Gastric Emptying: in Vivo Studies in Healthy Volunteers

NCT02994472 | Unknown

• 1 other identifier: 205705
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Gastric Disease

Outcome Measures

Primary Outcomes (1)

• Participants subject to Gastric Emptying Scintigraphy, emptying time expressed relative to normal range.

  1-2 years

Study Arms (1)

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.

Radiation: Gastric emptying scintigraphy using 99mTc-DTPA

Interventions

Gastric emptying scintigraphy using 99mTc-DTPA RADIATION

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sandwell & West Birmingham Hospitals NHS Trust: lead

MeSH Terms

Conditions

Stomach Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Shazmeen Hansrod

  Sandwell and West Birmingham Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shazmeen Hansrod

CONTACT

0121 507 4044; s.hansrod@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scientist

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 15, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 15, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share