Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer

Maastricht University Medical Center307 enrolled

Overview

The purpose of this study is to determine the clinical value of the novel MRI-techniques DWI and gadofosveset-enhanced MRI for the management of rectal cancer patients.

Rectal cancer is a common form of cancer, and the treatment stratification depends on tumour and nodal stage as determined on MRI. Unfortunately, the information provided by standard T2-weighted MRI is not sufficient to accurately assess nodal involvement and tumour response after neo-adjuvant chemoradiotherapy. Additional functional information is required for reliable (re)staging. Diffusion-weighted imaging and gadofosveset-enhanced MRI are two new imaging techniques that have all shown great potential in rectal cancer staging. In order to provide definite evidence there is a need for a multicenter study with a large patient population.

Study Type

OBSERVATIONAL

Enrollment

307

Conditions

Rectal Neoplasms Magnetic Resonance Imaging Neoplasms Staging

Interventions

GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar]DRUG

Gadofosveset will be used as a lymph-node specific MRI contrast agent and will be administered by manual injection as a single intravenous bolus during MRI.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Biopsy proven primary rectal cancer (≤15 cm from the anorectal verge as measured in 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

Locations (10)

Atrium Medisch Centrum

Heerlen, Limburg, Netherlands

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Orbis Medisch Centrum

Sittard-Geleen, Limburg, Netherlands

Outcomes

Primary Outcomes

Diagnostic performance of the techniques under investigation

Techniques under investigation are diffusion-weighted imaging for tumour response assessment and gadofosveset-enhanced MRI for nodal assessment, compared to standard T2-weighted MRI.

Time frame: 2 years

Secondary Outcomes

To determine the inter-observer agreement for the imaging techniques under investigation

Detection of the differences between expert vs non-expert readers and general vs referral centres concerning diffusion-weighted imaging and gadofosveset-enhanced MRI.

Time frame: 2 years

Data from ClinicalTrials.gov

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