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NCT Number: NCT03546478

99mTc Labelled Affibody SPECT/CT Imaging for Breast Cancer HER2 Characterization

This is an open-label single photon emission tomography/computed tomography (SPECT/CT) study to investigate the diagnostic performance and evaluation efficacy of 99mTc-ABH2 in breast cancer patients. A single dose of 370±54 Mega-Becquerel (MBq)99mTc-ABH2 will be injected intravenously. Visual and semiquantitative method will be used to assess the SPECT/CT images.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

29 year–76 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

About this study

99mTc-ABH2 is an affibody probe targeting HER2. The investigators will determine the use of 99mTc-ABH2 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-ABH2 SPECT/CT in stratifying breast cancer.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with breast cancer before surgery Conventional imaging within 1 month Signed written consent Age above 29 years Female

Exclusion criteria

Pregnancy Breastfeeding Renal function: serum creatinine > 3.0 mg/dl Known allergy against affibody Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance

Treatment and study plan

99mTc-ABH2

Biological

99mTc-ABH2 were injected into the patients before the SPECT/CT scans

Other names: 99mTc labelled HER2 affibody

Primary outcomes

  1. T/B

    Time frame: 1 year

    Target/Background ratio of 99mTc-ABH2 SPECT/CT in Diagnosis of HER2-positive breast cancer

Secondary outcomes

  1. Adverse events collection

    Time frame: 1 week

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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jun 6, 2018
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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