drugset / Trial / NCT03308682
177Lu-DOTA-EB-TATE in Patients With Advanced Neuroendocrine Tumors
Phase 1
Unknown
30 enrolled
Peking Union Medical College Hospital
National Institute for Biomedical Imaging and Bioengineering (NIBIB) · collab
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, non-controlled, non-randomized study to investigate the long-lasting radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluation safety and dosimetry of 177Lu-DOTA-EB-TATE in patients with advanced metastatic neuroendocrine tumors. A single dose of 0.50GBq-0.70GBq (13.5-18.9 mCi) of 177Lu-DOTA-EB-TATE will be injected intravenously. and monitored at 2, 24, 72,120 and 168 hours post-injection with semiquantitative method based on quantitative single-photon emission computed tomography/computed tomography (SPECT/CT) performance.
Timeline
- Start
- 2017-04-30
- Primary completion
- 2018-05-01
- Completion
- 2018-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 177Lu-DOTA-EB-TATE | Peptide | 500 mbq | Intravenous |
| Subject | 177Lu-DOTA-EB-TATE | Peptide | 700 mbq | Intravenous |