Comparison of the Diagnostic Accuracy of 3D Volume Acquisition MRI With CT in Staging Colonic Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Royal Marsden NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01187641
First received: August 23, 2010
Last updated: August 26, 2010
Last verified: August 2010

August 23, 2010
August 26, 2010
August 2010
September 2011   (final data collection date for primary outcome measure)
The primary endpoint will be the accuracy of MRI and CT in determining T stage using histology as the gold standard, on a per patient basis. [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01187641 on ClinicalTrials.gov Archive Site
  • Secondary endpoints will be the accuracy of CT and MRI in determining N stage, depth of invasion beyond the muscularis propria, and EMVI. [ Designated as safety issue: No ]
  • We will also compare the accuracy of 1.5T against 3.0T MRI scans, and T2 weighted against T1 weighted images [ Designated as safety issue: No ]
Secondary endpoints will be the accuracy of CT and MRI in determining N stage, depth of invasion beyond the muscularis propria, and EMVI. We will also compare the accuracy of 1.5T against 3.0T MRI scans, and T2 weighted against T1 weighted images [ Designated as safety issue: No ]
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Comparison of the Diagnostic Accuracy of 3D Volume Acquisition MRI With CT in Staging Colonic Cancer
Comparison of the Diagnostic Accuracy of 3D Volume Acquisition MRI With CT in Staging Colonic Cancer

The purpose of this study is to determine whether MRI is more accurate than CT in determining the T stage, N stage, depth of tumour invasion and extra mural venous invasion (EMVI) preoperatively in colon cancer.

The patient will proceed with their usual colon cancer assessment and treatment, including colonoscopy with biopsy and histology and preoperative CT chest abdomen and pelvis. In addition, patients who enroll in the study will have 2 preoperative MRIs of their abdomen and pelvis performed. One of these will be performed on a 1.5T and the other will be performed on a 3.0T MRI scanner. We will use 20mg of IM buscopan to reduce bowel mobility for each scan. A coronal scout scan will be taken to identify the tumour and select the target volume. IV gadolinium (a contrast agent routinely used in MRI scans to help identify different tissues) will be administered, and a 3D VIBE scan (T1 weighted) will be performed of the target volume. The liver will also be imaged at this time to look for liver metastases. A T2 weighted 3D volume acquisition will then be obtained of the target volume containing the tumour (and its lymphatic drainage).

The MRI will be independently reported by an expert without knowledge of the results of any other investigations. The results of the MRI scan will then be made available to the clinical team. The patient will then proceed as normal with any other investigation which the clinical team feel is necessary, and be treated as normal for their colon cancer. The patient will proceed with their surgery as normal, and the specimen removed at the time of the operation will be examined in the pathology laboratory to determine the exact stage of the cancer.

The accuracy of CT and MRI in staging colon cancer will then be determined against the reference standard provided by the histology examination.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

patients with colon cancer

Colon Cancer
Not Provided
colon cancer
patients undergoing treatment for colon cancer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
62
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients undergoing treatment for colon cancer
  • patients undergoing primary surgery for colon cancer and who do not require neo-adjuvant therapy on the basis of their pre-operative CT

Exclusion Criteria:

  • age <18
  • unable to consent
  • consent withheld or withdrawn
  • Unable to have an MRI (e.g pacemaker, metal implant)
  • Allergy or contraindications to busocopam, gadolinium, small bowel contrast agent
Both
18 Years and older
No
Contact: Dr Gina Brown 02086613964 gina.brown@rmh.nhs.uk
Contact: Dr Christopher Hunter chris_j_hunter@hotmail.com
United Kingdom
 
NCT01187641
CCR3370
No
Dr Gina Brown, Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
Not Provided
Principal Investigator: Dr Gina Brown Royal Marsden NHS Foundation Trust
Royal Marsden NHS Foundation Trust
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP