Clinical trial · Observational
Virtual Colonoscopy Using Omnipaque as a Contrast Agent
Low-osmolar Contrast Tagging in Minimal Cathartic CT Colonography
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iohexol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- patients undergoing CTC receiving iohexol
- description
- Patients will be recruited from a pool scheduled to undergo screening or diagnostic CTC for clinical purposes. They will be given 50 ml of Iohexol as a oral contrast
- interventionNames
- Drug: Iohexol
Primary outcomes (6)
- measure
- adequate bowel preparation
- timeFrame
- Within 3 business days of completing CTC
- description
- Two experienced board-certified abdominal imaging radiologists trained in reading CTC will assess percent bowel preparation
- measure
- Amount of residual fluid and stool
- timeFrame
- Within 3 business days of completing CTC
- description
- Two experienced board-certified abdominal imaging radiologists trained in reading CTC will assess residual fluid in each of the six segments of the colon (cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum)- Each segment will be scored as - 1 - none, 2 - \<25%, 3 - 25-50%, 4: 50-75%, 5: \>75%
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age ≥18 years * able to provide written informed consent Exclusion Criteria: * hypersensitivity to iodine-containing compounds, * pregnant or lactating, * diuretic therapy, and * enrollment in other clinical research trials involving investigational drugs
References
Publications (36)
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- BACKGROUNDAmerican Cancer Society. Colorectal Cancer Facts & Figures 2014-2016. Atlanta: American Cancer Society, 2014
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