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
Conditionsrectal cancerMedDRA version: 14.1Level: SOCClassification code 10047065Term: Vascular disordersSystem Organ Class: 10047065 - Vascular disordersMedDRA version: 14.1Level: SOCClassification code 10040785Term: Skin and subcutaneous tissue disordersSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 14.1Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.1Level: SOCClassification code 10018065Term: General disorders and administration site conditionsSystem Organ Class: 10018065 - General disorders and administration site conditionsMedDRA version: 14.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Cancer [C04]
DrugsAblavar
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.
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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