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Clinical Trials/ISRCTN05107772
ISRCTN05107772
Completed
Phase 2

A Phase II prospective cohort study to assess the safety of a new MRI approach to pre-operatively stage rectal cancer and guide treatment

Mount Sinai Hospital (Canada)0 sites82 target enrollmentJuly 23, 2014
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ConditionsRectal cancerCancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Rectal cancer
Sponsor
Mount Sinai Hospital (Canada)
Enrollment
82
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30973610 [added 12/04/2019]

Registry
who.int
Start Date
July 23, 2014
End Date
June 1, 2018
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Diagnosis of rectal cancer (0\-15 cm) from the anal verge on endoscopy and/or proximal extent of tumour at or below the sacral promontory on CT or MRI
  • •2\. 18 years or older
  • •3\. Able to provide written consent

Exclusion Criteria

  • •1\. Planned abdomino\-perineal resection (APR) based on pre\-treatment assessment
  • •2\. Planned local excision based on pre\-treatment assessment
  • •3\. Suspicious extramesorectal lymph nodes on MRI
  • •4\. Unable to undergo MRI due to claustrophobia, metal fragments, implanted metal devices or contrast allergy
  • •5\. Metastatic disease (including extramesorectal lymph nodes, carcinomatosis, liver, lung)
  • •6\. Pregnancy
  • •7\. Inflammatory bowel disease
  • •8\. Previous pelvic radiation
  • •9\. More than one primary tumour

Outcomes

Primary Outcomes

Not specified

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