<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/NCT04496089</url>
  </required_header>
  <id_info>
    <org_study_id>89Zr-TLX250-004</org_study_id>
    <nct_id>NCT04496089</nct_id>
  </id_info>
  <brief_title>Evaluation of Safety, Biodistibution and Sensitivity/Specificity of PET/CT Imaging With 89Zr-TLX250 in Subjects With RCC</brief_title>
  <acronym>ZIRDAC-JP</acronym>
  <official_title>Open-label Phase I of 89Zr-girentuximab (89Zr-TLX250) to Assess the Safety, Biodistribution, Pharmacokinetics and Sensitivity/Specificity of PET/CT Images in Patients With Suspected Renal Cell Carcinoma Including Clear Cell Renal Cell Carcinoma (ZIRDAC-JP Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Telix International Pty Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Telix International Pty Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      89Zr-TLX250 is a carbonic anydrase IX (CAIX)-targeted imaging agent that is under clinical&#xD;
      development as a non-invasive diagnostic imaging agent for teh detection of clear cell renal&#xD;
      cell carcinoma (ccRCC). The Phase 1 study part of this study is to confirm the&#xD;
      safety/tolerability and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) in&#xD;
      subjects with suspected renal cell carcinoma (RCC) including clear cell renal cell carcinoma.&#xD;
      The Phase 2 component of the study is to to evaluate the sensitivity/specificity of using&#xD;
      89Zr-TLX250 PET/CT images to detect RCC and ccRCC in patients with suspected RCC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 1:&#xD;
&#xD;
      The phase 1 component of this study will be conducted in in 6-10 subjects at one study&#xD;
      center, with the objective of confirming the safety/tolerability and the whole-body dose&#xD;
      distribution of 89Zr-TLX250. 89Zr-TLX250 will be administered via a single IV injection (at&#xD;
      least 3 min) at an activity dose of 37 MBq (± 10%) and at a dose of 10 mg (±10%). After the&#xD;
      enrollment of 6 subjects, if the male-to-female ratio is different from the Japanese&#xD;
      epidemiological RCC data (male-to-female ratio ≒ 2:1 in 2017), more subjects, up to 10&#xD;
      subjects in total, are to be enrolled.&#xD;
&#xD;
      Blood sampling for pharmacokinetic analysis will be is performed at 0.5, 1, 2, 4, 24, 72 h&#xD;
      and during the Day 5 ± 2 imaging visit. The dose distribution will be determined using&#xD;
      low-dose, non-contrast-enhanced CT whole body imaging at 0.5, 4, 24, 72 h and Day 5 ± 2.&#xD;
      Diagnostic images will be acquired on Day 3 and Day 5 ± 2 using whole body PET/CT-imaging&#xD;
      where individual organs will be assessed using Medical Internal Radiation Dose (MIRD) method.&#xD;
&#xD;
      Seven days after the Day 5 ± 2 imaging visit, patients will attend a follow-up visit to&#xD;
      conduct safety evaluations and to undergo blood sampling for HACA measurement.&#xD;
&#xD;
      Phase 2:&#xD;
&#xD;
      The phase 2 component of this study will be conducted after the completion of the phase 1&#xD;
      study in 6-10 patients. This part of the study is equivalent to a phase 2, open-label,&#xD;
      multi-center (2-5 sites) to assess the sensitivity/specificity of PET/CT images in subjects&#xD;
      with suspected but not definitely diagnosed RCC including ccRCC. The study is intended to&#xD;
      evaluate the sensitivity and specificity of PET/CT test as a non-invasive test with the&#xD;
      CAIX-targeted imaging agent 89Zr-TLX250. The study will include patients who are scheduled to&#xD;
      undergo a partial or total nephrectomy. Patients with an indeterminate renal mass with the&#xD;
      longest diameter of 7cm or less, by diagnostic imaging, will receive a single administration&#xD;
      of 37 MBq (+/- 10%) 89Zr-TLX250. Imaging will then be conducted Day 5 ± 2 post&#xD;
      administration. The partial/total nephrectomy will be performed at institutional discretion&#xD;
      any time following the PET/CT imaging visit, but no later than 90 days post administration of&#xD;
      89Zr-TLX250. Histological tumour samples will be prepared and used for histological diagnosis&#xD;
      of the renal mass (ccRCC or non-ccRCC) read by a central laboratory.&#xD;
&#xD;
      Image data analyses will be performed by a central image core lab. Qualitative visual&#xD;
      analysis (presence or absence of localised 89Zr-TLX250 uptake inside or in vicinity of renal&#xD;
