99mTc-ABH2 SPECT/CT in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ABH2 SPECT/CT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194565
• Other study ID #: PUMCH-ABH2
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: December 2023
• Source: Peking Union Medical College Hospital
• Contact: Yuwei Zhang
• Phone: +8618511071577
• Email: ywzhangwork[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective study will investigate the potential usefulness of 99mTc-ABH2 SPECT/CT in the diagnostic performance and evaluation efficacy of breast cancer.

Description:

This study aims to assess the diagnostic performance of 99mTc-ABH2 SPECT/CT for the detection of HER2-positive primary breast cancer and possible metastases. Visual and semiquantitative methods will be utilized to evaluate the acquired SPECT/CT images. A comparative analysis of tumor imaging data and HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples will further be conducted. Results of HER2 expression imaging may have potential significance in screening and monitoring individuals for targeted therapy with monoclonal antibodies, like Trastuzumab.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• clinically suspected primary breast cancer by mammography or ultrasonography and being able to sign the written informed consent form

Exclusion Criteria:

• pregnancy or lactation, impaired liver or kidney failure, and undergoing any preceding local or systemic therapies that might interfere HER2 binding

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 99mTc-ABH2
Each patient will receive an intravenous injection of 99mTc-ABH2, and undergo a SPECT/CT scan within specified time.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SPECT/CT-based 99mTc-ABH2 uptake value in tumor lesions	Uptake of 99mTc-ABH2 in the lesions will be assessed using SPECT/CT and measured in standardized uptake value (SUV).	1 year