99mTc-MIRC213 SPECT/CT for the Detection of HER2-positive Breast Cancer

Breast Cancer Clinical Trial

Official title:

99mTc-MIRC213 SPECT/CT for the Detection of HER2-positive Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05622240
• Other study ID #: PUMCH-MIRC213
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 7, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: Peking Union Medical College Hospital
• Contact: Rongxi Wang, Dr
• Phone: +8615584172170
• Email: zhzwrx.123[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study to investigate the imaging performance of 99mTc-MIRC213 in breast cancer patients. A single dose of 11.1-14.8Mega-Becquerel (MBq) per kilogram body weight 99mTc-MIRC213 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

Description:

99mTc-MIRC213 is an nano affibody probe targeting HER2. The investigators will determine the use of 99mTc-MIRC213 SPECT/CT in the detection of HER2- positive breast cancer, and to compare its diagnostic value with routine immunohistochemistry (IHC) pathological staining. HER2 imaging, specifically to HER2 receptor expressed on malignant breast cancer cell surface, might help for targeted therapy with monoclonal antibody such as trastuzumab in breast cancer, and may improve the treatment strategy of breast cancer. The investigator will determine the use of 99mTc-MIRC213 SPECT/CT in stratifying breast cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 85 Years

Eligibility

Inclusion Criteria:

• patients in suspicion of breast cancer by mammography or ultrasonography,and being able to provide basic information and sign the written informed consent form

Exclusion Criteria:

• The exclusion criteria included claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study, and undergoing any preceding local or systemic therapies that might interfere with HER2 binding.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 99mTc-MIRC213
99mTc-MIRC213 were intravenous injected into the patients before the wholebody and SPECT/CT scans

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College	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	Dosimetric distribution of radiopharmaceuticals	Input the data of 5-6 patients into HERMES software, and analyze the dose distribution of radioactive drugs in human body through HERMES software	2 months
Primary	Standardized uptake value	The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast tumor will be measured. SUV were obtained by a self-made software and referring to phantom study.If the SUV value cannot be obtained, the COUNTS of target organ/background ratio between the lesion and surrounding tissues shall be used for calculation.	1 year
Secondary	Adverse events collection	Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed	1 year