99mTc-HPArk2 SPECT/CT for the Detection of HER2-positive Breast Cancer

Early Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Drug: 99mTc-HPArk2

• Registration Number: NCT04267900
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study to investigate the diagnostic performance and evaluation efficacy of 99mTc-HPArk2 in breast cancer patients. A single dose of 11.1Mega-Becquerel (MBq) per kilogram body weight 99mTc-HPArk2 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

Detailed Description

99mTc-HPArk2 is an affibody probe targeting HER2. The investigators will determine the use of 99mTc-HPArk2 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-HPArk2 SPECT/CT in stratifying breast cancer.

Study Timeline

• Study Start: 2019-12-07
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
99mTc-HPArk2 SPECT/CT	99mTc-HPArk2	The patients were injected with 11.1 (MBq) per kilogram body weight of 99mTc-HPArk2 in one dose intravenously and underwent SPECT/CT scan 30-60 min later.

Primary Outcome Measures

Name	Time	Method
Standardized uptake value of 99mTc-HPArk2 in breast tumor	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Adverse events collection	1 week	Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China