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Clinical Study of 68Ga Labeled HER2 Affibody Analogues

A

Air Force Military Medical University of People's Liberation Army

Status and phase

Unknown
Early Phase 1

Conditions

HER2-positive Breast Cancer and Gastric Cancer

Treatments

Drug: 68Ga labeled HER2 Affibody

Study type

Interventional

Funder types

Other

Identifiers

NCT05411432
KY20202093-F-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • patients with breast or gastric cancers: diagnosed by MR and ready for surgery

Exclusion criteria

  • refuse or cannot endure surgery pregnant women

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Central trial contact

Jing Wang, M.D, Ph.D

Data sourced from clinicaltrials.gov

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