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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04267900
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: 99mTc-HPArk2 Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 99mTc-HPArk2 SPECT/CT for the Detection of HER2-positive Breast Cancer
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 99mTc-HPArk2 SPECT/CT
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.
Drug: 99mTc-HPArk2
99mTc-HPArk2 were injected into the patients before the SPECT/CT scans
Other Name: 99mTc labelled HER2 affibody




Primary Outcome Measures :
  1. Standardized uptake value of 99mTc-HPArk2 in breast tumor [ Time Frame: 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 :
  1. Adverse events collection [ Time Frame: 1 week ]
    Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267900


Contacts
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Contact: Rongxi Wang +8619800370331 pumch_jacobwong@163.com
Contact: Zhaohui Zhu, MD,PHD

Locations
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China, Beijing
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College Recruiting
Beijing, Beijing, China, 100730
Contact: Rongxi Wang, MD    +8619800370331    pumch_jacobwong@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Study Chair: Zhaohui Zhu, MD,PHD Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04267900    
Other Study ID Numbers: PekingUMCH-NM25
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking Union Medical College Hospital:
SPECT/CT
HER2 imaging
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases