177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry
LUMOD-ID
1 other identifier
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2024
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2024
CompletedFirst Posted
Study publicly available on registry
May 2, 2024
CompletedStudy Start
First participant enrolled
May 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
July 22, 2025
July 1, 2025
5.7 years
April 25, 2024
July 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) at 6 months after 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.
6 months after completion of treatment
Secondary Outcomes (3)
Treatment emergent toxicity assessment
From treatment day 1 every 6 months for 5 years post-treatment
Time to disease progression
Up to 5 years post-treatment
Correlation of hematologic toxicities
At 6 months post-treatment
Study Arms (2)
Dosimetry-based lutetium Lu 177 dotatate therapy
EXPERIMENTALIntravenous administration of lutetium Lu 177 dotatate once every 8 weeks for up to 4 total cycles. Intended administered radioactivity: Cycle 1: 200 millicuries (mCi) Cycles 2, 3, and 4: based upon dosimetry for radiation exposure to bone marrow (no more than 1 Gy per administration) and kidneys (maximum dose 28 Gy total). Not to exceed 400 millicuries (mCi) per cycle (1400 mCi maximum for all cycles).
Standard lutetium Lu 177 dotatate
ACTIVE COMPARATORIntravenous administration of lutetium Lu 177 dotatate once every 8 weeks for up to 4 total cycles. Each cycle is intended to receive 200 millicuries of radioactivity for a total treatment of 800 millicuries.
Interventions
LUTATHERA is an FDA approved radiopharmaceutical therapy for gastroenteropancreatic neuroendocrine tumor (GEP-NET). This radiopharmaceutical binds to somatostatin receptors, which are overexpressed on GEP-NET cells, and subsequently delivers beta particle radiation to the tumor cells.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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™.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Iowalead
- Novartiscollaborator
Study Sites (1)
Holden Comprehensive Cancer Center at the University of Iowa
Iowa City, Iowa, 52242, United States
Related Publications (4)
Park EA, Graves SA, Menda Y. The Impact of Radiopharmaceutical Therapy on Renal Function. Semin Nucl Med. 2022 Jul;52(4):467-474. doi: 10.1053/j.semnuclmed.2022.02.004. Epub 2022 Mar 18.
PMID: 35314056BACKGROUNDSoulek DK, Mastascusa NJ, Martin ME, Graves SA. Practical Considerations for Implementation of 177Lu-DOTATATE Neuroendocrine Tumor Treatment Programs. J Nucl Med Technol. 2022 Sep 1;50(3):195-202. doi: 10.2967/jnmt.122.263813. Epub 2022 Jun 14.
PMID: 35701215BACKGROUNDCapala J, Graves SA, Scott A, Sgouros G, James SS, Zanzonico P, Zimmerman BE. Dosimetry for Radiopharmaceutical Therapy: Current Practices and Commercial Resources. J Nucl Med. 2021 Dec;62(Suppl 3):3S-11S. doi: 10.2967/jnumed.121.262749.
PMID: 34857621BACKGROUNDSgouros G, Dewaraja YK, Escorcia F, Graves SA, Hope TA, Iravani A, Pandit-Taskar N, Saboury B, James SS, Zanzonico PB. Tumor Response to Radiopharmaceutical Therapies: The Knowns and the Unknowns. J Nucl Med. 2021 Dec;62(Suppl 3):12S-22S. doi: 10.2967/jnumed.121.262750.
PMID: 34857617BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Graves, Ph.D., DABR
University of Iowa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 25, 2024
First Posted
May 2, 2024
Study Start
May 3, 2024
Primary Completion (Estimated)
December 31, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
July 22, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Upon study completion
- Access Criteria
- Data are available upon a fully executed data usage authorization (DUA) between the University of Iowa and the recipient organization. Once the DUA is executed, the data will be transferred to the recipient in a HIPAA approved method. Data will be available, at minimum, for 7 years after the completion of the grant, consistent with privacy regulations.
Data will only be shared if the trial participant has consented to sharing. Trial data to share: imaging (CT, PET, MRI), dosimetry plans, participant demographics (race, ethnicity, age at consent), disease stage, organ contours for dosimetry, lutathera prescription, treatment history, concomitant medications, and dose modification and holds. Protocol, blank case report forms, and statistical analysis plan will be retained and shared. Imaging data are shared DICOM format. Adverse events will be categorized utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.