The LightPath® Breast Cancer Study

NCT02666079 | Unknown

• 1 other identifier: LPM-007
• Study Type: interventional
• Target: 170
• Locations: 2 countries
• Sites: 5

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.

Conditions

Breast Cancer

Keywords

Wide local excision (WLE) for breast cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of the LightPath® Imaging System

  The diagnostic performance of tumour margin assessment with the LightPath® Imaging System compared to hospital histopathology.

  Initial surgery

Secondary Outcomes (5)

• 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.

  1-6 weeks post initial surgery

• Rate of re-operation at the index location

  1 to 6 weeks post initial surgery

• Volume of tissue excised

  Initial surgery

• Radiation dosimetry

  Initial surgery

• Safety - adverse events (related to breast surgery)

  Initial surgery

Other Outcomes (2)

• Agreement between LightPath® Image for lymph nodes status and histology

  Initial surgery

• Biomarkers ER/PR/HER2 status

  Screening

Study Arms (1)

Treatment arm

EXPERIMENTAL

Wide local excision (WLE) for breast cancer with intra-operative use of the LightPath® Imaging System.

Device: LightPath® Imaging System.

Interventions

LightPath® Imaging System. DEVICE

Intra-operative use of the LightPath® Imaging System.

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lightpoint Medical Limited: lead
• European Commission: collaborator

Study Sites (5)

Klinika Chirurgii Onkologicznej i Rekonstrukcyjnej Centrum Onkologii- Instytut oddział w Gliwicach, ul. Wybrzeże Armii Krajowej 15,

Gliwice, 44-101, Poland

RECRUITING

Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Endokrynologii, ul. Mikołaja Kopernika 17,

Krakow, 31-501, Poland

RECRUITING

Centrum Onkologii - Instytut, im Marii Skłodowskiej-Curie, Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej ul. Roetgena 5

Warsaw, 02-781, Poland

RECRUITING

Royal Liverpool Hospital

Liverpool, L7 8XP, United Kingdom

TERMINATED

Cardiff Breast Centre, LLandough Hospital

Llandough, CF64 2XX, United Kingdom

ACTIVE NOT RECRUITING

Related Publications (1)

• Jurrius PAGT, Grootendorst MR, Krotewicz M, Cariati M, Kothari A, Patani N, Karcz P, Nagadowska M, Vyas KN, Purushotham A, Turska-d'Amico M. Intraoperative [18F]FDG flexible autoradiography for tumour margin assessment in breast-conserving surgery: a first-in-human multicentre feasibility study. EJNMMI Res. 2021 Mar 18;11(1):28. doi: 10.1186/s13550-021-00759-w.

  PMID: 33738563 DERIVED

Related Links

• Company website with description of the technology and Conformité Européenne (CE) marked medical device
• ISRCTN17778965

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Qamar B Akbar, MSc

  Clinical Project Manager

  STUDY DIRECTOR

Central Study Contacts

Qamar B Akbar

CONTACT

+44 (0) 1494 917 697; qamar.akbar@lightpointmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: January 28, 2016
• Study Start: May 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 20, 2018

Record last verified: 2018-06

Locations

PL (3); GB (2)