To determine the value of new MRI techniques for the diagnosis of rectal cancer

Phase 1

• Conditions: rectal cancer; MedDRA version: 14.1Level: SOCClassification code 10047065Term: Vascular disordersSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 14.1Level: SOCClassification code 10040785Term: Skin and subcutaneous tissue disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 14.1Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 14.1Level: SOCClassification code 10018065Term: General disorders and administration site conditionsSystem Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 14.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002935-27-NL
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-13
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified