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Clinical Trials/EUCTR2012-002935-27-NL
EUCTR2012-002935-27-NL
Active, not recruiting
Phase 1

Diagnostic value of novel MR imaging techniques for the primary staging and restaging of rectal cancer

Maastricht University Medical Center0 sitesDecember 13, 2012

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
rectal cancer
Sponsor
Maastricht University Medical Center
Status
Active, not recruiting
Last Updated
9 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 13, 2012
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • \-Biopsy proven primary rectal cancer (\=15 cm from the anorectal verge as measured on MRI)
  • \-Age \>18 years
  • \-Written informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 250
  • F.1\.3 Elderly (\>\=65 years) yes
  • F.1\.3\.1 Number of subjects for this age range 200

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

Outcomes

Primary Outcomes

Not specified

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