Healthy VolunteersNCT06673719
Comparing Pertechnetate SPECT/CT and Intragastric Pressure During Nutrient Drink for Gastric Accommodation
A study testing 99mTc-pertechnetate SPECT/CT and Combined High-Resolution Manometry-Nutrient Drink Test in people with Healthy Volunteers and Functional Dyspepsia, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
Functional dyspepsia (FD) is a common gastrointestinal disorder which can present with early satiety, postprandial fullness, epigastric pain and burning sensation in the absence of underlying disease. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Functional Dyspepsia
- What is being tested?
- 99mTc-pertechnetate SPECT/CT and Combined High-Resolution Manometry-Nutrient Drink Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2019to 15 Mar 2020
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient is above 18 years-old.
- No current gastrointestinal symptoms
- No previous gastrointestinal illness such as peptic ulcer disease or gastritis
- No chronic medical illness such as chronic neurological, cardiovascular, pulmonary, endocrine and hematological disorders
- Does not fulfill Rome IV criteria for functional dyspepsia
Who cannot join
- • Had undergone any abdominal surgery except appendicectomy, tubal ligation or Caesarean section
- Use of medications such as metoclopramide, domperidone, erythromycin and itopride that may alter gastrointestinal function and motility
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Validity of 99mTc-pertechnetate SPECT/CT and Mean Intragastric Pressure During Nutrient Drink in the Measurement of Gastric Accommodation
Functional dyspepsia (FD) is a common gastrointestinal disorder which can present with early satiety, postprandial fullness, epigastric pain and burning sensation in the absence of underlying disease. The most troubling symptom is weight loss, prevalent in up to 40% of FD patients and is often associated with impaired gastric accommodation.
Gastric accommodation by definition is a reflex, mediated vagally which causes reduction in gastric tone, increased in compliance and increment in gastric volume post meal ingestion. It allows large volumes of liquid or solid ingestion without causing postprandial symptoms. Impairment of gastric accommodation has been linked to gastrointestinal symptoms which includes nausea, bloating, early satiety, weight loss and epigastric pain.
Read more
There are several studies aimed to assess efficacy in the treatment of functional dyspeptic patients. A myriad of tests can measure gastric accommodation such as gastric barostat and single photon emission computed tomography (SPECT). An alternative study known as the nutrient drink test has also been proposed and can be combined with high-resolution manometry.
So far, none of the nuclear medicine centers in Malaysia are providing clinical service for radionuclide gastric accommodation study. The gold standard for gastric accommodation assessment is the gastric barostat method. However, the technique is invasive and caused discomfort to patients. Radionuclide gastric accommodation study using 99mTc-pertechnetate with SPECT/CT is a non-invasive method that can be used to assess patient with FD and enables quantitative evaluation of treatment response to medications. Hence, the role of non-invasive gastric volume assessment with 99mTc-pertechenate SPECT/CT in the evaluation of healthy individuals was studied first, and then compared with intragastric pressure measurements from high-resolution manometry and nutrient drink test.
- Conditions
- Healthy Volunteers, Functional Dyspepsia
- Being tested
- 99mTc-pertechnetate SPECT/CT, Combined High-Resolution Manometry-Nutrient Drink Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-pertechnetate SPECT/CTRadiation
This procedure is similar to standard Meckel's diverticulum scan, with the addition of SPECT/CT acquisition to measure gastric volume.
Combined High-Resolution Manometry-Nutrient Drink TestProcedure or surgery
Proximal gastric high-resolution manometry was done concurrently with nutrient drink test to measure proximal gastric function.
| Study group | Role | What they receive |
|---|---|---|
| SPECT/CT or HRM-NDT | Experimental | Not described Receives: Radiation: 99mTc-pertechnetate SPECT/CT; Procedure: Combined High-Resolution Manometry-Nutrient Drink Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants completing each procedure
- Feasibility assessed as technical success (number of participants completing each procedure).
Measured: From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)
Duration (time) of each procedural session
- Feasibility assessed as procedural duration (time taken to complete one procedure)
Measured: From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)
Incidence of adverse event
- Tolerability assessed as incidence of adverse event over study period using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)
Secondary outcomes (5)
Gastric volume measured using SPECT/CT
- Gastric volume (in mL): Fasting state, postprandial state (after single-serving of 250 mL nutrient drink). All are to be measured in one session and as one outcome.
Measured: During the procedure, 1 day
Proximal gastric pressure measured using high-resolution manometry
- Proximal gastric pressure (in mmHg): baseline (fasting) pressure recording, prandial pressure recording, postprandial pressure recording. All are to be measured in one session and as one outcome.
Measured: During the procedure, 1 day
Nutrient drink tolerance
- Maximum tolerated volume (in mL): Number of drink volume required to achieve satiety
Measured: During the procedure, 1 day
Dyspeptic symptoms measured using numerical rating scales
- Dyspeptic symptom responses: Numerical rating scale with verbal descriptors on 4 symptoms i.e., epigastric pain, bloating, fullness, nausea (from 0 to 3: 0 means "no symptoms", 3 means "severe"). All are to be measured in one session using one instrument and as one outcome.
