Negative Oral Contrast Agents Utilization in PET/CT Studies

PET/CT Clinical Trial

Official title:

Negative Oral Contrast Agents Utilization in PET/CT Studies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04577586
• Other study ID #: Negative oral contrast PET/CT
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: Nahla mostafa Bashank, Phd
• Phone: 01009466255
• Email: nahla_bashank_2006[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Oral Contrast
• PET/CT

Intervention

Other:
• oral contrast
negative oral contrast utilization in PET/CT studies

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare the performance of different negative oral contrast agents in PET/Ct studies	comparing the effect of different oral contrast on bowel distention	baseline