xml: <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/NCT06016075</url>
    </required_header>
    <id_info>
      <org_study_id>Radiology, Uni of Cambridge</org_study_id>
      <secondary_id>22/EE/0136</secondary_id>
      <secondary_id>314155</secondary_id>
      <nct_id>NCT06016075</nct_id>
    </id_info>
    <brief_title>Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques</brief_title>
    <acronym>IBM-Renal</acronym>
    <official_title>Investigation of Differential Biology of Benign and Malignant Renal Masses Using Advanced Magnetic Resonance Imaging Techniques</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Cambridge</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Cambridge</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to develop techniques for non-invasive imaging of biology in&#xD;
        participants with benign or malignant renal masses based on the novel scanning MRI&#xD;
        techniques, including recently invented Hyperpolarised MRI, deuterium metabolic imaging and&#xD;
        sodium MRI. This imaging study will: 1) acquire imaging data from human tissues following the&#xD;
        injection of hyperpolarised 13C pyruvate and use 13C-MRI to monitor changes in the ratio of&#xD;
        13C-lactate to 13C-pyruvate; 2) acquire imaging data from human tissues using Sodium MRI or&#xD;
        3) acquire imaging data from human tissues following the oral consumable of deuterated&#xD;
        glucose. Data acquired during this physiological study will be used to optimise future&#xD;
        imaging protocols.In the UK and possibly in other countries, there are some patients with&#xD;
        renal masses that are over treated or undergo unnecessary procedures such as surgery or&#xD;
        biopsies, as they are thought to have a malignant tumour or a more aggressive tumour but&#xD;
        after the procedure it is found that the mass was benign. The aim of this study is to&#xD;
        determine whether one or all of these imaging techniques can differentiate between benign and&#xD;
        malignant renal masses with the view to developing the techniques further and hopefully&#xD;
        reducing the need for over treatment or unnecessary procedures in patients with benign&#xD;
        masses.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>LAC/PYR ratio</measure>
      <time_frame>1 year</time_frame>
      <description>LAC/PYR ratio in renal tumours, which is a quantitative measure of conversion from pyruvate to lactate in the tissue of interest.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Total Sodium Concentration</measure>
      <time_frame>1 year</time_frame>
      <description>Total Sodium Concentration - in renal tumours</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Technical development of DMI in the abdomen</measure>
      <time_frame>1 year</time_frame>
      <description>Detection of metabolites within the DMI spectrum in the abdomen is limited by large lipid peaks and variability of tissues. Therefore, this work will aim to improve acquisition and processing methods to develop abdominal DMI with the hope to evaluate lactate across renal tumour subtypes.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Kidney Cancer</condition>
    <arm_group>
      <arm_group_label>Hyperpolarised MRI</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sodium MRI</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>MRI procedure as a regular MRI scan, the only change is us using a different sort of equipment so we are able to detect sodium.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Deuterium metabolic imaging (DMI) MRI</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Hyperpolarised MRI</intervention_name>
      <description>Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.</description>
      <arm_group_label>Hyperpolarised MRI</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sodium MRI</intervention_name>
      <description>MRI procedure as a regular MRI scan, the only change is us using a different sort of equipment so we are able to detect sodium.</description>
      <arm_group_label>Sodium MRI</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Deuterium metabolic imaging (DMI) MRI</intervention_name>
      <description>Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.</description>
      <arm_group_label>Deuterium metabolic imaging (DMI) MRI</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Over 18 years old&#xD;
  &#xD;
            -  Able to and provide written informed consent to participate&#xD;
  &#xD;
            -  If female, postmenopausal or if women of child bearing potential (WOCBP) using a&#xD;
               suitable contraception&#xD;
  &#xD;
            -  If male, using a suitable contraceptive method for the duration of the study&#xD;
  &#xD;
            -  Radiologically suspected or pathologically confirmed benign or malignant renal masses,&#xD;
               as determined by standard clinical practice&#xD;
  &#xD;
            -  Capable of undergoing a minimum of one study visit&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Contraindication or inability to tolerate MRI&#xD;
  &#xD;
            -  Pregnant or actively breast-feeding woman&#xD;
  &#xD;
            -  If using an intrauterine contraceptive device (IUCD) as a method of contraception the&#xD;
               device should be MRI safe at 3 T (researcher to confirm)&#xD;
  &#xD;
            -  Clinically significant cardiac, pulmonary or neurological diseases as determined by&#xD;
