Diagnostic value of novel MR imaging techniques for the primary staging and restaging of rectal cancer

Phase 3

Completed

• Conditions: Rectal cancer; colorectal cancer; 10017990; 10017991

• Registration Number: NL-OMON39816
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 450

Inclusion Criteria

- Biopsy proven primary rectal cancer (*15 cm from the anorectal verge as measured on MRI);- Age >18 years;- Written informed consent

Exclusion Criteria

- Ineligibility to undergo MRI (claustrophobia, pacemaker, non-MR compatible surgical implants, metal fragments in the eye);- Pregnancy;- Locally recurrent rectal cancer;- A history of severe allergy to contrast agents;- Ineligibility to receive gadofosveset contrast (history of contrast allergy, impaired kidney function with a Glomerular Filtration Rate <30 ml/min/1.73m2;- Incurable disease due to metastases or co-morbidity

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the diagnostic performance of the techniques under<br /><br>investigation (gadofosveset-enhanced MRI for nodal assessment and DWI for the<br /><br>tumour response assessment after chemoradiotherapy). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.a.</p><br>