A Study of 99mTc-3PRGD2 Injection in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study drug 99mTc-3PRGD2 of this study is a new radioactive diagnostic preparation for
      clinical use as a nuclear medicine molecular probe for tumor SPECT/CT imaging.

      After 99mTc-3PRGD2 is injected into the body, it is specifically taken up by integrin
      receptor-positive tumor tissue, and tumor tissue is developed by SPECT/CT, which can be used
      for molecular imaging diagnosis and individualized treatment of common tumors.

      The primary objectives of this study is to examine the pharmacokinetics the safety of
      99mTc-3PRGD2 injection in healthy volunteers, as well as the biodistribution in the human
      body and to estimate the dose of internal radiation absorbed. This study provides the basis
      for the design of phase II clinical research programs.
    

Detailed description: 
      To a large extent, cancer treatment outcomes depend on the accurate diagnosis and staging of
      the disease. An important basis for early diagnosis of malignant tumors is medical imaging.
      Single-Photon Emission Computed Tomography (SPECT) and Positron Emission Tomography (PET) are
      most well-developed nuclear medicine procedures based on the measurement of radiolabeled
      tracer molecules.

      These radiotracers allow biologic processes to be measured and whole body images to be
      obtained, which will demonstrate exact locations of radiotracer accumulation. Functional
      imagings of SPECT and PET provide specific information which is not available from standard
      medical imaging modalities such as ultrasound, X-ray, computerized tomography (CT) or
      magnetic resonance imaging (MRI).

      The test drug in this study is a new radioactive diagnostic preparation, consisting of
      radiochemical (Sodium Pertecheetate [99mTc] Injection) and a kit (including Three core
      ligands, HYNIC-3PRGD2, Tricine, TPPTS). Before administration,
      99mTc:HYNIC-3PRGD2:Tricine:TPPTS (1:1:1:1) chelate compound (99mTc-3PRGD2) will be prepared
      as per standard opration presedure, which will be used as a molecular probe for SPECT/CT
      imaging.

      The core ligand HYNIC-3PRGD2 is a novel RGD dimer that specifically binds to the integrin
      αvβ3 receptor with high selectivity and affinity. Integrin αvβ3 is highly expressed in tumor
      neovascularization. After injection, 99mTc-3PRGD2 will be specifically taken up by the
      integrin receptor-positive tumor tissue, then be imaged by SPECT/CT. The product can be used
      for molecular imaging diagnosis and individualized treatment for common tumors such as lung
      cancer and breast cancer are performed.

      The primary objectives of this study is to examine the pharmacokinetics the safety of
      99mTc-3PRGD2 injection in healthy volunteers, as well as the biodistribution in the human
      body and to estimate the dose of internal radiation absorbed. This study provides the basis
      for the design of phase II clinical research programs.
    

Intervention name(s): 99mTc niacinamide polyethylene glycol bicyclic RGD peptide (99mTc-3PRGD2)
Intervention type(s): Drug
Intervention description(s): Single dose
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids; Arginyl-glycyl-aspartic acid
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment drug:0.3mCi/kg
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 99mTc-3PRGD2; Integrin ανβ3; Dosimetry