Comparing Pertechnetate SPECT/CT and Intragastric Pressure During Nutrient Drink for Gastric Accommodation

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.

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 Overview

• Status: Completed
• Conditions: Functional Dyspepsia; Healthy Volunteers
• Intervention / Treatment: Radiation: 99mTc-pertechnetate SPECT/CT; Procedure: Combined High-Resolution Manometry-Nutrient Drink Test

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 16150
      • Universiti Sains Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Healthy volunteers

Inclusion Criteria:

• 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

Exclusion Criteria:

• • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPECT/CT or HRM-NDT	Radiation: 99mTc-pertechnetate SPECT/CT; This procedure is similar to standard Meckel's diverticulum scan, with the addition of SPECT/CT acquisition to measure gastric volume.; Procedure: Combined High-Resolution Manometry-Nutrient Drink Test; Proximal gastric high-resolution manometry was done concurrently with nutrient drink test to measure proximal gastric function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants completing each procedure	• Feasibility assessed as technical success (number of participants completing each procedure).	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)	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.	From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	During the procedure, 1 day
Nutrient drink tolerance	• Maximum tolerated volume (in mL): Number of drink volume required to achieve satiety	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.	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")	During the procedure, 1 day

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Investigators: Study Director: Yeong Yeh Lee, MD, PhD, Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): February 27, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Estimated): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Sodium Pertechnetate Tc 99m
• Other Study ID Numbers: USM/JEPeM/19040249

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No