Negative Oral Contrast Agents Utilization in PET/CT Studies

To compare the performance of different negative oral contrast agents in bowel distension in patient referred for PET/CT studies for various causes aiming for identification of ideal oral contrast agent(OCA).

Study Overview

• Status: Unknown
• Conditions: PET/CT; Oral Contrast
• Intervention / Treatment: Other: oral contrast

Detailed Description

Evaluation of gastrointestinal pathology depends on adequate bowel distention, which optimizes resolution of the bowel wall and contents. Traditionally, high-attenuation oral Contrast material in the form of iodine solutions or barium suspensions has been used to obtain bowel distension in MDCT examinations

Traditional high-contrast oral agents like iodine solutions, and barium suspensions which due to overcorrection problems in PET-CT interpretation lowers the accuracy of diagnosis. Negative oral contrast agents like water, air, fat containing agents used with 12.5% corn oil and polyethylene glycol has been used in radiological studies. Milk with 4% fat content has also been tested out in radiological studies and found to be effective. As it is more easily available, palatable, and acceptable especially, by children it needed to be tested in the visualization of the GIT in the PET-CT studies compared to other negative contrast agents.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Nahla mostafa Bashank, Phd; Phone Number: 01009466255; Email: nahla_bashank_2006@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Recruiting
    • Faculty of medicine
    • Contact: Nahla Bashank, MD; Phone Number: 01009466255; Email: nahla_bashank_2006@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients in our institution who prepared for PET-CT with administration of oral contrast material

Description

Inclusion Criteria:

• all patients referred to our unit for PET/CT study for various causes

Exclusion Criteria:

• Patients with GIT disease.
• Pregnancy and lactation.
• Severely ill patients.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Water; Patients who ingested only water as an oral contrast	Other: oral contrast; negative oral contrast utilization in PET/CT studies
Milk; Patients who ingested milk as an oral contrast	Other: oral contrast; negative oral contrast utilization in PET/CT studies
Mannitol; Patients who ingested mannitol as an oral contrast	Other: oral contrast; negative oral contrast utilization in PET/CT studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare the performance of different negative oral contrast agents in PET/Ct studies	comparing the effect of different oral contrast on bowel distention	baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Meyer SA, Gawde S. Utility of negative oral contrast (milk with 4% fat) in PET-CT studies. Indian J Nucl Med. 2012 Jul;27(3):151-5. doi: 10.4103/0972-3919.112719.
• Koo CW, Shah-Patel LR, Baer JW, Frager DH. Cost-effectiveness and patient tolerance of low-attenuation oral contrast material: milk versus VoLumen. AJR Am J Roentgenol. 2008 May;190(5):1307-13. doi: 10.2214/AJR.07.3193.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Negative oral contrast PET/CT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No