The Breast Surgery EnLight and LightPath Imaging System Study

NCT02151071 | Unknown Phase 1

• 1 other identifier: LPM-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will correlate the resection margin status of the breast cancer tumour (WLE specimen), cavity shavings (if any) and breast cavity, and the metastatic status of axillary lymph nodes as determined by EnLight, LightPath, and histopathology. This is a pilot study to assess feasibility before proceeding to a pivotal study to evaluate the use of these imaging systems in clinical practice.

Conditions

Breast Neoplasms

Keywords

Breast Cancer; Mastectomy, Segmental; Breast Conserving Surgery; Cerenkov Luminescence Imaging; Beta particle detection

Outcome Measures

Primary Outcomes (1)

• Feasibility of intraoperative use of the EnLight and LightPath Imaging Systems.

  The objective of this study is to assess the feasibility of the EnLight and LightPath Imaging Systems for intra-operative analysis of WLE specimens, the post-resection surgical cavity, shavings (if any) and axillary lymph nodes in vivo and ex vivo. This will be assessed by examining the following secondary outcome measures

  Intra-operative

Secondary Outcomes (1)

• Tumour margin status of the WLE specimen (and shavings, if any) as determined by LightPath

  Intra-operative

Other Outcomes (7)

• Tumour margin status of the WLE specimen (and shavings, if any) as determined by EnLight

  Intra-operatively

• Tumour margin status of the post-resection breast surgical cavity as determined by EnLight

  Intra-operatively

• In vivo metastatic status of axillary lymph nodes as determined by EnLight

  Intra-operatively

Study Arms (1)

Breast conserving surgery

OTHER

Females ≥ 30 years of age with a diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS), scheduled for BCS +/- SLNB or ALND

Device: EnLight; Device: LightPath

Interventions

EnLight DEVICE

The Lightpoint EnLight beta particle detector is an investigational non CE-marked medical device

Breast conserving surgery

LightPath DEVICE

The LightPath Imaging System is an investigational non CE-marked in vitro diagnostic device

Breast conserving surgery

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females ≥ 30 years of age with a diagnosis of invasive breast cancer or DCIS
• Scheduled for BCS +/- SLNB or ALND
• Females of childbearing age must have a negative pregnancy test (by Beta HCG qualitative analysis), must have a history of surgical sterilisation, or must give history of no menses in past twelve months

You may not qualify if:

• Surgery or radiotherapy in the operated breast in the past 2 years
• Neoadjuvant systemic therapy
• Patients not suitable for BCS
• Blood glucose level ≥ 12 mmol/l on the day of surgery
• Known hypersensitivity to 18F-FDG
• Any patient who is pregnant or lactating

Sponsors & Collaborators

• Lightpoint Medical Limited: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• King's College London: collaborator

Study Sites (1)

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Anand D Purushotham

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anand D Purushotham, MBBS FRCS MD

CONTACT

ea-purushotham@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: May 30, 2014
• Study Start: September 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2019
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

GB (1)