Status:
UNKNOWN
177Lu-DOTA-EB-TATE in Patients With Advanced Neuroendocrine Tumors
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 dos...
Detailed Description
Neuroendocrine tumors (NETs) are a heterogeneous group of neoplasms that can develop anywhere in the body and arise from neuroendocrine cells throughout the endocrine system. The most recent NCCN guid...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03308682
Start Date
April 30 2017
End Date
May 1 2018
Last Update
October 12 2017
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730