<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/NCT04480619</url>
  </required_header>
  <id_info>
    <org_study_id>145314</org_study_id>
    <nct_id>NCT04480619</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Ga68 Αvβ3 IAC PET/CT for Diagnosis and Clinical Management in Angiogenic Breast Cancer Patients</brief_title>
  <acronym>Shiva</acronym>
  <official_title>Safety and Efficacy of Ga-68-Αvβ3 IAC Positron Emission Tomography (PET/CT) for Diagnosis and Clinical Management in Angiogenic Breast Cancer Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Advanced Imaging Projects, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>All India Institute of Medical Sciences, New Delhi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Post Graduate Institute of Medical Education and Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Witwatersrand, South Africa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>US Department of Veterans Affairs</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Advanced Imaging Projects, LLC</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a phase I/IIa, open label, multicenter interventional study of Gallium-68&#xD;
      radiolabeled PEG-αvβ3-Integrin Adhesion Complex antagonist conjugate (Ga-68-PEG-Αvβ3-IAC)&#xD;
      Positron Emission Tomography (PET/CT) imaging, intended for diagnosis, and clinical&#xD;
      management of patients with angiogenic breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective non blinded trial, Phase I/IIa, multicenter, study in a total of up to&#xD;
      25 subjects with angiogenic therapy indication for breast cancer. All patients with confirmed&#xD;
      diagnoses will undergo [18F]Fluoro-deoxyglucose (18F-FDG) PET/CT (6-12 mCi) and&#xD;
      Ga-68-PEG-αvβ3 IAC PET/CT 2-5 mCi to evaluate safety, biodistribution, and response to&#xD;
      treatment in angiogenic breast cancer patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">August 30, 2022</start_date>
  <completion_date type="Anticipated">August 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Ga-68 PEG-Αvβ3-IAC PET/CT</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Specific Aims 1:To evaluate the safety, toxicity profile and tolerability of Ga-68-PEG-αvβ3-IAC in patients diagnosed with angiogenic breast cancer.</measure>
    <time_frame>6 Months</time_frame>
    <description>Assess drug safety and tolerability measuring Incidence of adverse events. NCI Common Terminology Criteria for Adverse Events v5.0, where: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specific Aims 2:To evaluate biodistribution and dosimetry of Ga-68-PEG-αvβ3-IAC</measure>
    <time_frame>6 Months</time_frame>
    <description>Assess drug safety and tolerability measuring incidence of abnormal vital signs. Vital signs will include measurements of respiratory rate, pulse rate, and systolic and diastolic blood pressure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specific Aims 3: To determine the recommended phase 2 dose (RP2D) of Ga-68-PEG-αvβ3-IAC examination</measure>
    <time_frame>6 Months</time_frame>
    <description>Assess drug safety and tolerability measuring incidence of abnormal physical examination findings. Physical examination will be summarized for each body system such as head, eyes, ears, nose, and throat, and cardiovascular, dermatological, musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurological systems.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specific Aim 1: To determine the pharmacokinetic and pharmacodynamic profile of Ga-68-PEG-αvβ3-IAC</measure>
    <time_frame>6 Months</time_frame>
    <description>Assess drug uptake using median and maximum standardized uptake values (SUV).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Diagnosis and Clinical Management of Angiogenic Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Ga-68-PEG-Αvβ3-IAC PET/CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Companion Ga-68 PET diagnostic for tumor targeted therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ga-68-PEG-Αvβ3-IAC PET/CT</intervention_name>
    <description>PET Diagnostic Agent</description>
    <arm_group_label>Ga-68-PEG-Αvβ3-IAC PET/CT</arm_group_label>
    <other_name>Ga-68Αvβ3-IAC PET/CT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with solid tumors (either 3+ by immunohistochemistry or with evidence of gene&#xD;
             amplification (&gt;2.0) by fluorescence in situ hybridization (FISH))&#xD;
&#xD;
               -  At least 18 years of age&#xD;
&#xD;
               -  Able to provide informed consent.&#xD;
&#xD;
        Karnofsky score greater than 50&#xD;
&#xD;
          -  Females of childbearing potential must have a negative pregnancy test at&#xD;
             screening/baseline&#xD;
&#xD;
          -  AIP-301 Ga-68 positive scan define by SUV greater than 10.&#xD;
&#xD;
          -  Adequate organ function, defined as:&#xD;
&#xD;
               1. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.&#xD;
&#xD;
               2. Hemoglobin (Hb) ≥9 g/dl (transfusion or use of EPO is permitted).&#xD;
&#xD;
               3. Platelets &gt; 100,000/mm3&#xD;
&#xD;
               4. Creatinine ≤ 1.5 x normal value based on the Cock Gault (CG) equation.&#xD;
&#xD;
               5. AST or ALT ≤ 2.5 x ULN (or ≤5 x ULN in case of liver metastasis)&#xD;
