EUCTR2014-001619-37-NL
Active, not recruiting
Phase 1
Contrast enhanced Diffusion-weighted Magnetic Resonance Imaging for detection of pathologic lymph nodes in ovarian cancer – a feasibility study. - MILO
Maastricht University Medical Centre0 sites20 target enrollmentJune 3, 2014
ConditionsOvarian Cancer - diagnosis of lymph nodesTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
DrugsAblavar
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Ovarian Cancer - diagnosis of lymph nodes
- Sponsor
- Maastricht University Medical Centre
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Non\-pregnant female
- •Expected FIGO stage IIB\-IV epithelial ovarian carcinoma
- •Scheduled for primary debulking surgery
- •Written informed consent
- •At least 18 years of age.
- •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 10
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Patients estimated to have more benefit from neoadjuvant chemotherapy
- •Ineligibility to undergo MRI
- •Ineligibility to receive contrast agent
- •Previous para\-aortic or pelvic lymphadenectomy
- •History of a malignant tumour.
- •Pregnant or lactating patients.
Outcomes
Primary Outcomes
Not specified
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