RecruitingPhase 2NCT06395402

177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry


Sponsor

University of Iowa

Enrollment

120 participants

Start Date

May 3, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Lutetium Lu 177 dotatate therapy for people with neuroendocrine tumor grade 1, neuroendocrine tumor grade 2, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLutetium Lu 177 dotatate therapy

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.


Locations(1)

Holden Comprehensive Cancer Center at the University of Iowa

Iowa City, Iowa, United States

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NCT06395402


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