Abbott Vital® as an Alternative Meal to the Gold-standard Egg-white Sandwich for Gastric Emptying Scintigraphy (GES)

Healthy Clinical Trial

Official title:

Abbott Vital® as an Alternative Meal to the Gold-standard Egg-white Sandwich for Gastric Emptying Scintigraphy (GES) Among Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04812301
• Other study ID #: USM/JEPeM/20120684
• Status: Completed
• Start date: March 17, 2021
• Est. completion date: March 25, 2021

Study information

• Verified date: April 2021
• Source: Universiti Sains Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This crossover study is designed to compare the rates of gastric emptying between two diagnostic radioactive meals using the gold-standard egg-white sandwich meal and Abbott Vital®. Healthy participants will be recruited and randomly assigned into either groups of Abbott Vital® and gold-standard egg-white sandwich group. The measurements will be performed over a 4-hour period using a gamma camera, and estimated gastric emptying rates will be calculated using established algorithms.

Description:

The gold-standard egg-white sandwich is quite difficult and complicated for staffs to prepare because the food needs to be cooked first and it will take time to prepare. Besides, the egg-white sandwich is not suitable for those with allergies to egg and bread and also to vegetarian patients. This gold-standard meal is also not a common meal for Asian people so some of the people may not tolerate with the meal. The aim of this study is to determine whether Abbott Vital® is as reliable as the gold-standard egg-white sandwich by comparing the gastric meal retention of both meals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 25, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Normal body mass index (BMI)
• Able to give consent
• 18 years old above

Exclusion Criteria:

• Vegetarian
• Allergy or cannot tolerate with milk, egg, and bread
• Participants with past and current history of chronic medical illness
• Currently on medication that can affect gastrointestinal function are also excluded

Related Conditions & MeSH terms

• Healthy

Intervention

Radiation:
• Egg-white sandwich
1 mCi of Tc-99m sodium phytate is added into the egg-white sandwich
• Abbott Vital®
1 mCi of Tc-99m sodium phytate is added into the Abbott Vital®

Locations

Country	Name	City	State
Malaysia	Hospital Universiti Sains Malaysia	Kota Bharu

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Sains Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (31)

Abell TL, Camilleri M, Donohoe K, Hasler WL, Lin HC, Maurer AH, McCallum RW, Nowak T, Nusynowitz ML, Parkman HP, Shreve P, Szarka LA, Snape WJ Jr, Ziessman HA; American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. Consensus recommendations for gastric emptying scintigraphy: a joint report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. J Nucl Med Technol. 2008 Mar;36(1):44-54. doi: 10.2967/jnmt.107.048116. Epub 2008 Feb 20. — View Citation

Banks, K. P., & McWhorter, N. (2018). Gastric Emptying Scan. In StatPearls. StatPearls Publishing. http://www.ncbi.nlm.nih.gov/pubmed/30285398

Co. (2017). CIS bio international, member of IBA Molecular group of companies PHYTACIS Kit for the preparation of technetium [ 99m Tc] phytate injection USER PACKAGE LEAFLET.

Cook AC, Anderson RH. Attitudinally correct nomenclature. Heart. 2002 Jun;87(6):503-6. — View Citation

Donohoe KJ, Maurer AH, Ziessman HA, Urbain JL, Royal HD, Martin-Comin J; Society for Nuclear Medicine; American Neurogastroenterology and Motility Society. Procedure guideline for adult solid-meal gastric-emptying study 3.0. J Nucl Med Technol. 2009 Sep;37(3):196-200. doi: 10.2967/jnmt.109.067843. Epub 2009 Aug 19. — View Citation

Farrell MB. Gastric Emptying Scintigraphy. J Nucl Med Technol. 2019 Jun;47(2):111-119. doi: 10.2967/jnmt.117.227892. Review. — View Citation

Farrell, M. B. (2017). Gastric Emptying Scintigraphy* GASTRIC EMPTYING SCINTIGRAPHY • Farrell. Abdominal Imaging, 2017. https://doi.org/10.2967/jnmt.117.227892

Fisher DR, Fahey FH. Appropriate Use of Effective Dose in Radiation Protection and Risk Assessment. Health Phys. 2017 Aug;113(2):102-109. doi: 10.1097/HP.0000000000000674. — View Citation

Frederic H. Fahey. (2018). 1 Basic Principles of SPECT and SPECT/CT and Quality Control. In SPECT and SPECT/CT. Georg Thieme Verlag. https://doi.org/10.1055/b-0038-149733

Halland M, Bharucha AE. Relationship Between Control of Glycemia and Gastric Emptying Disturbances in Diabetes Mellitus. Clin Gastroenterol Hepatol. 2016 Jul;14(7):929-36. doi: 10.1016/j.cgh.2015.11.021. Epub 2015 Dec 21. Review. — View Citation

ICRP. (1992a). Radiological Protection in Biomedical Research. Annals of ICRP, Pergamon Press. 62.

ICRP. (1992b). Radiological Protection in Biomedical Research. ICRP Publication 62. Ann. ICRP 22 (3). https://doi.org/10.1177/ANIB_22_3

Knight LC. Update on gastrointestinal radiopharmaceuticals and dosimetry estimates. Semin Nucl Med. 2012 Mar;42(2):138-44. doi: 10.1053/j.semnuclmed.2011.11.001. — View Citation

Kusano M, Zai H, Shimoyama Y, Hosaka H, Kuribayashi S, Kawamura O, Mori M. Rapid gastric emptying, rather than delayed gastric emptying, might provoke functional dyspepsia. J Gastroenterol Hepatol. 2011 Apr;26 Suppl 3:75-8. doi: 10.1111/j.1440-1746.2011.06627.x. — View Citation

Leiper JB. Fate of ingested fluids: factors affecting gastric emptying and intestinal absorption of beverages in humans. Nutr Rev. 2015 Sep;73 Suppl 2:57-72. doi: 10.1093/nutrit/nuv032. Review. Erratum in: Nutr Rev. 2020 Sep 1;78(9):781. — View Citation

Mackie AR, Rafiee H, Malcolm P, Salt L, van Aken G. Specific food structures supress appetite through reduced gastric emptying rate. Am J Physiol Gastrointest Liver Physiol. 2013 Jun 1;304(11):G1038-43. doi: 10.1152/ajpgi.00060.2013. Epub 2013 Apr 11. — View Citation

Malik R, Srivastava A, Gambhir S, Yachha SK, Siddegowda M, Ponnusamy M, Poddar U. Assessment of gastric emptying in children: Establishment of control values utilizing a standardized vegetarian meal. J Gastroenterol Hepatol. 2016 Feb;31(2):319-25. doi: 10.1111/jgh.13145. — View Citation

Mat Nawi N, Tagiling N, Mohd Rohani MF, Wan Zainon WMN, Zanial MS, Wong MS, Lee YY. (99m)Tc-sodium phytate is a valid alternative to the gold-standard (99m)Tc-sulfur colloid in the measurement of gastric emptying among healthy multi-ethnic Asian population: results of a randomized cross-over trial. BMC Gastroenterol. 2020 Aug 31;20(1):293. doi: 10.1186/s12876-020-01426-5. — View Citation

Maurer AH. Gastrointestinal Motility, Part 1: Esophageal Transit and Gastric Emptying. J Nucl Med. 2015 Aug;56(8):1229-38. doi: 10.2967/jnumed.112.114314. Epub 2015 May 29. Review. — View Citation

McKee JL, Farrell MB, Hunt K, Loveless V, Brannen C. Efficiency of Radiolabeling Eggs Before and After Microwave Cooking for Gastric Emptying Scintigraphy Studies. J Nucl Med Technol. 2019 Jun;47(2):144-148. doi: 10.2967/jnmt.118.225177. Epub 2019 Apr 24. — View Citation

Nolte T, Gross-Weege N, Schulz V. (Hybrid) SPECT and PET Technologies. Recent Results Cancer Res. 2020;216:111-133. doi: 10.1007/978-3-030-42618-7_3. Review. — View Citation

Papagiannopoulou D. Technetium-99m radiochemistry for pharmaceutical applications. J Labelled Comp Radiopharm. 2017 Sep;60(11):502-520. doi: 10.1002/jlcr.3531. Epub 2017 Aug 28. Review. — View Citation

Sachdeva P, Kantor S, Knight LC, Maurer AH, Fisher RS, Parkman HP. Use of a high caloric liquid meal as an alternative to a solid meal for gastric emptying scintigraphy. Dig Dis Sci. 2013 Jul;58(7):2001-6. doi: 10.1007/s10620-013-2665-2. Epub 2013 Apr 16. — View Citation

Solnes LB, Sheikhbahaei S, Ziessman HA. EnsurePlus as an Alternative to the Standardized Egg Gastric-Emptying Meal. Clin Nucl Med. 2019 Jun;44(6):459-461. doi: 10.1097/RLU.0000000000002553. — View Citation

Vasavid P, Chaiwatanarat T, Pusuwan P, Sritara C, Roysri K, Namwongprom S, Kuanrakcharoen P, Premprabha T, Chunlertrith K, Thongsawat S, Sirinthornpunya S, Ovartlarnporn B, Kachintorn U, Leelakusolvong S, Kositchaiwat C, Chakkaphak S, Gonlachanvit S. Normal Solid Gastric Emptying Values Measured by Scintigraphy Using Asian-style Meal:A Multicenter Study in Healthy Volunteers. J Neurogastroenterol Motil. 2014 Jul 31;20(3):371-8. doi: 10.5056/jnm13114. — View Citation

W.B. Saunders. (2014). Radiopharmaceuticals. In Nuclear Medicine (Fourt edit, pp. 1-15). Elsevier. https://doi.org/10.1016/B978-0-323-08299-0.00001-8

Wise JL, Vazquez-Roque MI, McKinney CJ, Zickella MA, Crowell MD, Lacy BE. Gastric Emptying Scans: Poor Adherence to National Guidelines. Dig Dis Sci. 2020 May 16. doi: 10.1007/s10620-020-06314-2. [Epub ahead of print] — View Citation

Wong GK, Shulman RJ, Chumpitazi BP. Gastric emptying scintigraphy results in children are affected by age, anthropometric factors, and study duration. Neurogastroenterol Motil. 2015 Mar;27(3):356-62. doi: 10.1111/nmo.12499. Epub 2015 Jan 4. — View Citation

World Health Organization. (2008). RADIOPHARMACEUTICALS Final text for addition to The International Pharmacopoeia. In International Pharmacopoeia (Vol. 2, Issue November, pp. 1-28). http://www-ns.iaea.org/standards/

Yang S, Bao W, Bai X, Gao C, Zhang B, Jiang Z. (99m)Tc-labeled sodium phytate and stannous chloride injection accurately detects sentinel lymph node in axillary of early stage breast cancer: a randomized, controlled study. Onco Targets Ther. 2018 Apr 4;11:1891-1898. doi: 10.2147/OTT.S155265. eCollection 2018. — View Citation

Zanzonico P. Principles of nuclear medicine imaging: planar, SPECT, PET, multi-modality, and autoradiography systems. Radiat Res. 2012 Apr;177(4):349-64. Epub 2012 Feb 27. Review. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of gastric emptying rates	Percentage of gastric meal retention (GMR; %)	4 hours (0 hour, 1/2-hour, 1-hour, 2-hour, 3-hour, 4-hour)
Secondary	Half-emptying time and slope	Time required by the stomach to empty 50% of the ingested meal (T1/2; minutes)	T1/2
Secondary	Symptoms and satiety/satiation	Intensity of perceived symptom and satiety/satiation based on Visual Analogue Scale (VAS)	4 hours (0 hour, 1/2-hour, 1-hour, 2-hour, 3-hour, 4-hour)