NCT04582500Completed
Virtual Colonoscopy Using Omnipaque as a Contrast Agent
Low-osmolar Contrast Tagging in Minimal Cathartic CT Colonography
Source: ClinicalTrials.gov · Last updated 4 Apr 2025
Brief summary (registry, in English)
CT colonography (CTC) is a validated screening exam for colorectal cancer. The diagnostic accuracy of CTC depends on the quality of the bowel cleansing and contrast tagging of residual stool and fluid. New bowel preparation media for CTC should be assessed for their efficacy and for patient satisfaction. Iohexol is currently approved by the FDA for oral use for imaging of the gastrointestinal tract. A potential advantage of using iohexol for CTC is that low-and iso-osmolar oral contrast agents have fewer risks than hyperosmolar contrast agents, which make them ideal for use in all patients, especially those who are frail and/or have multiple co-morbidities. For example, hyperosmolar contrast agents that are accidentally aspirated into the lungs during ingestion may result in life-threatening acute pulmonary edema and severe chemical pneumonitis, which is not the case for low- and iso-osmolar contrast agents. It may even be safer to use low- or iso-osmolar contrast agents for patients undergoing CTC on the same day as their incomplete colonoscopy, since they are at risk for aspiration from being sedated for their colonoscopy. Additionally, unlike hyperosmolar contrast agents, low- and iso-osmolar contrast agents do not cause sudden and massive fluid shifts, thus eliminating the risk of dangerous electrolyte imbalances.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 50 (actual)
- First submitted
- 30 Sept 2020
- Start date
- 15 Feb 2021
- Primary completion date
- 14 Mar 2024
- Lead sponsor
- Montefiore Medical Center
- Diseases
- Colorectal cancer
- NCT number
- NCT04582500
What you commit to
- Study type: Observational
- Participants enrolled: 50
- From 15 Feb 2021 to the primary completion date, 14 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- diuretic therapy, and
- enrollment in other clinical research trials involving investigational drugs
Other illness
- hypersensitivity to iodine-containing compounds,
Other
- pregnant or lactating,
Who the study is looking for
- age ≥18 years
- able to provide written informed consent
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.