E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ovarian Cancer - diagnosis of lymph nodes |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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™). |
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E.2.2 | Secondary objectives of the trial |
PThe secondary objectives are to compare the accuracy of MRI with conventional CT imaging in a pilot study |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | 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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E.5.2 | 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Within 3 months after gathering the data. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Prospective pilot study (feasibility study). |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |