Magnetic resonance Imaging for Lymph node staging in Ovarian cancer

Contrast enhanced Diffusion-weighted Magnetic Resonance Imaging for detection of pathologic lymph nodes in ovarian cancer – a feasibility study. - MILO

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001619-37-NL

Enrollment

Registered

2014-06-03

Start date

2014-07-14

Completion date

Unknown

Last updated

2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer - diagnosis of lymph nodes

Interventions

Trade Name: Ablavar gadofosveset trisodium Product Name: Ablavar (gadofosveset trisodium Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion 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 F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to determine the optimal imaging settings and feasibility for the detection of pathological lymph nodes in women with ovarian cancer with the use of magnetic resonance imaging (MRI) combined with diffusion weighted MRI (DW-MRI) and contrast enhanced MRI (CE-MRI) with gadofosveset (Ablavar™). ;Secondary Objective: PThe secondary objectives are to compare the accuracy of MRI with conventional CT imaging in a pilot study;Primary end point(s): In this pilot study the main objective is to determine the optimal imaging settings and feasibility of MRI combined with DW-MRI and gadofosveset (Ablavar™) CE-MRI in with advanced stage epithelial ovarian cancer. A statistical analysis will not be performed for the primary endpoint. ;Timepoint(s) of evaluation of this end point: After administration of the contrast agent Ablavar, MRI images will be made and these will be evaluated within 7 days after the MRI scan.	—

Measure

Time frame

Main Objective: The primary objective is to determine the optimal imaging settings and feasibility for the detection of pathological lymph nodes in women with ovarian cancer with the use of magnetic resonance imaging (MRI) combined with diffusion weighted MRI (DW-MRI) and contrast enhanced MRI (CE-MRI) with gadofosveset (Ablavar™). ;Secondary Objective: PThe secondary objectives are to compare the accuracy of MRI with conventional CT imaging in a pilot study;Primary end point(s): In this pilot study the main objective is to determine the optimal imaging settings and feasibility of MRI combined with DW-MRI and gadofosveset (Ablavar™) CE-MRI in with advanced stage epithelial ovarian cancer. A statistical analysis will not be performed for the primary endpoint. ;Timepoint(s) of evaluation of this end point: After administration of the contrast agent Ablavar, MRI images will be made and these will be evaluated within 7 days after the MRI scan.

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Secondary

Measure	Time frame
Secondary end point(s): Secundary study parameters are the diagnostic performance of CT and MRI. The sample size of the study will be insufficient to show a statistical difference between conventional CT and MRI (+/- diffusion and contrast enhancement). Nevertheless, sensitivity, specificity, negative and positive predictive value for the detection of metastatic lymph nodes will be calculated for MRI and compared with conventional CT. ;Timepoint(s) of evaluation of this end point: Within 3 months after gathering the data.	—

Measure

Time frame

Secondary end point(s): Secundary study parameters are the diagnostic performance of CT and MRI. The sample size of the study will be insufficient to show a statistical difference between conventional CT and MRI (+/- diffusion and contrast enhancement). Nevertheless, sensitivity, specificity, negative and positive predictive value for the detection of metastatic lymph nodes will be calculated for MRI and compared with conventional CT. ;Timepoint(s) of evaluation of this end point: Within 3 months after gathering the data.

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Countries

Netherlands

Contacts

Public ContactDivison Gynaecology/Oncology

Maastricht University Medical Centre

31433874767

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026