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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN05107772
Enrollment
75
Registered
2014-07-23
Start date
2014-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer Cancer

Interventions

Participants (i.e., rectal cancer patients) in this study will receive the exact same tests and surgery that they would receive if they were not participating in this study. However, instead of using

Sponsors

Mount Sinai Hospital (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 110 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 3, 2026