Gastric DiseaseNCT02994472
Gastric Emptying: in Vivo Studies in Healthy Volunteers
A study testing Gastric emptying scintigraphy using 99mTc-DTPA in people with Gastric Disease, run by Sandwell & West Birmingham Hospitals NHS Trust.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Disease
- What is being tested?
- Gastric emptying scintigraphy using 99mTc-DTPA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and Female participants
- Age range of 18-70 years old
- All ethnicities/socio economic grouping
- Participants living outside local area (but within UK) included (but excessive travel may not be reimbursed)
Who cannot join
- Outside stated age range
- Outside the UK
- Have Diabetes or severe gastrointestinal symptoms such as vomiting or diarrhoea.
- Have a gastric motility disorder
- Pregnant women (If a participant becomes pregnant before their first test, they will be withdrawn from the study, If a participant becomes pregnant between the two tests, they will not be eligible for the second test but data collected from the first test may still be used for analysis).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Gastric Emptying: in Vivo Studies in Healthy Volunteers (Using Scrambled Egg and Porridge) to Determine Reliable Normal Ranges
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.
Read the detailed description
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.
- Conditions
- Gastric Disease
- Being tested
- Gastric emptying scintigraphy using 99mTc-DTPA
- Medical subject headings
- Stomach Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric emptying scintigraphy using 99mTc-DTPARadiation
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | 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. Receives: Radiation: Gastric emptying scintigraphy using 99mTc-DTPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants subject to Gastric Emptying Scintigraphy, emptying time expressed relative to normal range.
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shazmeen Hansrod, Sandwell & West Birmingham Hospitals NHS Trust
- Investigators
- Shazmeen Hansrod, Principal investigator, Sandwell and West Birmingham Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994472
- Sponsor's protocol ID
- 205705
- Status last verified
- Dec 2016
- First submitted
- 8 Dec 2016
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual Participant data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Emptying: in Vivo Studies in Healthy Volunteers (Using Scrambled Egg and Porridge) to Determine Reliable Normal Ranges
- ClinicalTrials.gov ID
- NCT02994472
- Acronym / sponsor ID
- 205705
- Conditions
- Gastric Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS TrustUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Radiation: Gastric emptying scintigraphy using 99mTc-DTPAEach 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and Female participants
- Age range of 18-70 years old
- All ethnicities/socio economic grouping
- Participants living outside local area (but within UK) included (but excessive travel may not be reimbursed)
Key exclusion criteria (5 listed)
- Outside stated age range
- Outside the UK
- Have Diabetes or severe gastrointestinal symptoms such as vomiting or diarrhoea.
- Have a gastric motility disorder
- Pregnant women (If a participant becomes pregnant before their first test, they will be withdrawn from the study, If a participant becomes pregnant between the two tests, they will not be eligible for the second test but data collected from the first test may still be used for analysis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric emptying scintigraphy using 99mTc-DTPA | Radiation | Healthy volunteers |
Primary outcome
Participants subject to Gastric Emptying Scintigraphy, emptying time expressed relative to normal range.
Time frame: 1-2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
- Individual participant dataSharing planned: No. Individual Participant data will not be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shazmeen Hansrod principal investigator
Sandwell and West Birmingham Hospitals NHS Trust
Questions about this trial
What is this clinical trial studying?
A study testing Gastric emptying scintigraphy using 99mTc-DTPA in people with Gastric Disease, run by Sandwell & West Birmingham Hospitals NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shazmeen Hansrod (0121 507 4044, s.hansrod@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants subject to Gastric Emptying Scintigraphy, emptying time expressed relative to normal range. (time frame: 1-2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016; AzTrials last refreshed its copy on 8 Nov 2026.