&#xD;
               6. Alkaline phosphatase ≤2.5 x ULN. Alkaline phosphatase may be more than 2.5 x ULN&#xD;
                  only in the case of bone metastases, and AST and ALT less than 1.5 x ULN.&#xD;
&#xD;
               7. Total bilirubin ≤1.5 mg/dl (higher bilirubin levels are permitted if the patient&#xD;
                  has Gilbert's syndrome).&#xD;
&#xD;
        Baseline LVEF ≥50% measured using echocardiogram or equilibrium&#xD;
&#xD;
        isotopic ventriculography (MUGA).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Serum creatinine &gt;3.0 mg/dL (270 μM/L)&#xD;
&#xD;
               -  Hepatic enzyme levels more than 5 times upper limit of normal.&#xD;
&#xD;
               -  Known severe allergy or hypersensitivity to IV radiographic contrast.&#xD;
&#xD;
               -  Use of any other investigational product or device within 30 days prior to dosing&#xD;
                  or known requirement for any other investigational agent prior to completion of&#xD;
                  all scheduled study assessments.&#xD;
&#xD;
               -  Patients with a body weight of 400 pounds or more or not able to enter the bore&#xD;
                  of the PET/CT scanner due to BMI, because of the compromise in image quality with&#xD;
                  CT, PET/CT and MRI that will result.&#xD;
&#xD;
               -  Inability to lie still for the entire imaging time (e.g. cough, severe arthritis,&#xD;
                  etc.).&#xD;
&#xD;
               -  Inability to complete the needed investigational and standard-of-care imaging&#xD;
                  examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)&#xD;
&#xD;
               -  Recognized concurrent active infection (e.g., HIV)&#xD;
&#xD;
               -  Previous Grade 3 or higher allergic reaction to Trastuzumab that resulted in&#xD;
                  discontinuation of Trastuzumab therapy. Any additional medical condition, serious&#xD;
                  intercurrent illness, or other extenuating circumstance that, in the opinion of&#xD;
                  the Investigator, may significantly interfere with study compliance.&#xD;
&#xD;
                    -  Adult patients who require monitored anesthesia for PET scanning&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Stanley Satz, Ph.D.</last_name>
    <phone>561-561 286-6842</phone>
    <email>ssatz@advancedimagingprojects.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rose Satz</last_name>
    <phone>5617578666</phone>
    <email>rsatz@advancedimagingprojects.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Postgraduate Institute of Medical and Research</name>
      <address>
        <city>Chandigarh</city>
        <country>India</country>
      </address>
    </facility>
    <contact>
      <last_name>B.R. Mittal, M.D./Ph.D.</last_name>
      <email>brmittal@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>All India Institute of Medical Sciences</name>
      <address>
        <city>New Delhi</city>
        <country>India</country>
      </address>
    </facility>
    <contact>
      <last_name>C.S. Ball</last_name>
      <phone>01126546477</phone>
      <email>drcsbal@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Witwatersrand</name>
      <address>
        <city>Johannesburg</city>
        <country>South Africa</country>
      </address>
    </facility>
    <contact>
      <last_name>Mboyo Vangu, M.D./Ph.D.</last_name>
      <phone>0832670004</phone>
      <email>Mboyo-Di-Tamba.Vangu@wits.ac.za</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
    <country>South Africa</country>
  </location_countries>
  <results_reference>
    <citation>Baum RP, Kulkarni HR, Muller D, Satz S, Danthi N, Kim YS, Brechbiel MW. First-In-Human Study Demonstrating Tumor-Angiogenesis by PET/CT Imaging with (68)Ga-NODAGA-THERANOST, a High-Affinity Peptidomimetic for alphavbeta3 Integrin Receptor Targeting. Cancer Biother Radiopharm. 2015 May;30(4):152-9. doi: 10.1089/cbr.2014.1747.</citation>
    <PMID>25945808</PMID>
  </results_reference>
  <results_reference>
    <citation>Kim YS, Nwe K, Milenic DE, Brechbiel MW, Satz S, Baidoo KE. Synthesis and characterization of alphavbeta(3)-targeting peptidomimetic chelate conjugates for PET and SPECT imaging. Bioorg Med Chem Lett. 2012 Sep 1;22(17):5517-22. doi: 10.1016/j.bmcl.2012.07.024. Epub 2012 Jul 14.</citation>
    <PMID>22853992</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>May 27, 2022</last_update_submitted>
  <last_update_submitted_qc>May 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2022</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>Breast Neoplasms</mesh_term>
    <mesh_term>Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be available after completion of clinical trial</ipd_description>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>2 years</ipd_time_frame>
  </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/NCT04480619
org study id: 145314
nct id: NCT04480619
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a phase I/IIa, open label, multicenter interventional study of Gallium-68
      radiolabeled PEG-αvβ3-Integrin Adhesion Complex antagonist conjugate (Ga-68-PEG-Αvβ3-IAC)
      Positron Emission Tomography (PET/CT) imaging, intended for diagnosis, and clinical
      management of patients with angiogenic breast cancer.
This is a prospective non blinded trial, Phase I/IIa, multicenter, study in a total of up to
      25 subjects with angiogenic therapy indication for breast cancer. All patients with confirmed
      diagnoses will undergo [18F]Fluoro-deoxyglucose (18F-FDG) PET/CT (6-12 mCi) and
      Ga-68-PEG-αvβ3 IAC PET/CT 2-5 mCi to evaluate safety, biodistribution, and response to
      treatment in angiogenic breast cancer patients.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Ga-68 PEG-Αvβ3-IAC PET/CT
primary purpose: Diagnostic
masking: None (Open Label)
measure: Specific Aims 1:To evaluate the safety, toxicity profile and tolerability of Ga-68-PEG-αvβ3-IAC in patients diagnosed with angiogenic breast cancer.
time frame: 6 Months
description: Assess drug safety and tolerability measuring Incidence of adverse events. NCI Common Terminology Criteria for Adverse Events v5.0, where: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening
measure: Specific Aims 2:To evaluate biodistribution and dosimetry of Ga-68-PEG-αvβ3-IAC
time frame: 6 Months
description: Assess drug safety and tolerability measuring incidence of abnormal vital signs. Vital signs will include measurements of respiratory rate, pulse rate, and systolic and diastolic blood pressure.
measure: Specific Aims 3: To determine the recommended phase 2 dose (RP2D) of Ga-68-PEG-αvβ3-IAC examination
time frame: 6 Months
description: Assess drug safety and tolerability measuring incidence of abnormal physical examination findings. Physical examination will be summarized for each body system such as head, eyes, ears, nose, and throat, and cardiovascular, dermatological, musculoskeletal, respiratory, gastrointestinal, genitourinary, and neurological systems.
measure: Specific Aim 1: To determine the pharmacokinetic and pharmacodynamic profile of Ga-68-PEG-αvβ3-IAC
time frame: 6 Months
description: Assess drug uptake using median and maximum standardized uptake values (SUV).
arm group label: Ga-68-PEG-Αvβ3-IAC PET/CT
arm group type: Experimental
description: Companion Ga-68 PET diagnostic for tumor targeted therapy
intervention type: Diagnostic Test
intervention name: Ga-68-PEG-Αvβ3-IAC PET/CT
description: PET Diagnostic Agent
arm group label: Ga-68-PEG-Αvβ3-IAC PET/CT
other name: Ga-68Αvβ3-IAC PET/CT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Stanley Satz, Ph.D.
phone: 561-561 286-6842
email: ssatz@advancedimagingprojects.com
last name: Rose Satz
phone: 5617578666
email: rsatz@advancedimagingprojects.com
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
country: India
country: South Africa
citation: Baum RP, Kulkarni HR, Muller D, Satz S, Danthi N, Kim YS, Brechbiel MW. First-In-Human Study Demonstrating Tumor-Angiogenesis by PET/CT Imaging with (68)Ga-NODAGA-THERANOST, a High-Affinity Peptidomimetic for alphavbeta3 Integrin Receptor Targeting. Cancer Biother Radiopharm. 2015 May;30(4):152-9. doi: 10.1089/cbr.2014.1747.
PMID: 25945808
citation: Kim YS, Nwe K, Milenic DE, Brechbiel MW, Satz S, Baidoo KE. Synthesis and characterization of alphavbeta(3)-targeting peptidomimetic chelate conjugates for PET and SPECT imaging. Bioorg Med Chem Lett. 2012 Sep 1;22(17):5517-22. doi: 10.1016/j.bmcl.2012.07.024. Epub 2012 Jul 14.
PMID: 22853992
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Disease
sharing ipd: Yes
ipd description: Data will be available after completion of clinical trial
ipd info type: Clinical Study Report (CSR)
ipd time frame: 2 years