The purpose of this study is to assess the dosimetric properties of the positron emission tomography (PET) imaging probe 68Ga labeled HER2 Affibody analogues and preliminarily evaluate its diagnosis value in patients with breast or gastric tumors.
6 healthy volunteers with whole-body PET/CT scans at 0-1.0, 2.0, 3.0 and 4.0 hours after tracer injection (mean dose, 4.93 ± 0.10 mCi) will be performed. During the imaging period, 1 mL blood samples will be obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, 180 and 240 minutes after the injection, for time-activity curve calculations. The estimated radiation doses will be calculated by using OLINDA/EXM software. 50 patients with breast or gastric tumors will be enrolled for the clinical study, they will be performed with both 68Ga-HER2 Affibody PET/CT and18F-FDG PET/CT scans before surgery. The preoperative images are compared and correlated with the pathologically report. Next, the expression of HER2 will be determined by immunohistochemical staining of the resected brain tumor tissues.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
56
inject the tracer to subjects and perform PET/CT scans
SUV of organs
The standardized uptake values (SUV) in deferent organs
Time frame: 0, 0.5, 1.0, 2.0,3.0 and 4.0 hours after injection
radioactivity of blood sample
blood samples are obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, 180 and 240 minutes after the injection, for time-radioactivity curve calculations.
Time frame: 1, 3, 5, 10, 30,60, 90, 120, 150, 180 and 240 minutes
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