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OpenTrials
Completed

NCT Number: NCT01721785

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Atrium Medisch Centrum, Heerlen, Limburg, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Ablavar, MS-325

Primary outcomes

  1. Diagnostic performance of the techniques under investigation

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Dutch Cancer Society

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2012
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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