177Lu-DOTA-EB-TATE in Patients With Advanced Neuroendocrine Tumors
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ClinicalTrials.gov Identifier: NCT03308682 |
Recruitment Status : Unknown
Verified May 2017 by Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : October 12, 2017
Last Update Posted : October 12, 2017
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Condition or disease | Intervention/treatment | Phase |
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Neuroendocrine Tumors | Drug: 177Lu-DOTA-EB-TATE | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety and Dosimetry of a Long-lasting Radiolabeled Somatostatin Analogue 177Lu-DOTA-EB-TATE in Patients With Advanced Metastatic Neuroendocrine Tumors |
Actual Study Start Date : | April 30, 2017 |
Estimated Primary Completion Date : | May 1, 2018 |
Estimated Study Completion Date : | May 1, 2018 |

Arm | Intervention/treatment |
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Experimental: 177Lu-DOTA-EB-TATE dosimetry calculation
The patients were intravenously injected with single dose 0.50GBq-0.70GBq (13.5-18.9 mCi) of 177Lu-DOTA-EB-TATE and monitored at 2, 24, 72, 120 and 168 hours post-injection.
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Drug: 177Lu-DOTA-EB-TATE
The patients were intravenously injected with single dose 0.50GBq-0.70GBq (13.5-18.9 mCi) of 177Lu-DOTA-EB-TATE and monitored at 2, 24, 72, 120 and 168 hours post-injection. |
- Standardized uptake value of 177Lu-DOTA-EB-TATE in normal organs and metastatic neuroendocrine Tumors [ Time Frame: 1 year ]The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value at each time point in normal organs and metastatic neuroendocrine tumors will be measured.
- Adverse events collection [ Time Frame: 2 months ]Adverse events within 2 months after the injection and scanning of patients will be followed and assessed

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Adults who had neuroendocrine tumors and had metastasized, that were with histologically confirmed, inoperable and had showed disease progression according to Response Evaluation Criteria in Solid Tumors [RECIST]. Tumors were with well-differentiated histologic features and a Ki67 index of 0 to 20%. Target tumors were selected from CT, MRI, and 68Ga-DOTA-TATE PET/CT, with confirmed somatostatin receptor-expressing and at least one lesion has higher uptake than that of normal liver parenchyma on 68Ga-DOTA-TATE PET imaging within 1 weeks.
Exclusion Criteria:
- The exclusion criteria were a serum creatinine level of more than 150 μmol per liter, baseline measured GFR of less than 50 mL/min/1.73 m2, determined by 99mTc-DTPA renal function examination, a hemoglobin level of less than 8.0 g/dl, a white-cell count of less than 2.0× 109/L, a platelet count of less than 75 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia, and pregnancy or breastfeeding.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308682
Contact: Jingjing Zhang, M.D.,PhD. | +86 10 69154196 | zhangjingjingtag@163.com |
China, Beijing | |
Peking Union Medical College Hospital | Recruiting |
Beijing, Beijing, China, 100730 | |
Contact: Zhaohui Zhu, M.D.,PhD. |
Study Chair: | Zhaohui Zhu, M.D.,PhD. | Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College |
Responsible Party: | Peking Union Medical College Hospital |
ClinicalTrials.gov Identifier: | NCT03308682 |
Other Study ID Numbers: |
PUMCH-EB-3 ZIAEB000073 ( U.S. NIH Grant/Contract ) |
First Posted: | October 12, 2017 Key Record Dates |
Last Update Posted: | October 12, 2017 |
Last Verified: | May 2017 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |