NCT04577586

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

October 8, 2020

Status Verified

September 1, 2020

Enrollment Period

6 months

First QC Date

September 30, 2020

Last Update Submit

September 30, 2020

Conditions

PET/CTOral Contrast

Outcome Measures

Primary Outcomes (1)

  • compare the performance of different negative oral contrast agents in PET/Ct studies

    comparing the effect of different oral contrast on bowel distention

    baseline

Study Arms (3)

Water

Patients who ingested only water as an oral contrast

Other: oral contrast

Milk

Patients who ingested milk as an oral contrast

Other: oral contrast

Mannitol

Patients who ingested mannitol as an oral contrast

Other: oral contrast

Interventions

oral contrastOTHER

negative oral contrast utilization in PET/CT studies

MannitolMilkWater

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, 71515, Egypt

RECRUITING

Related Publications (2)

  • 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.

    PMID: 23919067BACKGROUND

  • 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.

    PMID: 18430848BACKGROUND

MeSH Terms

Interventions

Contrast Media

Intervention Hierarchy (Ancestors)

Diagnostic Uses of ChemicalsPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Central Study Contacts

Nahla mostafa Bashank, Phd

CONTACT

01009466255nahla_bashank_2006@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 30, 2020

First Posted

October 8, 2020

Study Start

September 1, 2020

Primary Completion

March 1, 2021

Study Completion

April 1, 2021

Last Updated

October 8, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)