177Lu-DOTATATE Modified Delivery Based on Individualized Dosimetry

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.

Timeline

Start

2024-05-03

Primary completion

2029-12-31

Completion

2029-12-31

Publications

• Background 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.
• Background Soulek 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.
• Background Capala 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.
• Background Sgouros 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.

Drugs

Indications