<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/NCT02994472</url>
  </required_header>
  <id_info>
    <org_study_id>205705</org_study_id>
    <nct_id>NCT02994472</nct_id>
  </id_info>
  <brief_title>Gastric Emptying: in Vivo Studies in Healthy Volunteers</brief_title>
  <official_title>Gastric Emptying: in Vivo Studies in Healthy Volunteers (Using Scrambled Egg and Porridge) to Determine Reliable Normal Ranges</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sandwell &amp; West Birmingham Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sandwell &amp; West Birmingham Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Investigators institution has used a meal consisting of mashed potato, peas and Beanfeast&#xD;
      (soya mince) for gastric emptying studies for a number of decades. Validation of the study&#xD;
      method was purportedly performed when the study was first implemented at the hospital,&#xD;
      however no historical data has been found. The current normal ranges are also&#xD;
      unsubstantiated. There is scientific justification for this research because in vivo studies&#xD;
      are instrumental to the validation of a new procedure. There is a need for a meal preparation&#xD;
      that is palatable and meets dietary requirements (vegetarian, gluten free e.t.c.) of patients&#xD;
      as the diagnosis depends on ingestion of the radiolabelled meal. In addition, reliable normal&#xD;
      ranges will ensure that the clinical diagnosis is accurate. Scientific justification extends&#xD;
      beyond the local department as publishing the data acquired will allow other hospitals to&#xD;
      adopt the same test meals and normal ranges, leading to standardisation of the clinical&#xD;
      protocol employed across the UK. Since the investigators institution are recognised as the&#xD;
      leading Nuclear Medicine GI centre in the UK and have previously carried out audits and in&#xD;
      vitro testing in the area of gastric emptying, it seems fit that they should lead the&#xD;
      national change in protocol.&#xD;
&#xD;
      The proposed study will involve recruitment of healthy volunteers who will eat a meal&#xD;
      containing 10MBq of a radioactive tracer. They will be subsequently scanned using a gamma&#xD;
      camera with imaging lasting no more than 3 hours in total. Approximately 40 healthy&#xD;
      volunteers (18-70 years old, no history of gastrointestinal problems or other serious health&#xD;
      issues e.g. diabetes and pregnant women are excluded) will be recruited and the studies will&#xD;
      be conducted on site i.e. within the Nuclear Medicine department at City hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After the ingestion and subsequent passage of solid or liquid material into the stomach, the&#xD;
      gastric contents will undergo gastric emptying from the stomach into the intestine. The rate&#xD;
      of gastric emptying can be very variable and will depend on the presence of gastric pathology&#xD;
      or defect, composition and volume of the gastric contents and may even be influenced by&#xD;
      factors such as gender and reproductive status. Gastric motility disorders such as&#xD;
      gastroparesis and dumping syndrome can affect the rate of gastric emptying and thus warrant&#xD;
      the quantitative assessment of emptying. Gastroparesis is a disorder of the stomach&#xD;
      characterised by delayed gastric emptying in the absence of any mechanical obstruction and&#xD;
      can be further categorised based on severity; mild gastroparesis (where symptoms can be&#xD;
      easily controlled), compensated gastroparesis (partial control with use of medication and&#xD;
      dietary adjustments) and gastric failure (symptoms are not controllable). Dumping syndrome&#xD;
      occurs as a result of rapid gastric emptying which is usually associated with hypermotility&#xD;
      of the stomach. It manifests as either early or late dumping syndrome, both of which have&#xD;
      distinct physiological bases and clinical presentations.&#xD;
&#xD;
      Typical symptoms of delayed emptying include nausea, vomiting, abdominal pain and abdominal&#xD;
      fullness after eating whilst diarrhoea, weakness and light headedness after meal times are&#xD;
      common symptoms of rapid emptying. In the Nuclear Medicine department at City Hospital&#xD;
      (Birmingham), patients referred for imaging are usually diabetics suffering from feelings of&#xD;
      bloatedness after eating and occasional vomiting. Most patients studied are clinically&#xD;
      diagnosed with gastroparesis associated with diabetes (where the vagus nerve responsible for&#xD;
      controlling movement of food through the digestive tract stops functioning). Dumping is&#xD;
      rarely reported as there is an effective tablet treatment for the disorder that usually eases&#xD;
      the symptoms. (This includes octreotide therapies which can exert an effect through various&#xD;
      mechanisms such as delaying transit, inhibiting the release of gut peptides and impaired&#xD;
      fluid secretion). If left untreated gastroparesis can make diabetes worse by making it more&#xD;
      difficult to manage blood glucose. Assessment of gastric emptying rate is therefore an&#xD;
      important part of diagnosis.&#xD;
&#xD;
      Gastric emptying scintigraphy is a non-invasive diagnostic tool that is used in Nuclear&#xD;
      Medicine to study the emptying of contents into the stomach. This form of scintigraphic&#xD;
      examination is reproducible, simple to perform, accurate, quantitative and exposes the&#xD;
      patient to only a very small radiation dose. It has been significantly optimised and refined&#xD;
      over the years and is now well established as the standard method for evaluating gastric&#xD;
      emptying. As the 'gold standard' gastric emptying scintigraphy is usually the first stage of&#xD;
      the diagnostic journey for a patient, although some may have had a prior endoscopy (usually&#xD;
