NCT05411432

Clinical Study of 68Ga Labeled HER2 Affibody Analogues

Clinical Study of 68Ga Labeled HER2 Affibody Analogues in Healthy Volunteers and Patients With Breast or Gastric Tumors

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• HER2-positive Breast Cancer and Gastric Cancer

Interventions

Type	Name	Description
DRUG	68Ga labeled HER2 Affibody	inject the tracer to subjects and perform PET/CT scans

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2022-06-09
• Last updated: 2022-06-09