<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/NCT01698424</url>
  </required_header>
  <id_info>
    <org_study_id>PET/CT Amino Acids</org_study_id>
    <nct_id>NCT01698424</nct_id>
  </id_info>
  <brief_title>PET/CT of Skeletal Muscle Amino Acid Kinetics</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Texas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our goal is to develop and test a new imaging technique to help scientists study sarcopenia,&#xD;
      the process by which muscle becomes weaker with age. This imaging technique uses Positron&#xD;
      Emission Tomography/Computed Tomography (PET/CT) scanners to measure the ability of muscle to&#xD;
      synthesize new protein. This ability to build new muscle protein is known as the Protein&#xD;
      Synthesis Rate, and is thought to decline as people age and to contribute to muscle&#xD;
      weakening. We are researching this technique in order to develop a tool to help scientists&#xD;
      and physicians better understand how muscle ages and how it changes based on some stimulus,&#xD;
      such as when people eat a high protein meal, exercise, or take muscle-building drugs. If our&#xD;
      research is successful, it will provide a new method for scientists and physicians to test&#xD;
      the effectiveness of new drugs and other treatments for muscle weakness. The study will look&#xD;
      for healthy woman between the ages of 65 and 80.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On 2 separate visits, with approximately 2 weeks in between visits. For each visit the&#xD;
      volunteer will be required to fast overnight (no food or drink for 10 hours prior to arrival&#xD;
      at UCSF (water is OK)).&#xD;
&#xD;
      Visit 1 will last approximately 5-6 hours. Visit 2 will last approximately 8 hours. Each&#xD;
      visit will include the same general procedures, with the second visit varying slightly from&#xD;
      the first (described below). Including the 10-hour overnight fast, both visits will entail&#xD;
      roughly 15 hours of continuous fasting. After completion of Visit 1, snacks and drinks will&#xD;
      be available. For Visit 2, the volunteer will have a protein drink roughly 4-5 hours into the&#xD;
      visit, and snacks and drinks will be made available when the visit is over.&#xD;
&#xD;
      After checking in, the volunteer will be admitted to the Imaging Suite. i) Catheters At the&#xD;
      beginning of each visit, a nurse will place two flexible plastic catheters in veins in the&#xD;
      forearms. The catheters will be used to collect blood samples to measure changes in hormone&#xD;
      and amino acid levels. They will stay in place for 5 hours. One of the catheters will also be&#xD;
      used to infuse stable isotopes.&#xD;
&#xD;
      ii) Stable Isotopes Stable isotopes of amino acids are naturally occurring and are not&#xD;
      radioactive. Stable isotopes are very similar to regular amino acids, except that they are a&#xD;
      slightly heavier form (e.g., &quot;heavy water&quot; is a stable isotope of regular water). Stable&#xD;
      isotopes are already present in very small quantities in your body. For 5 hours (6am - 11am),&#xD;
      we will infuse stable isotopes into a forearm vein to increase the naturally occurring level&#xD;
      by 7-10%. We will later be able to measure this change using highly sophisticated&#xD;
      instruments. This will allow us to calculate the rate at which body builds muscle.&#xD;
&#xD;
      iii) Muscle Biopsies During each of the visits, we will have either 2 or 3 muscle biopsy&#xD;
      samples taken directly from 2 small incisions in the muscle of the thigh. On visit 1, we will&#xD;
      have biopsies at 2 time points and on visit 2 there will be 3 biopsies. The muscle biopsy&#xD;
      procedure involves the taking of a small piece of muscle tissue from the outside of the upper&#xD;
      leg, about 4-6 inches above the knee. The skin is cleaned and injected with local anesthetic&#xD;
      (lidocaine, a numbing medicine) to minimize any pain. A small incision about 1 cm will be&#xD;
      made in the skin, through which a needle about 0.8 cm is advanced into the muscle. A piece of&#xD;
      the muscle is then removed with the needle, the skin is closed with a special medical glue or&#xD;
      suture, a dressing is applied and pressure on the biopsy site held for about 10 minutes to&#xD;
      stop any bleeding that might occur. The leg is then wrapped in an ACE bandage to prevent any&#xD;
      bleeding that might occur.&#xD;
&#xD;
      iv) PET/CT Scan In between the biopsies, the volunteer will be injected into a vein with a&#xD;
      dose (12.5 millicurie) of L-[methyl-11C]methionine (11C-MET) to begin the PET/CT imaging.&#xD;
      Like the stable isotope talked about in section &quot;ii&quot; above, methionine is a naturally&#xD;
      occurring amino acid in the body. However, the form of methionine is radioactive (this allows&#xD;
      the scanner to detect its presence in your body). The PET/CT will take detailed pictures of&#xD;
      the flow of 11C-MET into the muscles of the legs, which will provide information about new&#xD;
      muscle protein being formed. The volunteer will need to lie still on a table with the thighs&#xD;
      inside the machine. The table will move and the machine will make clicking and whirring&#xD;
      noises as the pictures are taken. It will take about 90 minutes to gather the scan data.&#xD;
&#xD;
      v) Ingestion of protein drink Towards the middle of the 2nd visit, the volunteer will be&#xD;
      asked to drink approximately 8 fluid ounces of a drink that contains 15 grams of protein.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Determining skeletal muscle Protein synthesis rates, PSR</measure>
    <time_frame>12 months</time_frame>
    <description>protein synthesis rates as measured by both 11C-MET PET/CT and 13C-Phe uptake</description>
  </primary_outcome>
  <enrollment type="Actual">12</enrollment>
  <condition>Sarcopenia</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biopsies will be taken from upper thigh, Muscle tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy women&#xD;
&#xD;
          -  age 65-80 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  with any musculoskeletal disorders&#xD;
&#xD;
          -  with any metabolic disorders&#xD;
&#xD;
          -  blood thinning medications&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Lang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Imaging Center-Department of Radiology, UCSF</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>January 9, 2015</last_update_submitted>
  <last_update_submitted_qc>January 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2015</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>Sarcopenia</mesh_term>
  </condition_browse>
  <!-- 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/NCT01698424
org study id: PET/CT Amino Acids
nct id: NCT01698424
lead sponsor: 
collaborator: 
has dmc: No
Our goal is to develop and test a new imaging technique to help scientists study sarcopenia,
      the process by which muscle becomes weaker with age. This imaging technique uses Positron
      Emission Tomography/Computed Tomography (PET/CT) scanners to measure the ability of muscle to
      synthesize new protein. This ability to build new muscle protein is known as the Protein
      Synthesis Rate, and is thought to decline as people age and to contribute to muscle
      weakening. We are researching this technique in order to develop a tool to help scientists
      and physicians better understand how muscle ages and how it changes based on some stimulus,
      such as when people eat a high protein meal, exercise, or take muscle-building drugs. If our
      research is successful, it will provide a new method for scientists and physicians to test
      the effectiveness of new drugs and other treatments for muscle weakness. The study will look
      for healthy woman between the ages of 65 and 80.
On 2 separate visits, with approximately 2 weeks in between visits. For each visit the
      volunteer will be required to fast overnight (no food or drink for 10 hours prior to arrival
      at UCSF (water is OK)).

      Visit 1 will last approximately 5-6 hours. Visit 2 will last approximately 8 hours. Each
      visit will include the same general procedures, with the second visit varying slightly from
      the first (described below). Including the 10-hour overnight fast, both visits will entail
      roughly 15 hours of continuous fasting. After completion of Visit 1, snacks and drinks will
      be available. For Visit 2, the volunteer will have a protein drink roughly 4-5 hours into the
      visit, and snacks and drinks will be made available when the visit is over.

      After checking in, the volunteer will be admitted to the Imaging Suite. i) Catheters At the
      beginning of each visit, a nurse will place two flexible plastic catheters in veins in the
      forearms. The catheters will be used to collect blood samples to measure changes in hormone
      and amino acid levels. They will stay in place for 5 hours. One of the catheters will also be
      used to infuse stable isotopes.

      ii) Stable Isotopes Stable isotopes of amino acids are naturally occurring and are not
      radioactive. Stable isotopes are very similar to regular amino acids, except that they are a
      slightly heavier form (e.g., "heavy water" is a stable isotope of regular water). Stable
      isotopes are already present in very small quantities in your body. For 5 hours (6am - 11am),
      we will infuse stable isotopes into a forearm vein to increase the naturally occurring level
      by 7-10%. We will later be able to measure this change using highly sophisticated
      instruments. This will allow us to calculate the rate at which body builds muscle.

      iii) Muscle Biopsies During each of the visits, we will have either 2 or 3 muscle biopsy
      samples taken directly from 2 small incisions in the muscle of the thigh. On visit 1, we will
      have biopsies at 2 time points and on visit 2 there will be 3 biopsies. The muscle biopsy
      procedure involves the taking of a small piece of muscle tissue from the outside of the upper
      leg, about 4-6 inches above the knee. The skin is cleaned and injected with local anesthetic
      (lidocaine, a numbing medicine) to minimize any pain. A small incision about 1 cm will be
      made in the skin, through which a needle about 0.8 cm is advanced into the muscle. A piece of
      the muscle is then removed with the needle, the skin is closed with a special medical glue or
      suture, a dressing is applied and pressure on the biopsy site held for about 10 minutes to
      stop any bleeding that might occur. The leg is then wrapped in an ACE bandage to prevent any
      bleeding that might occur.

      iv) PET/CT Scan In between the biopsies, the volunteer will be injected into a vein with a
      dose (12.5 millicurie) of L-[methyl-11C]methionine (11C-MET) to begin the PET/CT imaging.
      Like the stable isotope talked about in section "ii" above, methionine is a naturally
      occurring amino acid in the body. However, the form of methionine is radioactive (this allows
      the scanner to detect its presence in your body). The PET/CT will take detailed pictures of
      the flow of 11C-MET into the muscles of the legs, which will provide information about new
      muscle protein being formed. The volunteer will need to lie still on a table with the thighs
      inside the machine. The table will move and the machine will make clicking and whirring
      noises as the pictures are taken. It will take about 90 minutes to gather the scan data.

      v) Ingestion of protein drink Towards the middle of the 2nd visit, the volunteer will be
      asked to drink approximately 8 fluid ounces of a drink that contains 15 grams of protein.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Determining skeletal muscle Protein synthesis rates, PSR
time frame: 12 months
description: protein synthesis rates as measured by both 11C-MET PET/CT and 13C-Phe uptake
Biopsies will be taken from upper thigh, Muscle tissue
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 65 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas Lang, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sarcopenia