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

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05411432

Enrollment

Registered

2022-06-09

Start date

2022-06-01

Completion date

2023-12-01

Last updated

2022-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HER2-positive Breast Cancer and Gastric Cancer

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.

Interventions

DRUG68Ga labeled HER2 Affibody

inject the tracer to subjects and perform PET/CT scans

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* refuse or cannot endure surgery pregnant women

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Contacts

Primary ContactJing Wang, M.D, Ph.D

wangjing@fmmu.edu.cn86-29-84775449

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026