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
  Purpose

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.


Condition
Colon Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of the Diagnostic Accuracy of 3D Volume Acquisition MRI With CT in Staging Colonic Cancer

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 62
Study Start Date: August 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
colon cancer
patients undergoing treatment for colon cancer

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with colon cancer

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187641

Contacts
Contact: Dr Gina Brown 02086613964 gina.brown@rmh.nhs.uk
Contact: Dr Christopher Hunter chris_j_hunter@hotmail.com

Locations
United Kingdom
The Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Dr Gina Brown    02086613964    gina.brown@rmh.nhs.uk   
Contact: Dr Christopher Hunter       chris_j_hunter@hotmail.com   
Principal Investigator: Dr Gina Brown         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Dr Gina Brown Royal Marsden NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Dr Gina Brown, Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01187641     History of Changes
Other Study ID Numbers: CCR3370
Study First Received: August 23, 2010
Last Updated: August 26, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Marsden NHS Foundation Trust:
cancer, colon, MRI scan

ClinicalTrials.gov processed this record on September 30, 2014