      lesion, as seen on contrast-enhanced CT or MRI), will be used to assess test performance or&#xD;
      89Zr-TLX-250 PET/CT imaging to non-invasively detect ccRCC, using histological results from&#xD;
      the central histological reference laboratory as standard of truth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">April 6, 2021</completion_date>
  <primary_completion_date type="Actual">October 27, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>open-label, safety, pharmacokinetic, diagnostic, prospective, multi-center</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse events [Safety and Tolerability]</measure>
    <time_frame>90 days</time_frame>
    <description>Incidence of abnormal laboratory test results and abnormal vital signs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of the sensitivity and specificity of 89Zr-TLX250 to detect clear cell renal cell carcinoma</measure>
    <time_frame>90 days</time_frame>
    <description>The sensitivity and specificity of 89Zr-TLX250 to detect renal cell carcinoma will be established by a diagnostic scan after administration of the investigational product followed by surgery of the indeterminate mass. After surgical removal of the kidney mass , diagnostic histology of the mass will be conducted and used as the &quot;standard of truth&quot; comparator.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase 1: Evaluation of the radioactivity distribution and biodistribution/tumor uptake</measure>
    <time_frame>0.5, 4, 24, and 72 hours and Day 5 ± 2</time_frame>
    <description>Whole body PET/CT imaging (from the base of skull to the thigh) performed post-injection using non-contrast-enhanced and low-dose CT for absorption correction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1: Assessment of tumor uptake</measure>
    <time_frame>Day 3-5</time_frame>
    <description>This outcome will be evaluated by determining the absorbed dose after injection with 89Zr-TLX250 in identifiable tumor regions taking into account the tumor volume estimated from imaging performed prior to participation to the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: To evaluate positive predictive value (PPV) of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses</measure>
    <time_frame>At end of study , on average of 5 months</time_frame>
    <description>Positive predictive value (PPV) in detecting ccRCC by PT/CT imaging using 89Zr-TLX250 in subjects with undiagnosed solid renal mass</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: To evaluate negative predictive value (NPV) of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses</measure>
    <time_frame>At end of study , on average of 5 months</time_frame>
    <description>Negative predictive value (NPV) using 89Zr-TLX250 in subjects with undiagnosed solid renal mass</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate accuracy of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses</measure>
    <time_frame>At end of study , on average of 5 months</time_frame>
    <description>Determine accuracy in detecting ccRCC by PT/CT imaging using 89Zr-TLX250 in subjects with undiagnosed solid renal mass</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: To evaluate the correlation between 89Zr- girentuximab SUVs and degree of histological carbonic anhydrase IX (CAIX) expression</measure>
    <time_frame>Within 90 days</time_frame>
    <description>This outcome will be assessed on all patients. The counts derived from the PET/CT imaging of the renal lesion will be compared with the amount of CAIX expressed in the histologically extracted sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: To evaluate inter-reader variability of diagnostic assessments of 89Zr- girentuximab PET/CT images, when performed by multiple readers</measure>
    <time_frame>This analysis will be conducted through study completion, on average of 5 months</time_frame>
    <description>This outcome will be conducted on all patients. Three blinded readers operating independently will be used to read each patient PET/CT image and determine if the target lesion is positive for Zr89. A comparison of findings will then be made between the readers for each patient individually.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Assessment of differences in a same reader</measure>
    <time_frame>This analysis will be conducted through study completion, on average of 5 months</time_frame>
    <description>The difference in evaluations of 89Zr-TLX250 PET/CT images by a same reader is assessed with the use of Cohen's κ coefficient.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Carcinoma, Renal Cell</condition>
  <condition>Clear Cell Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>89Zr-girentuximab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single administration of 37 Megabecquerel (MBq) (±10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>89Zr-girentuximab</intervention_name>
    <description>A single dose of 37 MBq (±10%) is administered. The dose per dose is equivalent to girentuximab 10 mg (±10%).</description>
    <arm_group_label>89Zr-girentuximab</arm_group_label>
    <other_name>89Zr-TLX250</other_name>
    <other_name>89Zr-DFO-TFP-girentuximab (GTX)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Phase 1:&#xD;
&#xD;
          1. Written and voluntarily given informed consent&#xD;
&#xD;
          2. Aged ≥20 years at the time of enrollment&#xD;
&#xD;
          3. Suspected renal cell carcinoma who have been diagnosed with a renal mass by CT or MRI&#xD;
             performed within 90 days before screening&#xD;
&#xD;
          4. Sufficient life expectancy to participate in the study&#xD;
&#xD;
          5. Consent to practice barrier contraception (condoms) until a minimum of 42 days and 90&#xD;
             days after 89Zr-TLX250 administration in female and male, respectively&#xD;
&#xD;
        Phase 2 Part&#xD;
&#xD;
          1. Written and voluntarily given informed consent&#xD;
&#xD;
          2. Aged ≥20 years at the time of enrollment&#xD;
&#xD;
          3. Imaging evidence of a single indeterminate renal mass of ≤ 7 cm in largest diameter on&#xD;
             CT or MRI within 90 days prior to screening&#xD;
&#xD;
          4. Scheduled for lesion resection as part of regular diagnostic work-up within 90 days&#xD;
             from planned 89Zr-TLX250 administration&#xD;
&#xD;
          5. Sufficient life expectancy to undergo nephrectomy&#xD;
&#xD;
          6. Consent to practice barrier contraception (condoms) until a minimum of 42 days and 90&#xD;
             days after 89Zr-TLX250 administration in female and male, respectively&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Commonly applied for Phase 1 part and Phase 2 part&#xD;
&#xD;
          1. Those who have hypersensitivity to Girentuximab or DFO&#xD;
&#xD;
          2. Patients with metastatic renal tumor&#xD;
&#xD;
          3. Patients who need treatment for other active malignancies during the study period&#xD;
&#xD;
          4. Patients who have undergone chemotherapy, radiation therapy, or immunotherapy within 4&#xD;
             weeks before the administration of the investigational drug, or have continued adverse&#xD;
             events of grade 1 (defined in NCI-CTCAE v5.0) or higher&#xD;
&#xD;
          5. Patients scheduled for anticancer drug treatment during the period from administration&#xD;
             of investigational drug to image collection&#xD;
&#xD;
          6. Patients who have been exposed to mouse or chimeric antibody within the past 5 years&#xD;
&#xD;
          7. Patients who have been administered some kind of radionuclide earlier than 10&#xD;
             half-lives of the nuclide.&#xD;
&#xD;
          8. Patients with severe, but not fatal disease, for which the principal investigator /&#xD;
             investigator has determined that study participation is not appropriate&#xD;
&#xD;
          9. Women who are pregnant or breastfeeding. And women with childbearing potential who are&#xD;
             not pregnant or breastfeeding but suspected of being pregnant by the blood test at&#xD;
             screening and pre-dose (within 24 hours before administration). Pre-dose blood&#xD;
             pregnancy test can be replaced with urine test&#xD;
&#xD;
         10. Patients who have been administered the drug by any clinical study or clinical trial&#xD;
             within 30 days before the scheduled administration of the investigational drug&#xD;
&#xD;
         11. Patients who cannot give legally valid consent by himself / herself&#xD;
&#xD;
         12. Patients with renal dysfunction whose GFR is 60mL / min / 1.73m2 or less&#xD;
&#xD;
         13. Patents who are socially vulnerable (e.g., patients in custody)&#xD;
&#xD;
         14. Others who are judged by the principal investigator or investigator to be&#xD;
