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All patients will be treated according to standard practice of the concerning hospital.

Patients in group I are patients that will be stratified for direct surgery (TME) or a short-course of radiotherapy (5x5 Gy) followed by immediate TME.

Group I will undergo only a staging MRI, including gadofosveset-enhanced MRI.

All patients will be treated according to standard practice of the concerning hospital.

Patients in group II are patients that will be stratified for a long course of chemoradiotherapy.

Group II will undergo a staging MRI, a re-staging MRI and a optional sigmoidoscopy as part of restaging. MRI includes diffusion-weighted imaging and gadofosveset-enhanced MRI.

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.

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

Regina Beets-Tan, Prof. MD.

Geerard Beets, Ass Prof. MD

Doenja Lambregts, MD

Monique Maas, MD

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.

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer	NCT01721785	Rectal Neoplasm... Magnetic Resona... Neoplasms Stagi...	GADOFOSVESET TR...	18 Years -	Maastricht University Medical Center
Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer	NCT01721785	Rectal Neoplasm... Magnetic Resona... Neoplasms Stagi...	GADOFOSVESET TR...	18 Years -	Maastricht University Medical Center

Spots Global Cancer Trial Database for gadofosveset trisodium 244 mg in 1 ml intravenous injection, solution [ablavar]