drugset / Trial / NCT03478358
Treatment Using 177Lu-DOTA-EB-TATE in Patients With Advanced Neuroendocrine Tumors
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective study to investigate the long-lasting radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluate response to 177Lu-DOTA-EB-TATE in patients with advanced metastatic neuroendocrine tumors. Different groups with doses of 0.37GBq-0.74GBq (10-20 mCi) and 1.85GBq (50 mCi)of 177Lu-DOTA-EB-TATE, 3.7GBq (100 mCi)of 177Lu-DOTA-TATE will be injected intravenously. Besides, we evaluated the safety and dosimetry of 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE with and without amino acid infusion. All patients will undergo 68Ga-DOTATATE PET/CT scans before and after the treatment.
Timeline
- Start
- 2017-04-30
- Primary completion
- 2022-12-31
- Completion
- 2023-05-01
Publications
- Jiang Y, Liu Q, Wang G, Zhang J, Zhu Z, Chen X. Evaluation of Safety, Biodistribution, and Dosimetry of a Long-Acting Radiolabeled Somatostatin Analog 177 Lu-DOTA-EB-TATE With and Without Amino Acid Infusion. Clin Nucl Med. 2023 Jun 1;48(6):e289-e293. doi: 10.1097/RLU.0000000000004642. Epub 2023 Apr 18.
- Liu Q, Cheng Y, Zang J, Sui H, Wang H, Jacobson O, Zhu Z, Chen X. Dose escalation of an Evans blue-modified radiolabeled somatostatin analog 177Lu-DOTA-EB-TATE in the treatment of metastatic neuroendocrine tumors. Eur J Nucl Med Mol Imaging. 2020 Apr;47(4):947-957. doi: 10.1007/s00259-019-04530-1. Epub 2019 Dec 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 177Lu-DOTA-EB-TATE | Peptide | 370 mbq | Intravenous |
| Subject | 177Lu-DOTA-EB-TATE | Peptide | 740 mbq | Intravenous |
| Subject | 177Lu-DOTA-EB-TATE | Peptide | 1850 mbq | Intravenous |
| Subject | 177Lu-DOTA-EB-TATE | Peptide | 3700 mbq | Intravenous |
| Subject | 177Lu-DOTATATE | Peptide | 3700 mbq | Intravenous |
| Subject | L-arginine | Small molecule | — | Intravenous |
| Subject | Lysine | Other / unclassified | — | Intravenous |