E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Wide local excision (WLE) for breast cancer |
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E.1.1.1 | Medical condition in easily understood language |
Removal of breast cancer tumour |
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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 | 20.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10006290 |
E.1.2 | Term | Breast and nipple neoplasms malignant |
E.1.2 | System Organ Class | 100000004864 |
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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 |
The objective of this study is to examine the performance of the LightPath Imaging
System using the PET tracer 68Ga-RM2 in 3 sequential groups of patients scheduled
for and/or undergoing wide local excision (WLE) for breast cancer with an ERpositive
invasive primary cancer. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects who have signed an informed consent form prior to any study related activity
Subjects who are able to give voluntary, written informed consent to participate in this study.
Subjects who are able to understand this study and are willing to complete all the study assessments
Female subjects ≥18 years of age with a diagnosis of ER-positive invasive breast cancer. ER-positivity is defined as an Allred score of 3 or more on immunohistochemical analysis.
Female subjects of childbearing age must have a negative pregnancy test (by Beta human chorionic gonadotrophin qualitative analysis), or must have had a history of a surgical sterilisation, or must give history of no menses in the past twelve months
Groups 2 and 3: Subjects scheduled for WLE (+/- SLNB or ALND)
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E.4 | Principal exclusion criteria |
Subjects who have had surgery in the operated breast in the past 12 months
Subjects who have had radiotherapy in the operated breast
Subjects who have had neoadjuvant systemic therapy
Subjects who have had systemic chemotherapy or investigational therapy in the past two years
Subjects who are pregnant or lactating
Subjects who have an existing medical condition that would compromise their participation in the study
Subjects with a current or active history of other known cancer in the opinion of the Investigator
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E.5 End points |
E.5.1 | Primary end point(s) |
Agreement between margin status determined by LightPath Imaging and post-operative histopathology (Group 3) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Once all patients have completed their follow-up visits |
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E.5.2 | Secondary end point(s) |
Group 1 only
- Optimal scan time-window for 68Ga-RM2 PET/CT imaging
- Gamma probe measurements (collimated) in the axilla to determine optimal 68Ga-RM2 activity
- Diagnostic value of 68Ga-RM2 PET/CT imaging for breast cancer staging
- Radiation dosimetry measurements for the staff
Group 2 only
- Optimal device settings, tracer dose, and working procedures
Group 3 only
- Inter-rater agreement in post-operative standardised, controlled assessments of LightPath Images |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Once all patients have completed their follow up visit |
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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 | Yes |
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) | Yes |
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 | Yes |
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.8.2.4 | Number of treatment arms in the trial | 3 |
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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Recruitment will continue until 80 participants have been assessed as planned in the sequential groups, irrespective of surgical procedures completed |
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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 | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |