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RECRUITING
NCT06395402
PHASE2

177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry

Sponsor: University of Iowa

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-05-03

Completion Date

2029-12-31

Last Updated

2025-07-22

Healthy Volunteers

No

Interventions

DRUG

Lutetium 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