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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
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Lightpoint Medical Limited

Brief Summary:

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

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)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Volume of tissue excised [ Time Frame: Initial surgery ]
    Weight (g) of all fresh pieces of tissue removed

  4. Radiation dosimetry [ Time Frame: Initial surgery ]
    Dosimetry readings will be summarised by staff member and procedure

  5. 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


Other Outcome Measures:
  1. Agreement between LightPath® Image for lymph nodes status and histology [ Time Frame: Initial surgery ]
    Proportion of lymph nodes that agree metastatic status

  2. Biomarkers ER/PR/HER2 status [ Time Frame: Screening ]
    ER/PR/HER2 will each be defined as positive or negative in accordance with local practice



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

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


Contacts
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Contact: Qamar B Akbar +44 (0) 1494 917 697 qamar.akbar@lightpointmedical.com

Locations
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Poland
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         
United Kingdom
Royal Liverpool Hospital Terminated
Liverpool, United Kingdom, L7 8XP
Cardiff Breast Centre, LLandough Hospital Active, not recruiting
Llandough, United Kingdom, CF64 2XX
Sponsors and Collaborators
Lightpoint Medical Limited
European Commission
Investigators
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Study Director: Qamar B Akbar, MSc Clinical Project Manager

Additional Information:
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Responsible Party: Lightpoint Medical Limited
ClinicalTrials.gov Identifier: NCT02666079     History of Changes
Other Study ID Numbers: LPM-007
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lightpoint Medical Limited:
Wide local excision (WLE) for breast cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases