Customized Lutetium-177 treatment for neuroendocrine tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine if personalized dosimetry for Lutetium-177 DOTATATE improves treatment outcomes in adults with unresectable neuroendocrine tumors. Participants will undergo SSTR PET imaging and be randomized to receive either standard treatment or a customized dose based on individual tumor and kidney uptake. The study includes blood tests and patient-reported outcomes to assess the effectiveness and safety of the treatment. Follow-up visits will occur approximately every eight weeks to monitor progress.

Why it matters

Who can join: the full rules

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.

Inclusion 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.

Exclusion Criteria:

* 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™.

Where it's running

• Holden Comprehensive Cancer Center at the University of Iowa
  Iowa City, Iowa, United States Recruiting

Study contacts

• Principal investigator: Stephen Graves, Ph.D., DABR — University of Iowa
• Study coordinator: Stephen A Graves, Ph.D., DABR
• Email: stephen-a-graves@uiowa.edu
• Phone: +1 319 356 3656

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Investigating the impact of somatostatin analogues on tumor dose during radionuclide therapy

  This study is testing if stopping or continuing long-acting somatostatin treatment affects how well radionuclide therapy works for adults with neuroendocrine tumors.

  Recruiting Phase 2/3 The Netherlands Cancer Institute · Amsterdam · NCT06855095

• Comparing two doses of Everolimus for treating neuroendocrine tumors

  This study is testing whether a lower dose of Everolimus can effectively treat patients with advanced neuroendocrine tumors while causing fewer side effects compared to a higher dose.

  Recruiting at 2 sites Phase 2 AC Camargo Cancer Center · São Paulo, São Paulo and 1 other locations · NCT06472388

• Exploring new biomarkers for diagnosing and treating neuroendocrine tumors

  This study is testing new ways to diagnose and treat neuroendocrine tumors by looking at blood samples to see if they can provide better information about the cancer.

  Recruiting University of Roma La Sapienza · Rome, Italy · NCT04464122

• Combination therapy for Grade 2 liver-dominant neuroendocrine tumors

  This study is testing a new combination treatment of two drugs followed by a special radiation therapy to see if it helps people with Grade 2 liver-dominant neuroendocrine tumors live longer without their cancer getting worse.

  Recruiting Phase 2 Abramson Cancer Center at Penn Medicine · La Jolla, California and 4 other locations · NCT04339036

• New DLL3 PET/CT imaging for neuroendocrine tumors compared with standard scans

  A new PET/CT scan using the 68Ga-DLL3 nanobody is being tested to see if it detects metastatic neuroendocrine tumors better than current scans in adults.

  Recruiting at 2 sites Phase 2 Peking University First Hospital · Beijing, Beijing Municipality and 1 other locations · NCT07733024

• CTX-471 for NCAM-positive metastatic neuroendocrine tumors

  A phase 2 trial is testing CTX-471 in adults with NCAM (CD56) positive metastatic neuroendocrine tumors that have progressed after standard therapy.

  Recruiting at 2 sites Phase 2 Compass Therapeutics · St Louis, Missouri and 1 other locations · NCT07684170

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.