Quicksilver: a study to assess the safety of a new MRI approach to pre-operatively stage rectal cancer and guide treatment

Phase 2

Completed

• Conditions: Rectal cancer; Cancer

• Registration Number: ISRCTN05107772
• Lead Sponsor: Mount Sinai Hospital (Canada)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-23
• Study Completion: 2018-06-01
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome for the study will be the safety of this new MRI approach in terms of positive circumferential resection margin (CRM) in the pathological specimen. The positive CRM rate is a well-established and accepted surrogate measure of local recurrence and the new MRI criteria will be considered safe if a positive CRM rate of less than 5% is achieved.