- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02666079
The LightPath® Breast Cancer Study
A Multi-centre Clinical Study to Evaluate the LightPath® Imaging System in Wide Local Excision (WLE) for Breast Cancer
This study is a prospective, single arm, multi-centre study to evaluate the intra-operative use of the LightPath® Imaging System for the assessment of tumour margin status compared to hospital standard of care histopathology in wide local excision (WLE) for breast cancer
The intraoperative 18F-fluorodeoxyglucose (18F-FDG) LightPath® Images will be used to inform the surgeons about detectable residual cancer, in an attempt to achieve better guided cancer surgery and complete tumour excision with clear WLE resection margins.
Study sites will use the local criteria considered standard of care to guide decisions to act on positive margins.
In the LightPath® arm the resection margin status of the WLE specimen, cavity shavings (if any) and the metastatic status of axillary (sentinel) lymph nodes as measured with the LightPath® Imaging System will be compared with histopathology results.
Study Overview
Detailed Description
Female subjects with a diagnosis of invasive breast cancer scheduled to have wide local excision (WLE) +/- sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be screened and receive 18F-FDG plus LightPath® Image. Subjects will have standard of care WLE. Extra cavity shaving due to positive 18F-FDG LightPath® Images is at the discretion of the surgeon.
Subjects will receive an intravenous injection of up to 5 MBq/kg, to a maximum 300 MegaBecquerel (MBq) of 18F-FDG prior to surgery.
Following resection, the WLE specimen will be examined using the LightPath® Imaging System. If the surgeons detect a positive signal they may perform cavity shavings of the resection cavity area corresponding to the positive signal area (up to a maximum thickness of 10mm).
Axillary SLNB will be performed according to local practice. At sites where 99mTc is used: In the 18F-FDG + LightPath® a higher dose of up to 150 MBq technetium-99m (99mTc) nanocolloid is necessary to avoid 18F-FDG masking the signal from 99mTc. Blue dye will be used according to local practice at sites where it is considered standard of care.
Sentinel lymph nodes (SLNs) will be examined using the LightPath® Imaging System. Where clinically indicated, ALND will be performed as per standard of care. At the time this protocol was finalised, LightPath® data involved lymph nodes sufficient to support recommendations were not available. For this reason, LightPath® Image results will not be used to direct ALND.
All LightPath® Images will be performed between 60 and 180 minutes post injection of 18F-FDG.
The WLE specimen, cavity shavings (where performed) and SLNs (where performed) will then undergo standard of care histopathological analysis. Lymph nodes will also be examined according to standard of care histopathological analysis. The results of the histopathological analysis will then be correlated with the LightPath® Images.
All staff in the operating room will wear badge dosimeters. Staff handling surgical specimens in theatre will also wear ring dosimeters. Histopathology analyses should be delayed to allow for radioactive decay of tissue samples to suitably low levels.
Subjects will be evaluated at screening and enrolment into the study. Data will be collected until the decision by the study site's MDT to recommend re-excision or mastectomy because of a positive margin on histopathological analysis (approx. 1-6 weeks post surgery)
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Qamar B Akbar
- Phone Number: +44 (0) 1494 917 697
- Email: qamar.akbar@lightpointmedical.com
Study Locations
-
-
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Gliwice, Poland, 44-101
- Recruiting
- Klinika Chirurgii Onkologicznej i Rekonstrukcyjnej Centrum Onkologii- Instytut oddział w Gliwicach, ul. Wybrzeże Armii Krajowej 15,
-
Contact:
- Maria Turska-d'Amico, MD
-
Kraków, Poland, 31-501
- Recruiting
- Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Endokrynologii, ul. Mikołaja Kopernika 17,
-
Contact:
- Anna Sowa-Staszczak, MD, PhD
-
Warszawa, Poland, 02-781
- Recruiting
- Centrum Onkologii - Instytut, im Marii Skłodowskiej-Curie, Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej ul. Roetgena 5
-
Contact:
- Prof. Zbigniew Nowecki, MD, PhD
-
-
-
-
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Liverpool, United Kingdom, L7 8XP
- Terminated
- Royal Liverpool Hospital
-
Llandough, United Kingdom, CF64 2XX
- Active, not recruiting
- Cardiff Breast Centre, LLandough Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 participants ≥18 years of age with a diagnosis of invasive breast cancer
- Subjects who have disease in one quadrant of the breast, not including the nipple
- Subjects scheduled for WLE for breast cancer +/- SLNB or ALND.
- Females of childbearing age must have a negative pregnancy test (by Beta human chorionic gonadotropin (HCG) qualitative analysis), or must have had a history of a surgical sterilisation, or must give history of no menses in the past twelve months
Exclusion Criteria:
- Subjects with pure DCIS or with pleomorphic LCIS
- Subjects who have had surgery in the ipsilateral breast in the past 12 months
- Subjects who have had radiotherapy in the ipsilateral breast
- Subjects who have had neoadjuvant systemic therapy
- Subjects who have had systemic chemotherapy in the past two years
- Subjects with a non-palpable lesion scheduled to have radio guided occult lesion localisation (ROLL)
- Subjects who have known hypersensitivity to 18F-FDG
- Subjects who are pregnant or lactating
- Subjects who have an existing medical condition that would compromise their participation in the study
- Subjects who have participated in a clinical study in the last 2 months
- Subjects with a current or active history of other known cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment arm
Wide local excision (WLE) for breast cancer with intra-operative use of the LightPath® Imaging System.
|
Intra-operative use of the LightPath® Imaging System.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic performance of the LightPath® Imaging System
Time Frame: Initial surgery
|
The diagnostic performance of tumour margin assessment with the LightPath® Imaging System compared to hospital histopathology.
|
Initial surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The recommendation by the study site's multidisciplinary team (MDT) to re-operate at the index location (breast) within 1 to 6 weeks post-initial surgery according to local practice.
Time Frame: 1-6 weeks post initial surgery
|
MDT recommendation for the subject to undergo re-excision or mastectomy because of a positive margin on histopathological analysis.
|
1-6 weeks post initial surgery
|
Rate of re-operation at the index location
Time Frame: 1 to 6 weeks post initial surgery
|
The number of subjects undergoing re-operation at the index location because of a positive margin on histopathological analysis, compared to published data on re-operation rates.
|
1 to 6 weeks post initial surgery
|
Volume of tissue excised
Time Frame: Initial surgery
|
Weight (g) of all fresh pieces of tissue removed
|
Initial surgery
|
Radiation dosimetry
Time Frame: Initial surgery
|
Dosimetry readings will be summarised by staff member and procedure
|
Initial surgery
|
Safety - adverse events (related to breast surgery)
Time Frame: Initial surgery
|
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether r not related to the device
|
Initial surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Agreement between LightPath® Image for lymph nodes status and histology
Time Frame: Initial surgery
|
Proportion of lymph nodes that agree metastatic status
|
Initial surgery
|
Biomarkers ER/PR/HER2 status
Time Frame: Screening
|
ER/PR/HER2 will each be defined as positive or negative in accordance with local practice
|
Screening
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Qamar B Akbar, MSc, Clinical Project Manager
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LPM-007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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