      in cases of severe vomiting).&#xD;
&#xD;
      The procedure is known to vary between institutions, however will usually involve binding of&#xD;
      a radiotracer to a solid or liquid meal which is then administered orally. This is followed&#xD;
      by positioning of the patient in front of a camera and continuous or intermittent imaging is&#xD;
      performed. Data is acquired over a length of time (usually 1-2 hours) and the data&#xD;
      subsequently analysed to determine the half emptying time (i.e. the time required for the&#xD;
      stomach to empty 50% of the ingested meal) which is then compared to established normal&#xD;
      ranges (i.e. normal emptying rate expected for healthy individual). The current radioactive&#xD;
      meal used for the study consisting of mashed potato, peas and Beanfeast (soya mince) is not&#xD;
      particularly palatable, does not meet the dietary requirements of some patients (e.g.&#xD;
      gluten/wheat free) and is difficult to prepare. In addition, in-house in vitro studies have&#xD;
      found the current meal to be inferior to other meal preparations. Subjecting the radioactive&#xD;
      meal to simulated conditions of the stomach has found that the radiolabel retention was&#xD;
      significantly better in other meals such as scrambled egg and porridge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2018</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>Participants subject to Gastric Emptying Scintigraphy, emptying time expressed relative to normal range.</measure>
    <time_frame>1-2 years</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Gastric Disease</condition>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each participant will have to eat scrambled egg on day 1 and porridge on day 2; both meals will contain the radioactive tracer 99mTc-DTPA.&#xD;
Participants will be scanned by a trained technologist. The scans will be carried out using a General Electric, Discovery 360 Gamma Camera.The scanning process will take approximately three hours in total, however the imaging will be carried out in stages.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Gastric emptying scintigraphy using 99mTc-DTPA</intervention_name>
    <arm_group_label>Healthy volunteers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and Female participants&#xD;
&#xD;
          -  Age range of 18-70 years old&#xD;
&#xD;
          -  All ethnicities/socio economic grouping&#xD;
&#xD;
          -  Participants living outside local area (but within UK) included (but excessive travel&#xD;
             may not be reimbursed)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Outside stated age range&#xD;
&#xD;
          -  Outside the UK&#xD;
&#xD;
          -  Have Diabetes or severe gastrointestinal symptoms such as vomiting or diarrhoea.&#xD;
&#xD;
          -  Have a gastric motility disorder&#xD;
&#xD;
          -  Pregnant women (If a participant becomes pregnant before their first test, they will&#xD;
             be withdrawn from the study, If a participant becomes pregnant between the two tests,&#xD;
             they will not be eligible for the second test but data collected from the first test&#xD;
             may still be used for analysis).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shazmeen Hansrod</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sandwell and West Birmingham Hospitals NHS Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shazmeen Hansrod</last_name>
    <phone>0121 507 4044</phone>
    <email>s.hansrod@nhs.net</email>
  </overall_contact>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sandwell &amp; West Birmingham Hospitals NHS Trust</investigator_affiliation>
    <investigator_full_name>Shazmeen Hansrod</investigator_full_name>
    <investigator_title>Clinical Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual Participant data will not be made available to other researchers.</ipd_description>
  </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/NCT02994472
org study id: 205705
nct id: NCT02994472
lead sponsor: 
has dmc: No
The Investigators institution has used a meal consisting of mashed potato, peas and Beanfeast
      (soya mince) for gastric emptying studies for a number of decades. Validation of the study
      method was purportedly performed when the study was first implemented at the hospital,
      however no historical data has been found. The current normal ranges are also
      unsubstantiated. There is scientific justification for this research because in vivo studies
      are instrumental to the validation of a new procedure. There is a need for a meal preparation
      that is palatable and meets dietary requirements (vegetarian, gluten free e.t.c.) of patients
      as the diagnosis depends on ingestion of the radiolabelled meal. In addition, reliable normal
      ranges will ensure that the clinical diagnosis is accurate. Scientific justification extends
      beyond the local department as publishing the data acquired will allow other hospitals to
      adopt the same test meals and normal ranges, leading to standardisation of the clinical
      protocol employed across the UK. Since the investigators institution are recognised as the
      leading Nuclear Medicine GI centre in the UK and have previously carried out audits and in
      vitro testing in the area of gastric emptying, it seems fit that they should lead the
      national change in protocol.

      The proposed study will involve recruitment of healthy volunteers who will eat a meal
      containing 10MBq of a radioactive tracer. They will be subsequently scanned using a gamma
      camera with imaging lasting no more than 3 hours in total. Approximately 40 healthy
      volunteers (18-70 years old, no history of gastrointestinal problems or other serious health
      issues e.g. diabetes and pregnant women are excluded) will be recruited and the studies will
      be conducted on site i.e. within the Nuclear Medicine department at City hospital.
After the ingestion and subsequent passage of solid or liquid material into the stomach, the
      gastric contents will undergo gastric emptying from the stomach into the intestine. The rate
      of gastric emptying can be very variable and will depend on the presence of gastric pathology
      or defect, composition and volume of the gastric contents and may even be influenced by
      factors such as gender and reproductive status. Gastric motility disorders such as
      gastroparesis and dumping syndrome can affect the rate of gastric emptying and thus warrant
      the quantitative assessment of emptying. Gastroparesis is a disorder of the stomach
      characterised by delayed gastric emptying in the absence of any mechanical obstruction and
      can be further categorised based on severity; mild gastroparesis (where symptoms can be
      easily controlled), compensated gastroparesis (partial control with use of medication and
      dietary adjustments) and gastric failure (symptoms are not controllable). Dumping syndrome
      occurs as a result of rapid gastric emptying which is usually associated with hypermotility
      of the stomach. It manifests as either early or late dumping syndrome, both of which have
      distinct physiological bases and clinical presentations.

      Typical symptoms of delayed emptying include nausea, vomiting, abdominal pain and abdominal
      fullness after eating whilst diarrhoea, weakness and light headedness after meal times are
      common symptoms of rapid emptying. In the Nuclear Medicine department at City Hospital
      (Birmingham), patients referred for imaging are usually diabetics suffering from feelings of
      bloatedness after eating and occasional vomiting. Most patients studied are clinically
      diagnosed with gastroparesis associated with diabetes (where the vagus nerve responsible for
      controlling movement of food through the digestive tract stops functioning). Dumping is
      rarely reported as there is an effective tablet treatment for the disorder that usually eases
      the symptoms. (This includes octreotide therapies which can exert an effect through various
      mechanisms such as delaying transit, inhibiting the release of gut peptides and impaired
      fluid secretion). If left untreated gastroparesis can make diabetes worse by making it more
      difficult to manage blood glucose. Assessment of gastric emptying rate is therefore an
      important part of diagnosis.

      Gastric emptying scintigraphy is a non-invasive diagnostic tool that is used in Nuclear
      Medicine to study the emptying of contents into the stomach. This form of scintigraphic
      examination is reproducible, simple to perform, accurate, quantitative and exposes the
      patient to only a very small radiation dose. It has been significantly optimised and refined
      over the years and is now well established as the standard method for evaluating gastric
      emptying. As the 'gold standard' gastric emptying scintigraphy is usually the first stage of
      the diagnostic journey for a patient, although some may have had a prior endoscopy (usually
      in cases of severe vomiting).

      The procedure is known to vary between institutions, however will usually involve binding of
      a radiotracer to a solid or liquid meal which is then administered orally. This is followed
      by positioning of the patient in front of a camera and continuous or intermittent imaging is
      performed. Data is acquired over a length of time (usually 1-2 hours) and the data
      subsequently analysed to determine the half emptying time (i.e. the time required for the
      stomach to empty 50% of the ingested meal) which is then compared to established normal
      ranges (i.e. normal emptying rate expected for healthy individual). The current radioactive
      meal used for the study consisting of mashed potato, peas and Beanfeast (soya mince) is not
      particularly palatable, does not meet the dietary requirements of some patients (e.g.
      gluten/wheat free) and is difficult to prepare. In addition, in-house in vitro studies have
      found the current meal to be inferior to other meal preparations. Subjecting the radioactive
      meal to simulated conditions of the stomach has found that the radiolabel retention was
      significantly better in other meals such as scrambled egg and porridge.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Participants subject to Gastric Emptying Scintigraphy, emptying time expressed relative to normal range.
time frame: 1-2 years
arm group label: Healthy volunteers
arm group type: Experimental
description: Each participant will have to eat scrambled egg on day 1 and porridge on day 2; both meals will contain the radioactive tracer 99mTc-DTPA.
Participants will be scanned by a trained technologist. The scans will be carried out using a General Electric, Discovery 360 Gamma Camera.The scanning process will take approximately three hours in total, however the imaging will be carried out in stages.
intervention type: Radiation
intervention name: Gastric emptying scintigraphy using 99mTc-DTPA
arm group label: Healthy volunteers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shazmeen Hansrod
role: Principal Investigator
affiliation: Sandwell and West Birmingham Hospitals NHS Trust
last name: Shazmeen Hansrod
phone: 0121 507 4044
email: s.hansrod@nhs.net
responsible party type: Principal Investigator
investigator affiliation: Sandwell & West Birmingham Hospitals NHS Trust
investigator full name: Shazmeen Hansrod
investigator title: Clinical Scientist
mesh term: Stomach Diseases
sharing ipd: No
ipd description: Individual Participant data will not be made available to other researchers.