Clinical Trial

177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry

Study acronym: LUMOD-ID
Recruiting Phase 2
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-04-29; most recent amendment 2025-07-17.
Status change: Not Yet Recruiting → Recruiting 2024-06-21
Trial Details
NCT Number NCT06395402
Lead Sponsor University of Iowa
Collaborators: Novartis
Conditions Neuroendocrine Tumors, Neuroendocrine Tumor Grade 1, Neuroendocrine Tumor Grade 2
Enrollment 120 participants
Start Date 2024-05-03
Primary Completion 2029-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-22