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

HER2-positive Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05982626
• Other study ID #: KY2023-545
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Huashan Hospital
• Contact: Yihui Guan, MD
• Phone: 13764308300
• Email: guanyihui[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Breast cancer patients.

1. Women aged between 18 and 75 years old.

2. Patients with breast cancer confirmed by histological examination or imaging.

3. 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+)).

4. Renal function: serum creatinine less than or equal to the upper limit of the normal range; electrocardiogram: no significant abnormalities.

5. Patients of childbearing age can cooperate with contraception.

6. Willing and able to cooperate with all items of this study.

Exclusion Criteria:

• Subjects meeting any of the following criteria will be excluded from the study:

1. Severe hepatic or renal insufficiency;

2. 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.

3. Participation in this study is considered unsuitable by other investigators.

4. Pregnant women and other groups unsuitable to receive radiation.

5. Alcohol allergy, etc.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Radiation:
• 68Ga/131I-SGMIB-ZT-199
68Ga-SGMIB-ZT-199: PET imaging; 131I-SGMIB-ZT-199: SPECT imaging.

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosimetry	To confirm biodistribution and absorbed doses of whole body, tumor lesions, and organs from [131I]SGMIB-ZT-199, assessed by PET/SPECT imaging.	about 24hours from time of injection
Secondary	Safety Assessment	Incidence and severity of adverse events (AEs) as assessed by CTCAE v4.0	From administration of [131I]SGMIB-ZT-199 until 1 week after injection