥70).
Agrees to contraception during therapy.
Neutrophil count within normal limits within 28 days of treatment day 1.
Platelet count within normal limits within 28 days of treatment day 1.
Ability to take oral medication and be willing to adhere to the treatment regimen
For individuals of reproductive potential: agreement to use effective birth control
Agreement to adhere to Lifestyle Considerations throughout study duration: abstain from caffeine or xanthine-containing products as well as alcohol before the start of cycle dosing and through the cycle's final blood sample; minimize social interactions during low blood counts.

Exclusion

Individuals who are pregnant or lactating (note: potential participants should not engage in 'pump \& dump' strategy; lactation must be discontinued).
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring inpatient admission or a delay to start of therapy), fever, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Surgery, radiation therapy, or chemotherapy ≤ 4 weeks of C1D1 (Toxicities from prior therapies should have resolved to ≤ CTCAE grade 1 or a new baseline established).
Prior peptide-receptor radiotherapy (PRRT).
Therapeutic investigational drug within 4 weeks of C1D1 (imaging agents are acceptable).
A concurrent malignancy that, in the opinion of the investigator, would cause a safety risk by delaying therapy or confound/negatively impact study objectives (documentation of the rationale must be provided)
Prior external beam radiation dose to the kidneys of \>10 Gy (mean dose to functional renal volume).
Prior external beam radiation (including brachytherapy) involving 25% of the bone marrow (excluding scatter doses of ≤ 5 Gy) as estimated by a radiation oncologist.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Octreoscan® or Netspot™.

What this trial measures

  • Objective Response Rate (ORR) at 6 months after treatment6 months after completion of treatment

    Determine objective response rate in patients with grade 1 or 2 gastroenteropancreatic neuroendocrine tumors (GEP-NET) treated with dosimetrically-determined LUTATHERA administration compared to active control.