RECRUITING

177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry

Conditions

Neuroendocrine Tumors Neuroendocrine Tumor Grade 1 Neuroendocrine Tumor Grade 2 lutetium Lu 177 dotatate Radiotherapy Planning, Computer-Assisted

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry

Quick Facts

Study Start:2024-05-03

Study Completion:2029-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06395402

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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™.

Inclusion Criteria

Exclusion 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.

* 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™.

Contacts and Locations

Study Contact

Stephen A Graves, Ph.D., DABR

CONTACT

+1 319 356 3656

stephen-a-graves@uiowa.edu

Yusuf Menda, MD

CONTACT

+1 319 356 3656

yusuf-menda@uiowa.edu

Principal Investigator

Stephen Graves, Ph.D., DABR

PRINCIPAL_INVESTIGATOR

University of Iowa

Study Locations (Sites)

Holden Comprehensive Cancer Center at the University of Iowa

Iowa City, Iowa, 52242

United States

Collaborators and Investigators

Sponsor: University of Iowa

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-03

Study Completion Date2029-12-31

Study Record Updates

Study Start Date2024-05-03

Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

lutetium Lu 177 dotatate
Radiotherapy Planning, Computer-Assisted

Additional Relevant MeSH Terms

Neuroendocrine Tumors
Neuroendocrine Tumor Grade 1
Neuroendocrine Tumor Grade 2