Colon Capsule Endoscopy (CCE) Versus Computed Tomographic Colonography (CTC) in the Identification of Colonic Polyps in a Screening Population. (TOPAZ)
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|ClinicalTrials.gov Identifier: NCT02754661|
Recruitment Status : Completed
First Posted : April 28, 2016
Results First Posted : October 1, 2019
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Screening||Device: COLON Capsule endoscopy Device: Computed Tomographic Colonography||Not Applicable|
This is a multicenter, prospective, randomized study to evaluate the efficacy of CCE versus CTC in the identification of colonic polyps in a screening population.
Subjects will be enrolled at up to 20 clinical sites in the United States. Subjects who meet the eligibility criteria will be screened by the gastroenterology site for study participation at a baseline visit which will also include a blood test for renal function (eGFR), and will be evaluated on the randomized procedure day (CCE versus CTC) and again on the day of both the blinded and unblinded OC procedures. Telephone follow-ups will be conducted 5 - 9 days after the CCE/CTC procedure and 5 - 9 days after the unblinded OC procedure to assess subject well-being and capture any Adverse Events (AEs), regardless of relationship to the CCE, CTC, or Optical colonoscopy (OC) procedures.
All CCE RAPID® videos and CTC images will be evaluated by local and central readers. All study analyses will be based on central reader results for both CCE and CTC. Two sets of central readers will be utilized, one set for reading of the CCE RAPID® videos and one set for reading the CTC studies. Both groups of readers will be experts in the reading process for their respective procedures. Readers will provide a report of their findings to the sponsor within 2 weeks of capsule ingestion or CTC procedure in order to allow subjects to return within 5 weeks capsule ingestion or CTC procedure to undergo confirmatory OC. The first OC procedure will be performed with the clinician blinded to the CCE or CTC results. Immediately following this blinded procedure, the clinician will review the CCE or CTC results report provided by the sponsor from the central readers, and a second unblinded OC procedure will be performed if there are discrepancies between the CCE/CTC findings and OC.
Colonoscopy must not be performed by the same person who conducts the local CCE reading, or anyone who has reviewed CCE/CTC results for that subject.
Bowel preparation regimens for all three procedure types will be standardized across sites.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||320 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Prospective, Randomized Study Comparing the Diagnostic Yield of Colon Capsule Endoscopy Versus Computed Tomographic Colonography in a Screening Population|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||August 7, 2018|
|Actual Study Completion Date :||August 7, 2018|
Experimental: COLON Capsule endoscopy
Subjects will be instructed to follow a detailed dietary and colon preparation regimen prior to and during the CCE procedure day. With the exception of Gastrografin, all colon preparation products will be standard colon cleansing products approved by the FDA.
Between 45 and 75 minutes after the final Polyethylene Glycol (PEG) ingestion, the subject will swallow the PillCam COLON Capsule with a cup of water.
If necessary, capsule position will be monitored to ensure adequate booster administration. Subjects will keep a timed diary of key preparation steps and bowel activity, including capsule excretion. Subjects will be allowed to leave the unit 10 hours after capsule ingestion if the capsule is not yet excreted. Subjects leaving before excretion will be instructed to disconnect the recorder at excretion or 12 hours after capsule ingestion (whichever comes first).
Device: COLON Capsule endoscopy
Active Comparator: Computed Tomographic Colonography
Subjects will be instructed to follow a detailed dietary and colon preparation regimen prior to and during the Computed Tomographic Colonography (CTC) procedure day.
The CTC procedure and study interpretation will be conducted in accordance with the ACR-SAR-SCBT-MR Practice Parameter for the Performance of CT Colonography in Adults. Colon insufflation will be performed with the subject in the lateral decubitus or supine position.With the subject in the supine position, a CT scout image will be taken to confirm adequate colon distention. If adequate bowel distention is not achieved, additional air will be insufflated into the colon. After scanning the subject in the supine position, the subject will be placed in the prone position, and additional CO2 will be administered. Subsequently, CT will be performed with the subject in the prone position. If a prone position is not possible for the subject, a left lateral decubitus position is preferred for optimal gas and fluid redistribution.
Device: Computed Tomographic Colonography
- Number of Participants With an Actionable Lesion on CCE vs. CTC Confirmed by Optical Colonoscopy [ Time Frame: 5-6 weeks from randomized procedure ]
Proportion of subjects shown to have an actionable lesion, defined as any polyp or mass lesion ≥6 mm.
Diagnostic yield of CCE/CTC will be calculated in relation to the confirmatory Optical colonoscopy results
- Sensitivity of CCE Versus CTC in the Detection of Polyps ≥6 mm [ Time Frame: 5-6 weeks from randomized procedure ]Sensitivity (the percentage of patients with disease who test positive) assessed in relation to the confirmatory optical colonoscopy (OC) results on a "per subject" basis
- Specificity of CCE Versus CTC in the Detection of Polyps ≥6 mm [ Time Frame: 5-6 weeks from randomized procedure ]Specificity (the percentage of patients without disease who test negative) assessed in relation to the confirmatory optical colonoscopy (OC) results on a "per subject" basis
- Predictive Value of a Positive Test (PPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm [ Time Frame: 5-6 weeks from randomized procedure ]Predictive value of a positive test (PPV) is the percentage of patients with positive tests who have disease assessed in relation to the confirmatory OC results on a "per subject" basis
- Predictive Value of a Negative (NPV) of CCE Versus CTC in the Detection of Polyps ≥6 mm [ Time Frame: 5-6 weeks from randomized procedure ]Predictive value of a negative test (NPV) is the percentage of patients with negative tests who do not have disease, assessed in relation to the confirmatory OC results on a "per subject" basis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754661
|United States, Alabama|
|University of South Alabama|
|Mobile, Alabama, United States, 36688|
|United States, Florida|
|Jacksonville, Florida, United States, 32256|
|United States, Illinois|
|Loyola University Medical Center|
|Chicago, Illinois, United States, 60153|
|United States, Indiana|
|Indiana University Hospital|
|Indianapolis, Indiana, United States, 46202|
|Indianapolis Gastroenterology and Hepatology|
|Indianapolis, Indiana, United States, 46237|
|United States, Massachusetts|
|Springfield, Massachusetts, United States, 01199|
|United States, Minnesota|
|Mayo Clinic Rochester|
|Rochester, Minnesota, United States, 55905|
|United States, Missouri|
|Clinical Research Professionals|
|Saint Louis, Missouri, United States, 63141|
|United States, New York|
|New York, New York, United States, 10016|
|New York, New York, United States, 10032|
|United States, North Carolina|
|Asheville Gastroenterology Associates|
|Asheville, North Carolina, United States, 28801|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Virginia|
|Virginia Gastroenterology institute|
|Suffolk, Virginia, United States, 23434|
|Principal Investigator:||Brooks Cash, MD||University of South Alabama|