Customized Lutetium-177 treatment for neuroendocrine tumors
177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry
This study is testing if a personalized dose of Lutetium-177 can improve treatment results for adults with hard-to-treat neuroendocrine tumors compared to standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT06395402 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with well-differentiated neuroendocrine tumors that meet specific imaging and size criteria.
Not a fit: Patients with poorly differentiated tumors or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and tailored treatments for patients with neuroendocrine tumors.
How similar studies have performed: Other studies have shown promise with personalized dosing approaches in similar contexts, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Iowa City, Iowa
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.