99mTc-3PRGD2 SPECT/CT in Esophagus Cancer Patients
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is an open-label single photon emission computed tomography / computed tomography
      (SPECT/CT) study to investigate the safety and diagnostic performance of
      99mTc-HYNIC-3PEG4-E[c(RGDfK)2) (99mTc-3PRGD2) in esophagus cancer patients. A single dose of
      nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously
      injected into the patients in suspicion of esophagus cancer. Visual and semiquantitative
      method will be used to assess the whole-body planar and thoracic SPECT/CT images. Any adverse
      events will be collected from the patients.
    

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 translation of 99mTc-3PRGD2, an open-label SPECT/CT
      study was designed to investigate the safety and diagnostic performance of 99mTc-3PRGD2 in
      esophagus cancer patients. A single dose of nearly 11.1 MBq/kg body weight 99mTc-3PRGD2 ( ≤
      20 µg 3PRGD2) will be intravenously injected into the esophagus cancer patients. Visual and
      semiquantitative method will be used to assess the whole-body planar and thoracic SPECT/CT
      images. Adverse events will also be observed in the patients.
    

Intervention name(s): 99mTc-3PRGD2
Intervention type(s): Drug
Intervention description(s): For patients in suspicion of esophagus cancer, single intravenous bolus injection of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 on day one of the treatment period, whole-body planar and thoracic SPECT/CT to determine the accumulation of 99mTc-3PRGD2 in the tumors and the other parts of the body.
Other intervention name(s): 99mTc-HYNIC-3PRGD2
Intervention MeSH terms: HYNIC-3PRGD(2)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic