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HER2 Expression Detection in Breast Cancer Using 99mTc-NM-02

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: NCT04040686
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : December 9, 2020
Sponsor:
Collaborator:
NanoMab Technology (UK) Limited
Information provided by (Responsible Party):
Zhao Jin Hua, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
A 99mTc-labeled anti-HER2-sdAb (99mTc-NM-02) will be developed for SPECT/CT assessment of HER2 expression in breast cancer patients. Its safety, radiation dosimetry and biodistribution, and the relationship between tumor uptake and HER2 immunohistochemistry results will be investigated.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Injection of 99mTc-NM-02 Early Phase 1

Detailed Description:
To evaluate the safety, dosimetry and efficacy of 99m-Tc labeled anti-HER2 single domain antibody (sdAb) (Product Code Name: 99mTc-NM-02) SPECT/ CT imaging of HER2 expression in Breast Cancer and compare it with the existing gold standard " HER2 expression detection" by biopsy tissue immunohistochemistry (IHC) and/or Fluorescence In Situ Hybridization (FISH) method. It is also to establish a new clinical method of non-invasive HER2 expression detection in breast cancer using 99m-Tc labeled anti-HER2 sdAb

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Technetium-99m Labeled Anti-HER2 sdAb (99m-Tc-NM-02) for HER2 Expression Detection in Breast Cancer
Actual Study Start Date : July 29, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Injection of 99mTc-NM-02
All breast cancer patients recruited to the study will be administered 3-12 MBq/kg of 99m-Tc-NM-02 (99m-Tc labeled anti-HER2 sdAb) in a single dose injection
Drug: Injection of 99mTc-NM-02
Patient will be injected with microdose (<100ug) of 99mTc-NM-02 radiotracer
Other Name: anti-HER2 SPECT/CT radiotracer




Primary Outcome Measures :
  1. Visual Assessment of HER2 expression in Breast cancer using 99mTc-NM-02 SPECT/CT Scan [ Time Frame: 1 year ]
    Visual analysis will be carried out by 4 experienced nuclear medicine physicians to observe the uptake of 99m-Tc-NM-02 in breast malignant lesions. A 4 point system will be used to interpret the scans for abnormalities. It is categorised as such: score 0, no abnormal increased uptake; score 1, low increased uptake; score 2, moderate increased uptake; score 3, high increased uptake. The lesion will be considered positive for malignancy if the score is 2 or higher.

  2. Semiquantitative Assessment of Breast and other Metastatic Lesions in 99mTc-NM-02 SPECT/CT Scan [ Time Frame: 1 year ]
    Each subject will be administered 3-12 MBq/kg of 99mTc-NM-02 and the semiquantitative analysis of the region of interest (ROI) will be performed in breast and other metastatic lesions. Higher level of HER2 expression (Tumor proportion score, TPS), higher ROI in tumor.

  3. Safety of 99mTc-NM02 through Adverse Event Monitoring [ Time Frame: 2 days ]
    Subjects will be observed for safety after administration of 99mTc-NM-02, and will do follow up at 48h p.i. Subjects will do blood test to observe for abnormalities in clinical parameters and compare to baseline results.

  4. Safety of 99m-Tc-NM-02 through Adverse Event Monitoring [ Time Frame: 7 days ]
    Subjects will be observed for safety after administration of 99mTc-NM-02, and will do follow up at 7d p.i. Subjects will be contacted by investigator by phone and asked several questions related to subject's health after 99m-Tc-NM-02 injection and concomitant drugs.


Secondary Outcome Measures :
  1. HER2 Expression Heterogeneity [ Time Frame: 1 year ]
    Biopsy tissue sample IHC and FISH HER2 test results from subject's primary tumor will indicate its HER2 expression level, this results will be compared with our radiotracer uptake in the primary tumor and will look for heterogeneity while observing for uptake in other metastatic lesions.



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

Inclusion Criteria:

  1. Adult female, age 18 years or older
  2. Prior diagnosis of breast cancer
  3. Willing to participate in this study and given written informed consent
  4. AST, ALT, BUN, Cr not more than double the normal values
  5. Subjects of childbearing potential must be willing to undergo a pregnancy test prior to enrolment

Exclusion Criteria:

  1. Pregnancy (subjects with a positive pregnancy test at baseline screening period or who are planning to become pregnant during the study period)
  2. Breastfeeding (subjects in lactation)
  3. No biopsy tissue sample can be provided for HER2 expression detection
  4. Subjects with pacemakers
  5. Hepatitis B virus infection (including carriers) at screening, ie hepatitis B surface antigen (HBsAg) positive, or hepatitis C antibody (anti-HCV) positive, or acquired immunodeficiency disease (HIV) infected, or serum syphilis positive person
  6. Abnormal liver function during baseline screening period : AST or ALT> 2 times the upper limit of normal value (ULN), if the marginal increase of a single index is judged as having no clinical significance by the investigator, it can be retested during the screening period. Once, if ≤ 2 times ULN after retesting, consider enrolling).
  7. Impaired renal function during screening: serum creatinine or urea nitrogen > 1.5 times ULN.
  8. Within 4 months prior to the baseline screening period , myocardial infarction or other cardiac events requiring hospitalization (unstable angina, etc.), cerebrovascular accident, transient ischemic attack, acute congestive Heart failure or severe arrhythmia (ventricular arrhythmia, atrioventricular block above II)
  9. Subjects with pulmonary embolism or deep vein thrombosis
  10. Various infections that the investigators consider unsuitable for study, including but not limited to patients with various infections requiring further treatment, such as urinary tract infections, respiratory infections, and diabetic foot infections.
  11. Patients with abnormal thyroid function during baseline screening period (including but not limited to active hyperthyroidism, hypothyroidism or Hashimoto's thyroiditis)

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): NCT04040686


Contacts
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Contact: Jinhua Zhao, PhD 0086-21-63240090 ext 4940 zhaojinhua1963@126.com

Locations
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China, Shanghai
Shanghai General Hospital Recruiting
Shanghai, Shanghai, China, 200080
Contact: Jinhua Zhao, PhD    0086-21-63240090 ext 4940    zhaojinhua1963@126.com   
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
NanoMab Technology (UK) Limited
Investigators
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Principal Investigator: Jinhua Zhao, PhD Shanghai General Hospital Nuclear Medicine Dept
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhao Jin Hua, MD, Director Department of Nuclear Medicine, Principal Investigator, Professor, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT04040686    
Other Study ID Numbers: [2019]52
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 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 Zhao Jin Hua, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
HER2
single domain antibody (sdAb)
SPECT/CT imaging
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases