Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06395402

177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry

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

120

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

Sponsors

U

University of Iowa

Lead Sponsor

N

Novartis

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this study is to learn if individualized dosimetry-based prescribing of Lutetium-177 DOTATATE (Lutathera, Novartis Pharmaceuticals) improves treatment outcomes for adults with unresectable neuroendocrine tumors. To investigate this, study participants will: * Undergo Somatostatin Receptor (SSTR) positron emission tomography (PET) imaging, such as a DOTATOC PET/CT scan * Be randomized to receive standard treatment (as per FDA guidelines) or investigational treatment (customized dosing of Lutathera based upon dosimetry) * Undergo blood tests for 4 to 8 weeks after each Lutathera treatment * Complete patient reported outcome questionnaires * Visit the clinic for follow-up about every 8 weeks.

CONDITIONS

Official Title

177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

In order to be eligible to participate in this study, an individual must meet all of the following criteria. A physical, with vital signs, concomitant medication review, and medical history must be completed within 60 calendar days to confirm appropriateness of Lutathera treatment as well as to foundation for listed criteria.

  • 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.
Not Eligible

You will not qualify if you...

  • 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™.

AI-Screening

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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

CONTACT

Y

Yusuf Menda, MD

CONTACT

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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177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry | DecenTrialz