99mTc-3PRGD2 SPECT/CT in Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This is an open-label SPECT/CT (single photon emission computed tomography / computed
      tomography) study to investigate clinical study of 99mTc-3PRGD2 SPECT/CT in diagnosis and
      efficacy evaluation of breast cancer. Diagnostic group: for patients in suspicion of breast
      cancer. The standard of truth for diagnosis was based on histopathologic findings after
      surgical removal of the tumor or a definite diagnosis from fine needle aspiration biopsy. A
      single dose of nearly 0.3 mCi/kg (milli-Curie/kilogram) body weight of 99mTc-3PRGD2 ( ≤ 20 µg
      3PRGD2) will be intravenously injected into the patients. Visual and semiquantitative method
      will be used to assess the whole-body planar and lesions SPECT/CT images.

      Efficacy evaluation group: for patients firstly diagnose with malignant tumors (breast
      cancer), and prepare to chemotherapy(including neoadjuvant chemotherapy) or radiotherapy. The
      standard of truth for diagnosis was based on histopathologic findings after fine needle
      aspiration biopsy. A single dose of nearly 0.3 mCi/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg
      3PRGD2) will be intravenously injected into the patients before treatment, the second period,
      sixth period. Visual,semiquantitative method will be used to assess the whole-body planar and
      lesions SPECT/CT images. By comparing with result of the other related imaging, for instance,
      PET/CT (positron emission tomography/computed tomography), CT (computed tomography), MRI
      (magnetic resonance imaging), Doppler Ultrasound, Mammography, etc.
    

Detailed description: 
      Integrin αvβ3 is an important member of integrin receptor family and expressed preferentially
      on the activated endothelial cells of angiogenesis and some types of tumor cells, but not or
      very low on the quiescent vessel cells and other normal cells. Therefore, the integrin αvβ3
      receptor is becoming a valuable target for diagnosis and response evaluation of malignant
      tumors.

      The tri-peptide sequence of arginine-glycine-aspartic acid (RGD) can specifically bind to the
      integrin αvβ3 receptor. Accordingly, a variety of radiolabeled RGD-based peptides have been
      developed for non-invasive imaging of integrin αvβ3 expression via single photon emission
      computed tomography (SPECT)or positron emission tomography (PET). Among all the RGD
      radiotracers studied, several RGD monomers have been investigated in clinical trials, and the
      preliminary results demonstrated specific imaging of various types of tumors, and the tumor
      uptake correlated well with the level of integrin αvβ3 expression. Recently, several RGD
      dimeric peptides with PEG linkers have been studied. The new types of RGD peptides showed
      much higher in vitro integrin αvβ3-binding affinity than the single RGD tri-peptide sequence,
      and importantly, they exhibited significantly increased tumor uptake and improved in vivo
      kinetics in animal models. As a representative, 99mTc-3PRGD2 could be easily prepared and
      exhibited excellent in vivo behaviors in animal models. No adverse reactions are observed in
      animal models to date.

      For the further interests in clinical trial of 99mTc-3PRGD2, an open-label SPECT/CT (single
      photon emission computed tomography / computed tomography) study to investigate 99mTc-3PRGD2
      SPECT/CT in diagnosis and efficacy evaluation of breast cancer. A single dose of nearly 0.3
      mCi/kg body weight 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the
      patients. Visual and semiquantitative method will be used to assess the whole-body planar and
      lesions SPECT/CT images. Adverse events will also be observed in the patients.
    

Intervention name(s): 99mTc-3PRGD2
Intervention type(s): Radiation
Intervention description(s): Diagnostic group：For patients in suspicion of breast cancer, single intravenous bolus injection of nearly 0.3 mCi/kg body weight of 99mTc-3PRGD2 on day one of the treatment period, whole-body planar and lesions SPECT/CT to determine the accumulation of 99mTc-3PRGD2 in the tumors and the other parts of the body.
Efficacy evaluation group：patients firstly diagnose with malignant lesions ,and prepare to chemotherapy(including neoadjuvant chemotherapy) or radiotherapy.the same dose of 99mTc-3PRGD2 will be intravenously injected into the patients before treatment ,the second period,the sixth period( almost three months after the initial treatment)，whole-body planar and lesions SPECT/CT to assess the value of 99mTc-3PRGD2 in evaluation of cancers.
Other intervention name(s): 99mTc-HYNIC-3PRGD2
Intervention MeSH terms: HYNIC-3PRGD(2)
Intervention model: Single Group Assignment
Intervention model description: The participants were underwent the 99mTc-3PRGD2 imaging and 18F-FDG imaging within one week.
Masking: None (Open Label)
Primary purpose: Diagnostic