<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04504565</url>
  </required_header>
  <id_info>
    <org_study_id>MIC-ESO-003</org_study_id>
    <nct_id>NCT04504565</nct_id>
  </id_info>
  <brief_title>99m Tc-3PRGD2 SPECT/CT Imaging in the Diagnosis of Lymph Node Metastasis of Esophageal Carcinoma</brief_title>
  <official_title>The Efficacy of 99mTc-3PRGD2 SPECT/CT Imaging in the Diagnosis of Lymph Node Metastasis of Esophageal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fifth Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fifth Affiliated Hospital, Sun Yat-Sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The esophageal squamous cell carcinoma (ESCC) has high prevalence and mortality in China,&#xD;
      which become a severe challenge for public health. The molecular imaging technology has been&#xD;
      developed for visualization and precise diagnosis of the tumors. Integrin αvβ3 is a specific&#xD;
      marker for tumor. Noninvasive visualization and quantitative analysis of integrin αvβ3&#xD;
      expression provide new opportunities for tumor diagnosis, identification and efficacy&#xD;
      monitoring. The peptide containing Arg-Gly-Asp (RGD) can specifically bind to integrin αvβ3&#xD;
      receptor with high selectivity and affinity to achieve the detecting tumor .The SPECT/CT with&#xD;
      99mTc-3PRGD2 has a high specificity in the diagnosis of mediastinal lymphnode metastasis and&#xD;
      a greater value in the decision-making of lymphnode dissection.&#xD;
&#xD;
      This study is a single-center self-controlled study, It is planned to enroll 30 patients with&#xD;
      esophageal cancer , preliminarily confirmed by endoscopic biopsy, . After intravenous&#xD;
      injection of 0.3 mCi/kg of 99mTC-3PRGD2, patients underwent single-photon emission computed&#xD;
      tomography/computed tomography (SPECT/CT) examination.Subsequently, the patients received&#xD;
      chest/abdomen enhanced CT and 18F fluorodeoxyglucose (18F-FDG) positron emission computed&#xD;
      tomography /CT (PET/CT) for diagnosis. According to the determination of the researcher,&#xD;
      patients who were suitable for surgery received surgery to obtain surgical pathology; For&#xD;
      patients who were not suitable for surgery, ultrasound-guided lyphnode biop was performed .In&#xD;
      this study, pathological specimens were obtained from gastroscopy, surgical pathology, or&#xD;
      ultrasound-guided lymph node biopsy. The diagnostic accuracy, sensitivity , specificity and&#xD;
      safety of SPECT/CT with 99mTc-3PRGD2 were evaluated and compared with PET-CT and enhanced CT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Screening period All patients will be during the screening screening assessment, specific&#xD;
      include: the signing of the ICF, demographic data, drug allergy history and history, height,&#xD;
      weight, physical examination, vital signs, electrocardiogram (ECG) examination, laboratory&#xD;
      examination, blood pregnancy test records (if applicable), endoscopic biopsy, AE and drug&#xD;
      combination, check into/standard. Qualified patients will enter the administration period&#xD;
      after screening and confirmation. Administration period (from Administration to safety&#xD;
      follow-up) day of administration (study day 1): before administration of the experimental&#xD;
      drug, 12-lead ECG, laboratory test (fasting) and vital signs were measured. Subsequently, the&#xD;
      experimental drug was injected intravenously at 0.3 ± 20% mCi/kg, and subjects underwent&#xD;
      urination and SPECT/CT examination 40 min after administration. AE and combined medication&#xD;
      were recorded. The next day after administration (day 2 of the study): 12-lead ECG,&#xD;
      laboratory examination (fasting), vital signs were measured, AE and combined medication were&#xD;
      recorded. Between the administration of 99mTc-3PRGD2 and the safety follow-up, the&#xD;
      investigator determined that chest/abdomen enhanced CT and PET/CT were performed at an&#xD;
      optional date.&#xD;
&#xD;
      Safety follow-up (day 14±2 of the study or before the next clinical intervention, whichever&#xD;
      is shorter) :&#xD;
&#xD;
      12 lead ECG, laboratory test (fasting), measurement of vital signs, blood pregnancy (women of&#xD;
      childbearing age only), AE and combined medication were recorded.Lymph node histopathology&#xD;
      was obtained by surgery in patients suitable for surgery, and by ultrasound-guided lymph node&#xD;
      biopsy in patients unsuitable for surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the accuracy of SPECT/CT with 99mTc-3PRGD2 in the diagnosis of lymph node metastasis</measure>
    <time_frame>14 days</time_frame>
    <description>To evaluate the accuracy of SPECT/CT with 99mTc-3PRGD2 in the diagnosis of lymph node metastasis of esophageal carcinoma，according to the pathological analysis, according to the pathological analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the sensitivity of SPECT/CT with 99mTc-3PRGD2 in the diagnosis of lymph node metastasis</measure>
    <time_frame>14 days</time_frame>
    <description>To evaluate the sensitivity of SPECT/CT with 99mTc-3PRGD2 in the diagnosis of lymph node metastasis of esophageal carcinoma，according to the pathological analysis, compared with PET-CT and enhanced CT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Incidence of Adverse Events</measure>
    <time_frame>14 days</time_frame>
    <description>To evaluate the safety of 99mTc-3PRGD2 in SPECT/CT in the diagnosis of lymph node metastasis of esophageal carcinoma</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Esophageal Cancer</condition>
  <condition>Lymph Node Metastases</condition>
  <condition>Diagnoses Disease</condition>
  <arm_group>
    <arm_group_label>99mTc-3PRGD2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intravenous injection of 0.3 mCi/kg of 99mTC-3PRGD2, patients underwent single-photon emission computed tomography/COMPUTED tomography (SPECT/CT) examination.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>99mTc-3PRGD2</intervention_name>
    <description>intravenous injection of 0.3 mCi/kg of 99mTc-3PRGD2</description>
    <arm_group_label>99mTc-3PRGD2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Esophageal cancer was confirmed by Endoscopic biopsy&#xD;
&#xD;
          -  Clinical laboratory tests (heart, liver, kidney, blood) and other indicators are in&#xD;
             the normal range, or the abnormalities have no clinical significance (NCS), or the&#xD;
             abnormalities have clinical significance (CS) but do not affect the implementation of&#xD;
             surgery or lymph node puncture;&#xD;
&#xD;
          -  The patient being able to follow scheduled visits, treatment plans and laboratory&#xD;
             tests.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female patients who plan to become pregnant within 6 months, or are pregnant or&#xD;
             breastfeeding;&#xD;
&#xD;
          -  Allergic to test drugs, allergic constitution or multiple drugs;&#xD;
&#xD;
          -  Weight over 100 kg;&#xD;
&#xD;
          -  Claustrophobia;&#xD;
&#xD;
          -  Cannot tolerate both arms raised and supine for 15-30 minutes;&#xD;
&#xD;
          -  The investigator considers it inappropriate to participate in this clinical trial;&#xD;
&#xD;
          -  The patient participated in or participating in other clinical trials within the past&#xD;
             3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hong Shan, PhD</last_name>
    <phone>+86-18826913336</phone>
    <email>shanhong@mail.sysu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiaojin Wang, Master</last_name>
    <phone>+86-13798967219</phone>
    <email>wangxj55@mail.sysu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Fifth Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Zhuhai</city>
        <state>Guangdong</state>
        <zip>519000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaojin Wang, MD</last_name>
      <phone>+86-13798967219</phone>
      <email>wangxj55@mail.sysu.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Zhang Z, Zhao X, Ding C, Wang J, Zhang J, Wang F. (99m)Tc-3PRGD2 SPECT/CT Imaging for Monitoring Early Response of EGFR-TKIs Therapy in Patients with Advanced-Stage Lung Adenocarcinoma. Cancer Biother Radiopharm. 2016 Sep;31(7):238-45. doi: 10.1089/cbr.2016.2052. Epub 2016 Aug 26.</citation>
    <PMID>27563805</PMID>
  </results_reference>
  <results_reference>
    <citation>Jin X, Liang N, Wang M, Meng Y, Jia B, Shi X, Li S, Luo J, Luo Y, Cui Q, Zheng K, Liu Z, Shi J, Li F, Wang F, Zhu Z. Integrin Imaging with 99mTc-3PRGD2 SPECT/CT Shows High Specificity in the Diagnosis of Lymph Node Metastasis from Non-Small Cell Lung Cancer. Radiology. 2016 Dec;281(3):958-966. doi: 10.1148/radiol.2016150813. Epub 2016 Jul 29.</citation>
    <PMID>27479638</PMID>
  </results_reference>
  <results_reference>
    <citation>Ji B, Chen B, Wang T, Song Y, Chen M, Ji T, Wang X, Gao S, Ma Q. (9)(9)mTc-3PRGD(2) SPECT to monitor early response to neoadjuvant chemotherapy in stage II and III breast cancer. Eur J Nucl Med Mol Imaging. 2015 Aug;42(9):1362-70. doi: 10.1007/s00259-015-3062-1. Epub 2015 May 7.</citation>
    <PMID>25947573</PMID>
  </results_reference>
  <results_reference>
    <citation>Ma Q, Min K, Wang T, Chen B, Wen Q, Wang F, Ji T, Gao S. (99m)Tc-3PRGD 2 SPECT/CT predicts the outcome of advanced nonsquamous non-small cell lung cancer receiving chemoradiotherapy plus bevacizumab. Ann Nucl Med. 2015 Jul;29(6):519-27. doi: 10.1007/s12149-015-0975-5. Epub 2015 Apr 25.</citation>
    <PMID>25911312</PMID>
  </results_reference>
  <results_reference>
    <citation>Ma Q, Chen B, Gao S, Ji T, Wen Q, Song Y, Zhu L, Xu Z, Liu L. 99mTc-3P4-RGD2 scintimammography in the assessment of breast lesions: comparative study with 99mTc-MIBI. PLoS One. 2014 Sep 24;9(9):e108349. doi: 10.1371/journal.pone.0108349. eCollection 2014.</citation>
    <PMID>25250628</PMID>
  </results_reference>
  <results_reference>
    <citation>Liu L, Song Y, Gao S, Ji T, Zhang H, Ji B, Chen B, Jia B, Wang F, Xu Z, Ma Q. (99)mTc-3PRGD2 scintimammography in palpable and nonpalpable breast lesions. Mol Imaging. 2014;13(5). doi: 10.2310/7290.2014.00010.</citation>
    <PMID>24825112</PMID>
  </results_reference>
  <results_reference>
    <citation>Ma Q, Ji B, Jia B, Gao S, Ji T, Wang X, Han Z, Zhao G. Differential diagnosis of solitary pulmonary nodules using (9)(9)mTc-3P(4)-RGD(2) scintigraphy. Eur J Nucl Med Mol Imaging. 2011 Dec;38(12):2145-52. doi: 10.1007/s00259-011-1901-2. Epub 2011 Aug 27.</citation>
    <PMID>21874323</PMID>
  </results_reference>
  <results_reference>
    <citation>Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.</citation>
    <PMID>26808342</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Esophageal Neoplasms</mesh_term>
    <mesh_term>Lymphatic Metastasis</mesh_term>
    <mesh_term>Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04504565
org study id: MIC-ESO-003
nct id: NCT04504565
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The esophageal squamous cell carcinoma (ESCC) has high prevalence and mortality in China,
      which become a severe challenge for public health. The molecular imaging technology has been
      developed for visualization and precise diagnosis of the tumors. Integrin αvβ3 is a specific
      marker for tumor. Noninvasive visualization and quantitative analysis of integrin αvβ3
      expression provide new opportunities for tumor diagnosis, identification and efficacy
      monitoring. The peptide containing Arg-Gly-Asp (RGD) can specifically bind to integrin αvβ3
      receptor with high selectivity and affinity to achieve the detecting tumor .The SPECT/CT with
      99mTc-3PRGD2 has a high specificity in the diagnosis of mediastinal lymphnode metastasis and
      a greater value in the decision-making of lymphnode dissection.

      This study is a single-center self-controlled study, It is planned to enroll 30 patients with
      esophageal cancer , preliminarily confirmed by endoscopic biopsy, . After intravenous
      injection of 0.3 mCi/kg of 99mTC-3PRGD2, patients underwent single-photon emission computed
      tomography/computed tomography (SPECT/CT) examination.Subsequently, the patients received
      chest/abdomen enhanced CT and 18F fluorodeoxyglucose (18F-FDG) positron emission computed
      tomography /CT (PET/CT) for diagnosis. According to the determination of the researcher,
      patients who were suitable for surgery received surgery to obtain surgical pathology; For
      patients who were not suitable for surgery, ultrasound-guided lyphnode biop was performed .In
      this study, pathological specimens were obtained from gastroscopy, surgical pathology, or
      ultrasound-guided lymph node biopsy. The diagnostic accuracy, sensitivity , specificity and
      safety of SPECT/CT with 99mTc-3PRGD2 were evaluated and compared with PET-CT and enhanced CT.
Screening period All patients will be during the screening screening assessment, specific
      include: the signing of the ICF, demographic data, drug allergy history and history, height,
      weight, physical examination, vital signs, electrocardiogram (ECG) examination, laboratory
      examination, blood pregnancy test records (if applicable), endoscopic biopsy, AE and drug
      combination, check into/standard. Qualified patients will enter the administration period
      after screening and confirmation. Administration period (from Administration to safety
      follow-up) day of administration (study day 1): before administration of the experimental
      drug, 12-lead ECG, laboratory test (fasting) and vital signs were measured. Subsequently, the
      experimental drug was injected intravenously at 0.3 ± 20% mCi/kg, and subjects underwent
      urination and SPECT/CT examination 40 min after administration. AE and combined medication
      were recorded. The next day after administration (day 2 of the study): 12-lead ECG,
      laboratory examination (fasting), vital signs were measured, AE and combined medication were
      recorded. Between the administration of 99mTc-3PRGD2 and the safety follow-up, the
      investigator determined that chest/abdomen enhanced CT and PET/CT were performed at an
      optional date.

      Safety follow-up (day 14±2 of the study or before the next clinical intervention, whichever
      is shorter) :

      12 lead ECG, laboratory test (fasting), measurement of vital signs, blood pregnancy (women of
      childbearing age only), AE and combined medication were recorded.Lymph node histopathology
      was obtained by surgery in patients suitable for surgery, and by ultrasound-guided lymph node
      biopsy in patients unsuitable for surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: the accuracy of SPECT/CT with 99mTc-3PRGD2 in the diagnosis of lymph node metastasis
time frame: 14 days
description: To evaluate the accuracy of SPECT/CT with 99mTc-3PRGD2 in the diagnosis of lymph node metastasis of esophageal carcinoma，according to the pathological analysis, according to the pathological analysis.
measure: the sensitivity of SPECT/CT with 99mTc-3PRGD2 in the diagnosis of lymph node metastasis
time frame: 14 days
description: To evaluate the sensitivity of SPECT/CT with 99mTc-3PRGD2 in the diagnosis of lymph node metastasis of esophageal carcinoma，according to the pathological analysis, compared with PET-CT and enhanced CT.
measure: The Incidence of Adverse Events
time frame: 14 days
description: To evaluate the safety of 99mTc-3PRGD2 in SPECT/CT in the diagnosis of lymph node metastasis of esophageal carcinoma
arm group label: 99mTc-3PRGD2
arm group type: Experimental
description: intravenous injection of 0.3 mCi/kg of 99mTC-3PRGD2, patients underwent single-photon emission computed tomography/COMPUTED tomography (SPECT/CT) examination.
