Magnetic resonance Imaging for Lymph node staging in Ovarian cancer

Phase 1

• Conditions: Ovarian Cancer - diagnosis of lymph nodes; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2014-001619-37-NL
• Lead Sponsor: Maastricht University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-03
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 20

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

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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. <br>;Timepoint(s) of evaluation of this end point: Within 3 months after gathering the data.