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


N/A
18 Years
N/A
Open (Enrolling)
Both
Rectal Neoplasms, Magnetic Resonance Imaging, Neoplasms Staging

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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
population.


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

Type of Study:

Observational

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:

No

Principal Investigator

Regina Beets-Tan, Prof. MD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radiology, MUMC

Authority:

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

Study ID:

12-2-051

NCT ID:

NCT01721785

Start Date:

October 2012

Completion Date:

June 2015

Related Keywords:

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

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