               the investigators&#xD;
  &#xD;
            -  Laboratory abnormalities that may impact on the study results&#xD;
  &#xD;
            -  Any other significant medical or psychiatric history rendering the subject ineligible&#xD;
               as deemed by the investigators&#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_official>
      <last_name>Ferdia A Gallagher, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Principal Investigator</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ines Horvat-Menih, MD</last_name>
      <phone>+44 1223 767062</phone>
      <email>ih357@cam.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Marta Wylot, PhD</last_name>
      <phone>+44 1223 767062</phone>
      <email>mw699@medschl.cam.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Department of Radiology</name>
        <address>
          <city>Cambridge</city>
          <state>Cambridgeshire</state>
          <zip>CB2 0QQ</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ines Horvat-Menih, MD</last_name>
        <phone>+44 1223 767062</phone>
        <email>ih357@cam.ac.uk</email>
      </contact>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Cambridge</investigator_affiliation>
      <investigator_full_name>Ines Horvat-Menih</investigator_full_name>
      <investigator_title>Doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016075
  org study id: Radiology, Uni of Cambridge
  secondary id: 22/EE/0136
  secondary id: 314155
  nct id: NCT06016075
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to develop techniques for non-invasive imaging of biology in
        participants with benign or malignant renal masses based on the novel scanning MRI
        techniques, including recently invented Hyperpolarised MRI, deuterium metabolic imaging and
        sodium MRI. This imaging study will: 1) acquire imaging data from human tissues following the
        injection of hyperpolarised 13C pyruvate and use 13C-MRI to monitor changes in the ratio of
        13C-lactate to 13C-pyruvate; 2) acquire imaging data from human tissues using Sodium MRI or
        3) acquire imaging data from human tissues following the oral consumable of deuterated
        glucose. Data acquired during this physiological study will be used to optimise future
        imaging protocols.In the UK and possibly in other countries, there are some patients with
        renal masses that are over treated or undergo unnecessary procedures such as surgery or
        biopsies, as they are thought to have a malignant tumour or a more aggressive tumour but
        after the procedure it is found that the mass was benign. The aim of this study is to
        determine whether one or all of these imaging techniques can differentiate between benign and
        malignant renal masses with the view to developing the techniques further and hopefully
        reducing the need for over treatment or unnecessary procedures in patients with benign
        masses.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: LAC/PYR ratio
  time frame: 1 year
  description: LAC/PYR ratio in renal tumours, which is a quantitative measure of conversion from pyruvate to lactate in the tissue of interest.
  measure: Total Sodium Concentration
  time frame: 1 year
  description: Total Sodium Concentration - in renal tumours
  measure: Technical development of DMI in the abdomen
  time frame: 1 year
  description: Detection of metabolites within the DMI spectrum in the abdomen is limited by large lipid peaks and variability of tissues. Therefore, this work will aim to improve acquisition and processing methods to develop abdominal DMI with the hope to evaluate lactate across renal tumour subtypes.
  arm group label: Hyperpolarised MRI
  arm group type: Other
  description: Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.
  arm group label: Sodium MRI
  arm group type: Other
  description: MRI procedure as a regular MRI scan, the only change is us using a different sort of equipment so we are able to detect sodium.
  arm group label: Deuterium metabolic imaging (DMI) MRI
  arm group type: Other
  description: Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.
  intervention type: Device
  intervention name: Hyperpolarised MRI
  description: Hyperpolarised 13C-pyruvate injection while laying in the MRI scanner. Non-radioactive, no risk, approved for use in humans.
  arm group label: Hyperpolarised MRI
  intervention type: Device
  intervention name: Sodium MRI
  description: MRI procedure as a regular MRI scan, the only change is us using a different sort of equipment so we are able to detect sodium.
  arm group label: Sodium MRI
  intervention type: Device
  intervention name: Deuterium metabolic imaging (DMI) MRI
  description: Drink of a sugar drink 90min before the MRI scan. Non-radioactive, no risk, approved for use in humans.
  arm group label: Deuterium metabolic imaging (DMI) MRI
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ferdia A Gallagher, MD PhD
  role: Principal Investigator
  affiliation: Principal Investigator
  last name: Ines Horvat-Menih, MD
  phone: +44 1223 767062
  email: ih357@cam.ac.uk
  last name: Marta Wylot, PhD
  phone: +44 1223 767062
  email: mw699@medschl.cam.ac.uk
  facility: 
  status: Recruiting
  contact: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: University of Cambridge
  investigator full name: Ines Horvat-Menih
  investigator title: Doctor
  mesh term: Kidney Neoplasms
  sharing ipd: Undecided