A review of the LightPath Imaging System using the tracer 68Ga-RM2 in helping to show the boundaries of the breast cancer during removal of the tumour.

Phase 1

• Conditions: Wide local excision (WLE) for breast cancer; MedDRA version: 20.0Level: HLTClassification code 10006290Term: Breast and nipple neoplasms malignantSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-003212-39-GB
• Lead Sponsor: ightpoint Medical Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-29
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to examine the performance of the LightPath Imaging<br>System using the PET tracer 68Ga-RM2 in 3 sequential groups of patients scheduled<br>for and/or undergoing wide local excision (WLE) for breast cancer with an ERpositive<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): Group 1 only<br>- Optimal scan time-window for 68Ga-RM2 PET/CT imaging<br>- Gamma probe measurements (collimated) in the axilla to determine optimal 68Ga-RM2 activity<br>- Diagnostic value of 68Ga-RM2 PET/CT imaging for breast cancer staging<br>- Radiation dosimetry measurements for the staff<br><br>Group 2 only<br>- Optimal device settings, tracer dose, and working procedures<br><br>Group 3 only<br>- 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