Measured: During the procedure, 1 day
Satiation score measured using numerical rating scales
- Satiation (presented as satiation-unit): Numerical rating scale with verbal descriptors (from 0 to 5: 0 means "not full", 5 means "maximum fullness")
Measured: During the procedure, 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Oct 2019
- Primary completion27 Feb 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric, non-randomized sequence, pilot and feasibility study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nashrulhaq Tagiling, MSc, Universiti Sains Malaysia
- Investigators
- Yeong Yeh Lee, MD, PhD, Study director, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673719
- Sponsor's protocol ID
- USM/JEPeM/19040249
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Validity of 99mTc-pertechnetate SPECT/CT and Mean Intragastric Pressure During Nutrient Drink in the Measurement of Gastric Accommodation
- ClinicalTrials.gov ID
- NCT06673719
- Acronym / sponsor ID
- USM/JEPeM/19040249
- Conditions
- Healthy Volunteers, Functional Dyspepsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 5 Nov 2024 (actual)
- 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.
Functional dyspepsia (FD) is a common gastrointestinal disorder which can present with early satiety, postprandial fullness, epigastric pain and burning sensation in the absence of underlying disease. The most troubling symptom is weight loss, prevalent in up to 40% of FD patients and is often associated with impaired gastric accommodation.
Gastric accommodation by definition is a reflex, mediated vagally which causes reduction in gastric tone, increased in compliance and increment in gastric volume post meal ingestion. It allows large volumes of liquid or solid ingestion without causing postprandial symptoms. Impairment of gastric accommodation has been linked to gastrointestinal symptoms which includes nausea, bloating, early satiety, weight loss and epigastric pain.
There are several studies aimed to assess efficacy in the treatment of functional dyspeptic patients. A myriad of tests can measure gastric accommodation such as gastric barostat and single photon emission computed tomography (SPECT). An alternative study known as the nutrient drink test has also been proposed and can be combined with high-resolution manometry.
So far, none of the nuclear medicine centers in Malaysia are providing clinical service for radionuclide gastric accommodation study. The gold standard for gastric accommodation assessment is the gastric barostat method. However, the technique is invasive and caused discomfort to patients. Radionuclide gastric accommodation study using 99mTc-pertechnetate with SPECT/CT is a non-invasive method that can be used to assess patient with FD and enables quantitative evaluation of treatment response to medications. Hence, the role of non-invasive gastric volume assessment with 99mTc-pertechenate SPECT/CT in the evaluation of healthy individuals was studied first, and then compared with intragastric pressure measurements from high-resolution manometry and nutrient drink test.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric, non-randomized sequence, pilot and feasibility study
| Arm | Type | Receives |
|---|---|---|
| SPECT/CT or HRM-NDT | Experimental | Radiation: 99mTc-pertechnetate SPECT/CT, Procedure: Combined High-Resolution Manometry-Nutrient Drink Test |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is above 18 years-old.
- No current gastrointestinal symptoms
- No previous gastrointestinal illness such as peptic ulcer disease or gastritis
- No chronic medical illness such as chronic neurological, cardiovascular, pulmonary, endocrine and hematological disorders
- Does not fulfill Rome IV criteria for functional dyspepsia
Key exclusion criteria (3 listed)
- • Had undergone any abdominal surgery except appendicectomy, tubal ligation or Caesarean section
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 |
|---|---|---|
| 99mTc-pertechnetate SPECT/CTThis procedure is similar to standard Meckel's diverticulum scan, with the addition of SPECT/CT acquisition to measure gastric volume. | Radiation | SPECT/CT or HRM-NDT |
| Combined High-Resolution Manometry-Nutrient Drink TestProximal gastric high-resolution manometry was done concurrently with nutrient drink test to measure proximal gastric function. | Procedure or surgery | SPECT/CT or HRM-NDT |
Primary outcome
Number of participants completing each procedure
Time frame: From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)
• Feasibility assessed as technical success (number of participants completing each procedure).
Duration (time) of each procedural session
Time frame: From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)
• Feasibility assessed as procedural duration (time taken to complete one procedure)
Incidence of adverse event
Time frame: From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)
• Tolerability assessed as incidence of adverse event over study period using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
5 secondary outcomes
Gastric volume measured using SPECT/CT
Time frame: During the procedure, 1 day
Proximal gastric pressure measured using high-resolution manometry
Time frame: During the procedure, 1 day
Nutrient drink tolerance
Time frame: During the procedure, 1 day
Dyspeptic symptoms measured using numerical rating scales
Time frame: During the procedure, 1 day
Satiation score measured using numerical rating scales
Time frame: During the procedure, 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Yeong Yeh Lee, MD, PhD study director
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 99mTc-pertechnetate SPECT/CT and Combined High-Resolution Manometry-Nutrient Drink Test in people with Healthy Volunteers and Functional Dyspepsia, run by Universiti Sains Malaysia at 1 site in Malaysia.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants completing each procedure (time frame: From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)). The study lists 3 primary outcomes in all. 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 5 Nov 2024.