Know Cancer

forgot password

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

18 Years
Open (Enrolling)
Rectal Neoplasms, Magnetic Resonance Imaging, Neoplasms Staging

Thank you

Trial Information

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

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

Inclusion Criteria:

- Biopsy proven primary rectal cancer (≤15 cm from the anorectal verge as measured in

- 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Diagnostic performance of the techniques under investigation

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Regina Beets-Tan, Prof. MD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radiology, MUMC


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

October 2012

Completion Date:

June 2015

Related Keywords:

  • Rectal Neoplasms
  • Magnetic Resonance Imaging
  • Neoplasms Staging
  • Nodal imaging
  • Restaging
  • Neoplasms
  • Rectal Neoplasms