             inappropriate for participation in this trial Applied only to Phase 2 part 15．&#xD;
             Patients whose biopsy is more suitable for pathological diagnosis than partial&#xD;
             resection or nephrectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noboru Nakaigawa, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yokohama City University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yokohama City University Hospital</name>
      <address>
        <city>Yokohama City</city>
        <state>Kanagawa</state>
        <zip>236-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>August 18, 2021</last_update_submitted>
  <last_update_submitted_qc>August 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>clear cell renal cell carcinoma</keyword>
  <keyword>PET/CT imaging</keyword>
  <keyword>89Zr-girentuximab</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>pharmacodynamics</keyword>
  <keyword>safety</keyword>
  <keyword>Diagnostic imaging</keyword>
  <keyword>89Zr-TLX250</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</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/NCT04496089
org study id: 89Zr-TLX250-004
nct id: NCT04496089
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
89Zr-TLX250 is a carbonic anydrase IX (CAIX)-targeted imaging agent that is under clinical
      development as a non-invasive diagnostic imaging agent for teh detection of clear cell renal
      cell carcinoma (ccRCC). The Phase 1 study part of this study is to confirm the
      safety/tolerability and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) in
      subjects with suspected renal cell carcinoma (RCC) including clear cell renal cell carcinoma.
      The Phase 2 component of the study is to to evaluate the sensitivity/specificity of using
      89Zr-TLX250 PET/CT images to detect RCC and ccRCC in patients with suspected RCC.
Phase 1:

      The phase 1 component of this study will be conducted in in 6-10 subjects at one study
      center, with the objective of confirming the safety/tolerability and the whole-body dose
      distribution of 89Zr-TLX250. 89Zr-TLX250 will be administered via a single IV injection (at
      least 3 min) at an activity dose of 37 MBq (± 10%) and at a dose of 10 mg (±10%). After the
      enrollment of 6 subjects, if the male-to-female ratio is different from the Japanese
      epidemiological RCC data (male-to-female ratio ≒ 2:1 in 2017), more subjects, up to 10
      subjects in total, are to be enrolled.

      Blood sampling for pharmacokinetic analysis will be is performed at 0.5, 1, 2, 4, 24, 72 h
      and during the Day 5 ± 2 imaging visit. The dose distribution will be determined using
      low-dose, non-contrast-enhanced CT whole body imaging at 0.5, 4, 24, 72 h and Day 5 ± 2.
      Diagnostic images will be acquired on Day 3 and Day 5 ± 2 using whole body PET/CT-imaging
      where individual organs will be assessed using Medical Internal Radiation Dose (MIRD) method.

      Seven days after the Day 5 ± 2 imaging visit, patients will attend a follow-up visit to
      conduct safety evaluations and to undergo blood sampling for HACA measurement.

      Phase 2:

      The phase 2 component of this study will be conducted after the completion of the phase 1
      study in 6-10 patients. This part of the study is equivalent to a phase 2, open-label,
      multi-center (2-5 sites) to assess the sensitivity/specificity of PET/CT images in subjects
      with suspected but not definitely diagnosed RCC including ccRCC. The study is intended to
      evaluate the sensitivity and specificity of PET/CT test as a non-invasive test with the
      CAIX-targeted imaging agent 89Zr-TLX250. The study will include patients who are scheduled to
      undergo a partial or total nephrectomy. Patients with an indeterminate renal mass with the
      longest diameter of 7cm or less, by diagnostic imaging, will receive a single administration
      of 37 MBq (+/- 10%) 89Zr-TLX250. Imaging will then be conducted Day 5 ± 2 post
      administration. The partial/total nephrectomy will be performed at institutional discretion
      any time following the PET/CT imaging visit, but no later than 90 days post administration of
      89Zr-TLX250. Histological tumour samples will be prepared and used for histological diagnosis
      of the renal mass (ccRCC or non-ccRCC) read by a central laboratory.

      Image data analyses will be performed by a central image core lab. Qualitative visual
      analysis (presence or absence of localised 89Zr-TLX250 uptake inside or in vicinity of renal
      lesion, as seen on contrast-enhanced CT or MRI), will be used to assess test performance or
      89Zr-TLX-250 PET/CT imaging to non-invasively detect ccRCC, using histological results from
      the central histological reference laboratory as standard of truth.
allocation: N/A
intervention model: Sequential Assignment
intervention model description: open-label, safety, pharmacokinetic, diagnostic, prospective, multi-center
primary purpose: Health Services Research
masking: None (Open Label)
measure: Incidence of Treatment-Emergent Adverse events [Safety and Tolerability]
time frame: 90 days
description: Incidence of abnormal laboratory test results and abnormal vital signs
measure: Determination of the sensitivity and specificity of 89Zr-TLX250 to detect clear cell renal cell carcinoma
time frame: 90 days
description: The sensitivity and specificity of 89Zr-TLX250 to detect renal cell carcinoma will be established by a diagnostic scan after administration of the investigational product followed by surgery of the indeterminate mass. After surgical removal of the kidney mass , diagnostic histology of the mass will be conducted and used as the "standard of truth" comparator.
measure: Phase 1: Evaluation of the radioactivity distribution and biodistribution/tumor uptake
time frame: 0.5, 4, 24, and 72 hours and Day 5 ± 2
description: Whole body PET/CT imaging (from the base of skull to the thigh) performed post-injection using non-contrast-enhanced and low-dose CT for absorption correction.
measure: Phase 1: Assessment of tumor uptake
time frame: Day 3-5
description: This outcome will be evaluated by determining the absorbed dose after injection with 89Zr-TLX250 in identifiable tumor regions taking into account the tumor volume estimated from imaging performed prior to participation to the study.
measure: Phase 2: To evaluate positive predictive value (PPV) of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses
time frame: At end of study , on average of 5 months
description: Positive predictive value (PPV) in detecting ccRCC by PT/CT imaging using 89Zr-TLX250 in subjects with undiagnosed solid renal mass
measure: Phase 2: To evaluate negative predictive value (NPV) of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses
time frame: At end of study , on average of 5 months
description: Negative predictive value (NPV) using 89Zr-TLX250 in subjects with undiagnosed solid renal mass
measure: To evaluate accuracy of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses
time frame: At end of study , on average of 5 months
description: Determine accuracy in detecting ccRCC by PT/CT imaging using 89Zr-TLX250 in subjects with undiagnosed solid renal mass
measure: Phase 2: To evaluate the correlation between 89Zr- girentuximab SUVs and degree of histological carbonic anhydrase IX (CAIX) expression
time frame: Within 90 days
description: This outcome will be assessed on all patients. The counts derived from the PET/CT imaging of the renal lesion will be compared with the amount of CAIX expressed in the histologically extracted sample
measure: Phase 2: To evaluate inter-reader variability of diagnostic assessments of 89Zr- girentuximab PET/CT images, when performed by multiple readers
time frame: This analysis will be conducted through study completion, on average of 5 months
description: This outcome will be conducted on all patients. Three blinded readers operating independently will be used to read each patient PET/CT image and determine if the target lesion is positive for Zr89. A comparison of findings will then be made between the readers for each patient individually.
measure: Phase 2: Assessment of differences in a same reader
time frame: This analysis will be conducted through study completion, on average of 5 months
description: The difference in evaluations of 89Zr-TLX250 PET/CT images by a same reader is assessed with the use of Cohen's κ coefficient.
arm group label: 89Zr-girentuximab
arm group type: Experimental
description: A single administration of 37 Megabecquerel (MBq) (±10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab
intervention type: Diagnostic Test
intervention name: 89Zr-girentuximab
description: A single dose of 37 MBq (±10%) is administered. The dose per dose is equivalent to girentuximab 10 mg (±10%).
arm group label: 89Zr-girentuximab
other name: 89Zr-TLX250
other name: 89Zr-DFO-TFP-girentuximab (GTX)
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Noboru Nakaigawa, MD, PhD
role: Principal Investigator
affiliation: Yokohama City University Hospital
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
sharing ipd: No