Clinical Trial · NCT05982626

Study of 68Ga /131I SGMIB-ZT-199 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer

Overview

To evaluate the safety, biodistribution, radiation dosimetry, and uptake in tumor lesions of patients with Her2-positive metastatic breast cancer after injection of \[131I\]/\[68Ga\]SGMIB-ZT-199.

Sponsor

Huashan Hospital

Phase

N/A

Contacts

Fang Xie, PhD (PRINCIPAL_INVESTIGATOR)

Yihui Guan, MD (CONTACT)

guanyihui@hotmail.com

13764308300

ClinicalTrials.gov

NCT05982626

Drug / Compound

SGMIB-ZT-199

Isotope(s):

Target(s):

HER2

Ligand Class: Small Proteins and Antibody Fragments

Linker: SGMIB

Eligibility

Inclusion

Breast cancer patients.
Willing and able to cooperate with all items of this study.
Patients with breast cancer confirmed by histological examination or imaging.
Renal function: serum creatinine less than or equal to the upper limit of the normal range; electrocardiogram: no significant abnormalities.
HER2 positive diagnosis confirmed by puncture by immunohistochemistry or fluorescence in situ hybridization (HER2 positive is defined as immunohistochemistry result of 3+ (IHC 3+); or immunohistochemistry result of 2+/positive in situ hybridization result (IHC 2+/ISH+)).

Exclusion

Severe hepatic or renal insufficiency;
Participation in this study is considered unsuitable by other investigators.
Subjects meeting any of the following criteria will be excluded from the study:
Participation in another study protocol or clinical care within the past year that has resulted in radiation exposure exceeding an effective dose of 50 mSv in addition to the radiation exposure expected from participation in this clinical study.
Pregnant women and other groups unsuitable to receive radiation.
Alcohol allergy, etc.