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Trial record 40 of 44 for:    Gadoxetate

Liver MRI for Colorectal Cancer Liver Metastasis: Comparative Effectiveness Research for the Choice of Contrast Agents

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ClinicalTrials.gov Identifier: NCT02652663
Recruitment Status : Unknown
Verified January 2016 by Yonsei University.
Recruitment status was:  Active, not recruiting
First Posted : January 12, 2016
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
Magnetic resonance imaging (MRI) has been widely used for problem-solving tool in the evaluation of hepatic lesions, and it has been shown to have better sensitivity than CT for detection of colorectal liver metastases, especially for lesions which are smaller than 1 cm. After introduction of a liver-specific hepatobiliary MR contrast agent, gadoxetic acid, gadoxetic acid-enhanced MRI (Gd-EOB-MRI) has been increasingly used for evaluation of liver lesion including CRLM. However, compared to conventional MRI with extracellular contrast agent (ECA-MRI), Gd-EOB-MRI has different pharmacodynamic characteristics, and is more expensive due to higher cost of gadoxetic acid and needs longer scan time to obtain hepatobiliary phase which is generally acquired 15 to 20 minutes after contrast injection. The purpose of this study was to compare the clinical outcome and diagnostic performance of Gd-EOB-MRI and ECA-MRI for evaluation of focal hepatic lesion in newly diagnosed colorectal cancer.

Condition or disease
Colorectal Cancer

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : January 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort
ECA-MRI group
ECA-MRI group (patients who underwent conventional MRI using extracellular contrast agent [ECA])
Gd-EOB-MRI group
Gd-EOB-MRI group (patients who underwent gadoxetic acid-enhanced MRI)



Primary Outcome Measures :
  1. Disease free survival [ Time Frame: up to 120 months ]
    From date of curative hepatic surgery until the date of first documented tumor recurrence or date of death from disease-related cause



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed colorectal cancer between January 2005 and December 2010
Criteria

Inclusion Criteria:

  1. patients with surgically proven colorectal adenocarcinoma
  2. patients who underwent abdominopelvic CT and liver MRI for initial staging before any treatment
  3. no past or concurrent malignancy other than colorectal adenocarcinoma.

Exclusion Criteria:

  1. precontrast abdominopelvic CT
  2. precontrast liver MRI
  3. liver MRI using contrast other than extracellular agent or gadoxetic acid
  4. the interval between CT and liver MRI was longer than 4 weeks
  5. patients who had suspected multiple hepatic metastases (> 10) on CT
  6. distant metastasis other than liver and
  7. unavailable reference standard of their hepatic lesions with no pathologic confirmation or follow up imaging.

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02652663     History of Changes
Other Study ID Numbers: 4-2015-1045
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plant to shae data
Keywords provided by Yonsei University:
colorectal cancer
liver
MRI
contrast
gadoxetic acid
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases