Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors

Summary

This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be followed until progression and acts as control group.

Timeline

Start

2016-07-15

Primary completion

2026-06

Completion

2026-06

Publications

• Macsuka MJ, Driscoll B, Yeung IWT, Publicover J, Metser U, Juergens R, Myrehaug SD, Laidley D, Wong RK, McGowan DR, Vallis KA. Cumulative Absorbed Dose and Successive Cyclic Reduction in Absorbed Dose Predict Response to 177Lu-DOTATATE in Neuroendocrine Tumors. J Nucl Med. 2026 May 1;67(5):751-757. doi: 10.2967/jnumed.125.271039.

Drugs

Indications