Wide local excision (WLE) for breast cancer MedDRA version: 20.0 Level: HLT Classification code 10006290 Term: Breast and nipple neoplasms malignant System Organ Class: 100000004864
Conditions
Interventions
Product Name: 68Ga-RM2
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not yet available
CAS Number: 1444870-03-4
Current Sponsor code: Ga-RM2
Concentration unit: MBq megabecquerel(s
Sponsors
Lightpoint Medical Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): Agreement between margin status determined by LightPath Imaging and post-operative histopathology (Group 3);Timepoint(s) of evaluation of this end point: Once all patients have completed their follow-up visits | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;Timepoint(s) of evaluation of this end point: Once all patients have completed their follow up visit | — |
Countries
United Kingdom
Contacts
Public ContactProject Management
Lightpoint Medical Ltd
Outcome results
None listed