Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

• ClinicalTrials.gov Identifier: NCT00478556
• Recruitment Status: Completed
• First Posted: May 25, 2007
• Results First Posted: June 11, 2010
• Last Update Posted: April 18, 2017
• Sponsor: University of Alabama at Birmingham
• Collaborator: GE Healthcare
• Information provided by (Responsible Party): Michelle McNamara, MD, University of Alabama at Birmingham

Tracking Information

• First Submitted Date: May 24, 2007
• First Posted Date: May 25, 2007
• Results First Submitted Date: February 9, 2010
• Results First Posted Date: June 11, 2010
• Last Update Posted Date: April 18, 2017
• Study Start Date: August 2007
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 19, 2010)

Preferred Contrast Agent [ Time Frame: 1 Day ]

The primary outcome variable is the taste test when subjects will be asked which preparation they prefer. Possible answers include Onmipaque, Gastroview or neither.

• Original Primary Outcome Measures (submitted: May 24, 2007): The primary outcome variable is the taste test when subjects will be asked which preparation they prefer. Possible answers include Onmipaque, Gastroview or neither. [ Time Frame: Day of CT scan ]

Current Secondary Outcome Measures (submitted: May 19, 2010)

Bowel Opacification Score [ Time Frame: Collected day of study ]

The bowel opacification score was calculated by adding values for stomach, duodenum, jejunum and ileum for each patient. They were averaged across two doctors who read the studies. Scores can range from 0 (no opacification) to 3 (excellent) for each segment and from 0 to 12 for bowel opacification score.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT
• Official Title: Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT
• Brief Summary: Patients who are scheduled by their health care provider for routine computed tomography (CT) scan will be asked to participate in this study. The primary purpose is to determine if there is a difference in patient preference for Omnipaque versus Gastroview as oral contrast for abdominal pelvic CT. A secondary objective is to evaluate if there is significant difference in bowel opacification for the two agents.

Detailed Description

Participants must be scheduled for a CT scan prior to enrollment in this study. Informed consent will be obtained from patients acceptable to be included in the study. It will be noted if there is a history of gastrointestinal surgery and if the patient is nauseated before the contrast is administered.

Patients will be randomized to receive either a standardized dilution of Gastroview or Omnipaque orally. The two agents will be prepared to have nearly equivalent iodine concentration. No flavoring agent (ie Crystal Light) will be added. The plan is to mix the agents per manufacturer recommendation as follows:

Omnipaque 350 26cc in 974 cc of water (9.0g iodine) Gastroview 25cc in 1000cc of water (9.17g iodine)

The time the patients start and stop consuming the contrast as well as the volume taken and time from first drink to start of the scan will be recorded by a blinded investigator. Patients will be asked to drink 900cc. Technical staff will report any side effects or complications observed.

After completion of the CT scan, patients will fill in a survey rating the taste of the agent on a 5 point scale, and will be asked to report any side effects. Planned rating scale is as follows:

• 2=Dislike very much

• 1=Dislike moderately 0=Neither like nor dislike

  • 1=Like moderately
  • 2=Like very much

A taste test between the two agents will then be administered by a blinded investigator. Patients will be given 30 cc of each agent. The order in which the agents are administered will be randomized. Patients will be asked to rate preference, if any, for either agent on a 3 point scale. Potential bias related to which agent was administered for the CT will analyzed from the data.

Planned rating scale is as follows:

• 1- A is better 0 -no difference

  • 1- B is better

Patients will be contacted by telephone the day after the CT to assess for any delayed side effects such as diarrhea, constipation, and abdominal cramping experienced in the 24 hours following.

Bowel opacification will be rated by 2 body imagers blinded to the agent the patient received. Degree of opacification of the stomach, duodenum, jejunum, and ileum will be rated on a 4 point scale. If contrast has reached the colon, ascending, transverse, descending and sigmoid will be similarly evaluated. Four point rating scale is as follows:

0= absent opacification

1. minimal (<25% of analyzed segments opacified)
2. good (>25 % and < 75% of analyzed segments opacified)
3. excellent (> 75% of analyzed segments opacified)

Description of tests/procedures to be performed. Patients will undergo contrast enhanced abdominal pelvis CT as ordered by the referring clinician. Patients will be randomized to either dilute Omnipaque or dilute Gastroview for oral contrast. Both agents will be in a concentration of 9 mg of iodine/ml, and a volume of 900 cc.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Diagnostic
• Condition: Healthy

Intervention

• Drug: Omnipaque
  Oral CT contrast
  Other Name: Iohexol
• Drug: Gastroview
  Oral CT contrast
  Other Name: diatrizoate meglumine and diatrizoate sodium solution USP

Study Arms

• Active Comparator: 1
  Gastroview
  Intervention: Drug: Gastroview
• Experimental: 2
  Omnipaque
  Intervention: Drug: Omnipaque

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 19, 2010): 300
• Original Estimated Enrollment (submitted: May 24, 2007): 400
• Actual Study Completion Date: March 2009
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients at least 19 years of age scheduled for outpatient contrast enhanced abdominal pelvic CT at The Kirklin Clinic in Birmingham Alabama as part of clinical care with the patient's provider will be screened for eligibility.

Exclusion Criteria:

• Not competent to give consent.
• Pregnant.
• Known allergy to either of the contrast agents.
• Loss of sense of taste or smell.
• Contraindication to oral administration such as aspiration risk.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00478556
• Other Study ID Numbers: F070208011; Omnipaque vs Gastroview Oral ( Other Identifier: Department Name )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Michelle McNamara, MD, University of Alabama at Birmingham
• Original Responsible Party: Not Provided
• Current Study Sponsor: University of Alabama at Birmingham
• Original Study Sponsor: Same as current
• Collaborators: GE Healthcare

Investigators

• Principal Investigator: Michelle McNamara, MD; University of Alabama at Birmingham

• PRS Account: University of Alabama at Birmingham
• Verification Date: March 2017