The LightPath® Breast Cancer Study
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|ClinicalTrials.gov Identifier: NCT02666079|
Recruitment Status : Recruiting
First Posted : January 28, 2016
Last Update Posted : June 20, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: LightPath® Imaging System.||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-centre Clinical Study to Evaluate the LightPath® Imaging System in Wide Local Excision (WLE) for Breast Cancer|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Treatment arm
Wide local excision (WLE) for breast cancer with intra-operative use of the LightPath® Imaging System.
Device: LightPath® Imaging System.
Intra-operative use of the LightPath® Imaging System.
- 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.
- 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.
- 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.
- Volume of tissue excised [ Time Frame: Initial surgery ]Weight (g) of all fresh pieces of tissue removed
- Radiation dosimetry [ Time Frame: Initial surgery ]Dosimetry readings will be summarised by staff member and procedure
- 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
- Agreement between LightPath® Image for lymph nodes status and histology [ Time Frame: Initial surgery ]Proportion of lymph nodes that agree metastatic status
- Biomarkers ER/PR/HER2 status [ Time Frame: Screening ]ER/PR/HER2 will each be defined as positive or negative in accordance with local practice
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666079
|Contact: Qamar B Akbar||+44 (0) 1494 917 email@example.com|
|Klinika Chirurgii Onkologicznej i Rekonstrukcyjnej Centrum Onkologii- Instytut oddział w Gliwicach, ul. Wybrzeże Armii Krajowej 15,||Recruiting|
|Gliwice, Poland, 44-101|
|Contact: Maria Turska-d'Amico, MD|
|Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Endokrynologii, ul. Mikołaja Kopernika 17,||Recruiting|
|Kraków, Poland, 31-501|
|Contact: Anna Sowa-Staszczak, MD, PhD|
|Centrum Onkologii - Instytut, im Marii Skłodowskiej-Curie, Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej ul. Roetgena 5||Recruiting|
|Warszawa, Poland, 02-781|
|Contact: Prof. Zbigniew Nowecki, MD, PhD|
|Royal Liverpool Hospital||Terminated|
|Liverpool, United Kingdom, L7 8XP|
|Cardiff Breast Centre, LLandough Hospital||Active, not recruiting|
|Llandough, United Kingdom, CF64 2XX|
|Study Director:||Qamar B Akbar, MSc||Clinical Project Manager|