E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patient with breast cancer with an indication for sentinel lymph node biopsy |
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E.1.1.1 | Medical condition in easily understood language |
Patient with breast cancer with an indication for sentinel lymph node biopsy |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
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 |
To evaluate if microbubble-enhanced localization of the SLN, followed by I-125 seed placement, is an accurate tool for preoperative identification of the SLN in women with invasive or in situ breast cancer in terms of diagnostic accuracy, sensitivity and technical feasibility |
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E.2.2 | Secondary objectives of the trial |
To evaluate if microbubble-enhanced localization of the SLN, followed by I-125 seed placement, is superior to Tc-99m enhanced SLN biopsy in terms of patient comfort (pain), duration of procedure and preference of the surgeon and radiologist. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Females, aged 18 years or older;
- Histologically confirmed invasive carcinoma or patients with in situ breast cancer with indication for SLN biopsy;
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E.4 | Principal exclusion criteria |
- Male patients;
- Histologically or cytologically proven axillary lymph node involvement;
- Recurrent disease;
- Indication for ALND;
- Pregnancy or lactation;
- Sentinel lymph node biopsy after neoadjuvant treatment;
- Recent acute coronary syndrome or unstable ischemic heart disease*;
- Severe lung disease* and shortness of breath;
- Unstable neurologic disease, acute endocarditis, artificial heart valves, acute systemic infection, tromboembolic disease, advanced liver or kidney failure;
- Mentally incompetent patients.
* SonoVue is contraindicated in patients known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg, uncontrolled systemic hypertension, and in patients with adult respiratory distress syndrome. Caution is advised when SonoVue is administered to patients with clinically significant pulmonary disease, including severe chronic obstructive pulmonary disease. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Detection rate of microbubble-enhanced Iodine-125 seed localization of SLN, defined as the number of patients in whom the microbubble-enhanced SLN and the Tc-99m enhanced SNL are the same. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After completion of the trial |
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E.5.2 | Secondary end point(s) |
- Sensitivity of microbubble-enhanced I-125 seed localization: [number of patients with microbubble detected metastatic SLNs] / [total number of patients with axillary lymph node metastases].
- Technical feasible microbubble-enhanced I-125 seed localization of SLN: successful visualization of SLN, successful I-125 seed placement and excision of I-125 seed without migration or seed loss.
- Preoperative concordance of microbubble and Tc-99m enhanced SLNs, imaged with SPECT/CT.
- Duration of procedures and hospitalization.
- Patients pain and comfort scores: microbubble-enhanced versus Tc-99m guided localization of SLN.
- Surgeon’s / radiologists preferences and opinions.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After completion of the trial |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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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The end of the trial is the pathology examination of the surgical specimens of the last subject participating in 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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |