Magnetic Resonance Imaging, Neoplasms Staging, Rectal Neoplasms
Conditions
Keywords
Nodal imaging, Restaging
Brief summary
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.
Detailed description
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.
Interventions
DRUGGADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar]
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.
Sponsors
Dutch Cancer Society
Maastricht University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of the techniques under investigation | 2 years | Techniques under investigation are diffusion-weighted imaging for tumour response assessment and gadofosveset-enhanced MRI for nodal assessment, compared to standard T2-weighted MRI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine the inter-observer agreement for the imaging techniques under investigation | 2 years | Detection of the differences between expert vs non-expert readers and general vs referral centres concerning diffusion-weighted imaging and gadofosveset-enhanced MRI. |
Countries
Netherlands
Outcome results
None listed