Virtual Colonoscopy Using Omnipaque as a Contrast Agent

NCT04582500 | Completed FDA Drug

• 1 other identifier: 2018-9791
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colorectal Cancer

Keywords

Screening

Outcome Measures

Primary Outcomes (6)

• adequate bowel preparation

  Two experienced board-certified abdominal imaging radiologists trained in reading CTC will assess percent bowel preparation

  Within 3 business days of completing CTC

• Amount of residual fluid and stool

  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%

  Within 3 business days of completing CTC

• Efficacy of residual fluid and stool

  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%

  Within 3 business days of completing CTC

• Amount of colonic bubbles

  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%

  Within 3 business days of completing CTC

• Attenuation of tagged fluid

  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) It will be recorded in Hounsfield units from Region of Interest (ROI) of fluid in each segment

  Within 3 business days of completing CTC

• Patient Satisfaction

  Patient satisfaction with Omnipaque 350 as part of their bowel preparation regimen will be assessed with Likert scales in a questionnaire that patient will be asked to fill out after CTC.

  immediately after CTC

Secondary Outcomes (1)

• Assessing Workflow of incomplete colonoscopies

  through study completion, an average of 1 year

Study Arms (1)

patients undergoing CTC receiving iohexol

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

Drug: Iohexol

Interventions

Iohexol DRUG

Iohexol (Omnipaque; GE Healthcare, Milwaukee, WI) is a low-osmolar non-ionic iodinated contrast agent that is approved by the FDA for oral use. It is routinely used orally for CT scans of the abdomen and pelvis, and has been used experimentally in CTC. Iohexol is better tolerated by patients and has a better safety profile than hyperosmolar iodinated and barium based contrast agents.

Also known as: OMNIPAQUE

patients undergoing CTC receiving iohexol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from a pool scheduled to undergo screening or diagnostic CTC for clinical purposes.

You may qualify if:

• age ≥18 years
• able to provide written informed consent

You may not qualify if:

• hypersensitivity to iodine-containing compounds,
• pregnant or lactating,
• diuretic therapy, and
• enrollment in other clinical research trials involving investigational drugs

Sponsors & Collaborators

• Montefiore Medical Center: lead
• GE Healthcare: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

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MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Iohexol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Judy Yee, MD, FACR

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 9, 2020
• Study Start: February 15, 2021
• Primary Completion: March 14, 2024
• Study Completion: March 31, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)