E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The presence of axillary metastasis in patients with proven invasive breast cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006188 |
E.1.2 | Term | Breast cancer female NOS |
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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 |
Uspio enhanced MRI (MRL) has the ability to show all lymph nodes and hence provide information on metastasis in all nodes, in contrast with SLNB which only provides information on 1 lymph node. With MRL metastases down to a size of 1 mm are detected. In 38% to 62% of patients with a positive sentinel lymph node (SLN), the SLN is the only positive node. ALND is performed in all these women and only afterwards judged unnecessary. We expect MRL to be able to identify women who have no (further) involvement of lymph nodes prior to SLNB or after a positive SLNB. Consequently ALND can be withheld from these women. MRL may also prove valuable in the 4% of patients where localisation of the SLN fails. Finally, because SLNB is false negative in 7-9% of patients, some patients are inadequately treated. MRL has a high sensitivity and provides information on all lymph nodes, consequently it may reduce the number of false negative SLNB findings.
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E.2.2 | Secondary objectives of the trial |
· Sensitivity on a node to node basis · Specificity, Accuracy, negative predictive value and positive predictive value on a patient to patient and node to node basis · Posttest probability negative rate · Feasibility of MRL after SLNB · Diagnostic accuracy of MRL after SLNB · Prognostic value of IMN involvement · Prognostic value of positive and negative MRL after positive SLNB followed by irradiation of the axilla · Feasibility of MRL after neoadjuvant chemotherapy · Diagnostic accuracy of MRL after neoadjuvant chemotherapy · Effect of chemotherapy on tumor positive axillary lymph nodes |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
nclusion criteria - Histologically proven invasive breast cancer - Surgical removal of at least 1 axillary lymph node will be performed - Patient must be accessible for treatment - Patient must provide written informed consent |
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E.4 | Principal exclusion criteria |
Exclusion criteria - Patient age under 18 - Karnofsky score equal to or under 70 - Pregnant or lactating women - Patients with conta-indications for MRI scanning (e.g. pacemaker, claustrophobia, ferromagnetic objects in the eyes or brain) - Patients with contra-indications for the use of USPIO based contrast agents or dextran (e.g. known allergy) - Male gender |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the sensitivity of MRL for proved lymph node involvement by histopathology on a patient to patient basis |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |