Overview

177Lu-DOTA-EB-TATE in Patients With Advanced Neuroendocrine Tumors

Status:
Unknown status
Trial end date:
2018-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Peking Union Medical College Hospital
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Treatments:
(177)Lu-DOTA-EB-TATE
Criteria
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.