Negative Oral Contrast Agents Utilization in PET/CT Studies

• Conditions: PET/CT; Oral Contrast
• Interventions: Other: oral contrast

• Registration Number: NCT04577586
• Lead Sponsor: Assiut University

Brief Summary

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).

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 Timeline

• Status Verified: 2020-09
• Study Start: 2020-09-01
• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-09-30
• Last Update Submitted: 2020-09-30
• Study First Posted: 2020-10-08
• Last Update Posted: 2020-10-08
• Primary Completion: 2021-03-01
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Water	oral contrast	Patients who ingested only water as an oral contrast
Milk	oral contrast	Patients who ingested milk as an oral contrast
Mannitol	oral contrast	Patients who ingested mannitol as an oral contrast

Primary Outcome Measures

Name	Time	Method
compare the performance of different negative oral contrast agents in PET/Ct studies	baseline	comparing the effect of different oral contrast on bowel distention

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt