Clinical Study of 68Ga Labeled HER2 Affibody Analogues
- Conditions
- HER2-positive Breast Cancer and Gastric Cancer
- Registration Number
- NCT05411432
- Lead Sponsor
- Xijing Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 56
- patients with breast or gastric cancers: diagnosed by MR and ready for surgery
- refuse or cannot endure surgery pregnant women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method SUV of organs 0, 0.5, 1.0, 2.0,3.0 and 4.0 hours after injection The standardized uptake values (SUV) in deferent organs
- Secondary Outcome Measures
Name Time Method radioactivity of blood sample 1, 3, 5, 10, 30,60, 90, 120, 150, 180 and 240 minutes 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.