A Study of 99mTc-3PRGD2 Injection in Lung Cancer Patient
Condition: Lung Cancer Metastatic
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The study drug Technetium [99mTc] Hydrazinonicotinamide PEGylated Bicyclic RGD Peptide
      Injection（99mTc-3PRGD2） of this study is a novel 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 the image of tumor tissue can be obtained by SPECT/CT,
      This can be used for molecular imaging diagnosis and individualized treatment of common
      tumors.

      The primary objective of this study was to evaluate the efficacy of 99mTc-3PRGD2 for the
      diagnosis of lymph node metastasis in lung tumors. The minor objective was to evaluate the
      efficacy of 99mTc-3PRGD2 in the differential diagnosis of benign and malignant lung tumors
      and the safety of 99mTc-3PRGD2 in vivo of humans.
    

Detailed description: 
      This study strictly obeyed to the result by pathological diagnoses standard. The evaluation
      of the efficacy of 99mTc-3PRGD2 in the diagnosis of lymph node metastasis of lung tumors is
      based on a multi-center, open, self-controlled clinical trial.

      This study involves 10 research sites and a total of about 400 qualified patients who met the
      protocol requirements in China, besides, they were previously diagnosed by 18F FDG PET / CT
      with positive results in pulmonary occupying and lymph nodes (hilar or mediastinum) uptake.
      At least 270 participants' surgical pathology report were required. After screening the
      patients, the intravenous injection of 99mTc-3PRGD2 with a dose of 0.3 mCi / kg was
      performed, followed by SPECT / CT plain scan and chest tomography scan. The doctors are
      responsible for patients about whether they should take lymphadenectomy and obtain the
      surgical pathology reports.

      At the same time, the safety of 99mTc-3PRGD2 injection in human body was evaluated. This
      study strictly obeyed to the result by pathological diagnoses standard which uses the
      four-grid table to calculate the accuracy, sensitivity and specificity of 99mTc-3PRGD2
      SPECT/CT diagnosis. Besides, the diagnostic results of 18F-FDG Positron Emission computed
      Tomography/Chest Tomography (PET/CT) were compared to evaluate the effectiveness of
      99mTc-3PRGD2 SPECT/CT in the diagnosis of lymph node metastasis and differential diagnosis of
      benign and malignant lung tumors as well as evaluate the safety of 99mTc-3PRGD2 injection in
      vivo of humans.

      This study invited an independent imaging evaluation committee to evaluate images obtained
      with 18F-FDG PET/CT, 99mTc-3PRGD2 SPECT/CT and enhanced CT.

      Study duration: The start of the study is defined as the date on which the first participant
      signed the Informed Consent Form (ICF); the End Of the Study (EOS) was defined as the end of
      the collection of the final participant safety assessment data.
    

Intervention name(s): 99mTc-3PRGD2
Intervention type(s): Drug
Intervention description(s): Volunteers were injected intravenously and then scanned by SPECT/CT. Drugs use generic name：Technetium [99mTc] Hydrazinonicotinamide PEGylated Bicyclic RGD Peptide Injection dosage form:Injection dosage:0.3mCi/kg
Other intervention name(s): Technetium [99mTc] Hydrazinonicotinamide PEGylated Bicyclic RGD Peptide Injection
Intervention MeSH terms: Arginyl-glycyl-aspartic acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 99mTc-3PRGD2; Integrin ανβ3;; lung cancer