intervention type: Diagnostic Test
intervention name: 99mTc-3PRGD2
description: intravenous injection of 0.3 mCi/kg of 99mTc-3PRGD2
arm group label: 99mTc-3PRGD2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hong Shan, PhD
phone: +86-18826913336
email: shanhong@mail.sysu.edu.cn
last name: Xiaojin Wang, Master
phone: +86-13798967219
email: wangxj55@mail.sysu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
citation: Zhang Z, Zhao X, Ding C, Wang J, Zhang J, Wang F. (99m)Tc-3PRGD2 SPECT/CT Imaging for Monitoring Early Response of EGFR-TKIs Therapy in Patients with Advanced-Stage Lung Adenocarcinoma. Cancer Biother Radiopharm. 2016 Sep;31(7):238-45. doi: 10.1089/cbr.2016.2052. Epub 2016 Aug 26.
PMID: 27563805
citation: Jin X, Liang N, Wang M, Meng Y, Jia B, Shi X, Li S, Luo J, Luo Y, Cui Q, Zheng K, Liu Z, Shi J, Li F, Wang F, Zhu Z. Integrin Imaging with 99mTc-3PRGD2 SPECT/CT Shows High Specificity in the Diagnosis of Lymph Node Metastasis from Non-Small Cell Lung Cancer. Radiology. 2016 Dec;281(3):958-966. doi: 10.1148/radiol.2016150813. Epub 2016 Jul 29.
PMID: 27479638
citation: Ji B, Chen B, Wang T, Song Y, Chen M, Ji T, Wang X, Gao S, Ma Q. (9)(9)mTc-3PRGD(2) SPECT to monitor early response to neoadjuvant chemotherapy in stage II and III breast cancer. Eur J Nucl Med Mol Imaging. 2015 Aug;42(9):1362-70. doi: 10.1007/s00259-015-3062-1. Epub 2015 May 7.
PMID: 25947573
citation: Ma Q, Min K, Wang T, Chen B, Wen Q, Wang F, Ji T, Gao S. (99m)Tc-3PRGD 2 SPECT/CT predicts the outcome of advanced nonsquamous non-small cell lung cancer receiving chemoradiotherapy plus bevacizumab. Ann Nucl Med. 2015 Jul;29(6):519-27. doi: 10.1007/s12149-015-0975-5. Epub 2015 Apr 25.
PMID: 25911312
citation: Ma Q, Chen B, Gao S, Ji T, Wen Q, Song Y, Zhu L, Xu Z, Liu L. 99mTc-3P4-RGD2 scintimammography in the assessment of breast lesions: comparative study with 99mTc-MIBI. PLoS One. 2014 Sep 24;9(9):e108349. doi: 10.1371/journal.pone.0108349. eCollection 2014.
PMID: 25250628
citation: Liu L, Song Y, Gao S, Ji T, Zhang H, Ji B, Chen B, Jia B, Wang F, Xu Z, Ma Q. (99)mTc-3PRGD2 scintimammography in palpable and nonpalpable breast lesions. Mol Imaging. 2014;13(5). doi: 10.2310/7290.2014.00010.
PMID: 24825112
citation: Ma Q, Ji B, Jia B, Gao S, Ji T, Wang X, Han Z, Zhao G. Differential diagnosis of solitary pulmonary nodules using (9)(9)mTc-3P(4)-RGD(2) scintigraphy. Eur J Nucl Med Mol Imaging. 2011 Dec;38(12):2145-52. doi: 10.1007/s00259-011-1901-2. Epub 2011 Aug 27.
PMID: 21874323
citation: Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
PMID: 26808342
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
mesh term: Esophageal Neoplasms
mesh term: Lymphatic Metastasis
mesh term: Disease
sharing ipd: No