E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diagnosis of lymph node metastases in patients with newly diagnosed breast cancer. |
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E.1.1.1 | Medical condition in easily understood language |
Diagnosing whether cancer cells have spread to the lymph nodes (glands) in the axilla (armpit) of patients with newly diagnosed breast cancer. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057654 |
E.1.2 | Term | Breast cancer female |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006203 |
E.1.2 | Term | Breast cancer stage unspecified |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
To see if using an ultrasound visible "dye" (microbubble) to detect the sentinel lymph node draining the breast and to comprehensively biopsy the node once identified can significantly improve the pre-operative diagnosis of axillary (armpit) lymph gland (node) cancer deposits in patients with breast cancer. |
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E.2.2 | Secondary objectives of the trial |
To determine the percentage of patients whose nodes could be identified with ultrasound visible "dye" (microbubble). To determine the percentage of patients whose nodes could be identified with ultrasound visible "dye" (microbubble) who then underwent successful comprehensive biopsy using a vacuum assisted biopsy device.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To be included in the study the patients must:
- aged 18 years or over - have biopsy proven invasive breast cancer - have SLN biopsy recommended as part of their standard surgical management for breast cancer - be able to give written informed consent |
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E.4 | Principal exclusion criteria |
The presence of any of the following will preclude patient inclusion:
- unable to provide written informed consent - aged 17 years or under - history of previous ipsilateral breast cancer - prior ipsilateral axillary surgery - pregnant or lactating women
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure is the incidence of lymph node metastases diagnosed on pre-operative biopsy using the microbubble guided biopsy technique. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Analysis will take place at the end of the study. Patients will undergo an intradermal injection of Sulphur Hexafluoride and the contrast will be traced to the axilla and the first draining SLN will be identified. The identified SLN will then be comprehensively biopsied with the aim of removing the identified node. Any patient without metastatic deposits will proceed to SLNB as before. Any patient whose lymph node reveals metastases will not require an SLNB and may proceed directly to surgical excision of all their remaining axillary lymph nodes. The findings in patients undergoing successful percutaneous biopsy will be compared with final surgical histology whether SLNB or ALND. The improvement in the pre-operative diagnosis rate using this technique can then be calculated. |
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E.5.2 | Secondary end point(s) |
To determine the percentage of patients whose nodes could be identified with Sulphur Hexafluoride. To determine the percentage of patients whose nodes could be identified with Sulphur Hexafluoride who underwent successful vacuum assisted biopsy.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
As with the primary endpoints analysis will take place at the end of the study. |
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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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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
| 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 | 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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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 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
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 |