Condition category
Cancer
Date applied
25/01/2016
Date assigned
11/02/2016
Last edited
14/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Dr Sheryl O'Farrell

ORCID ID

Contact details

Lightpoint Medical Ltd
First Floor
The Island
Moor Road
Chesham
HP5 1NZ
United Kingdom
+44 7884 112654
sheryl.ofarrell@lightpointmedical.com

Additional identifiers

EudraCT number

N/A

ClinicalTrials.gov number

NCT02666079

Protocol/serial number

LPM-007

Study information

Scientific title

A randomised, controlled, multi-centre clinical study to evaluate the outcomes following the intra-operative use of the LightPathTM Imaging System compared to standard practice in wide local excision (WLE) for breast cancer

Acronym

Study hypothesis

Use of the LightPath™ Imaging System will reduce the rate of re-operations compared to standard of care surgery.

Ethics approval

London – Dulwich Research Ethics Committee, 04/04/2016, ref: 16/LO/0414
Amendment 1: 13/06/2016
Amendment 2: 28/07/2016

Study design

Prospective randomised controlled multi-centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Breast cancer

Intervention

Female participants with a diagnosis of invasive breast cancer or ductal carcinoma in situ (DCIS) scheduled to have wide local excision (WLE) +/- sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be screened, and if eligible randomised (1:1) to either: the 18F-FDG plus LightPath™ Imaging System arm (Treatment Arm) or the arm without 18F-FDG and LightPath™ (control arm).

Participants in both arms will have standard of care WLE of the primary tumour. Following resection, the WLE specimen, shavings (if any) and lymph nodes will be examined using the LightPath™ Imaging System (Treatment Arm only). If the surgeons detect a positive signal they may perform extra 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. Sentinel lymph nodes (SLNs) will be examined using the LightPath™ Imaging System (Treatment Arm only). Where clinically indicated, ALND will be performed as per standard of care. At the time this protocol was finalised LightPath™ data from involved lymph nodes sufficient to support recommendations were not available. For this reason, LightPath™ Image results will not be used to direct ALND.

The WLE surgery constitutes the total duration of treatment in this study. Following surgery, the study site’s multidisciplinary team (MDT) will decide whether or not to re-operate at the index location (breast). This is the study’s primary outcome, and according to local practice the decision is made between 1 and 12 weeks after surgery.

At study sites where long-term follow-up is standard of care participants will return for study follow-up visits at 1-12 weeks, 6 and 12 months after completion of the initially planned surgery. After this the participants will be followed up annually to 60 months after the initial surgery.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Primary outcome as of 30/08/2016:
Decision by the study site’s multidisciplinary team (MDT) to re-operate at index location (breast). Assessed within 1-6 weeks, according to local practice.

Original primary outcome:
Decision by the study site’s multidisciplinary team (MDT) to re-operate at index location (breast) assessed within 1-12 weeks, according to local practice

Secondary outcome measures

Secondary outcomes as of 30/08/2016:
1. Initial surgery (deviations on decision to re-operate, volume of tissue excised, complete surgical resection, normalised total tissue volume, duration of surgical operation)
2. Safety (adverse events)
3. Patient Outcomes (EORTC QLQ-C30, EORTC QLQ-C30, HADS and EQ-5D at screening, 3, 6, 12 and 24 months follow-up and cosmesis outcome)
4. Use of the LightPath™ Imaging System (Agreement between LightPath™ images and histology, Ease of Use Questionnaire, radiation safety, independent review of LightPath™ images)
5. Breast cancer (re-operation rate, time to recurrence, survival, overall survival, disease specific survival)

Original secondary outcomes:
1. Re-operation rate at index location, as directed by decision to re-operate and logistics
2. Volume of primary lump and lump plus shavings, data collected at initial surgery
3. Quality of Life (QoL) assessment including cosmetic assessment (at screening, 1-12 weeks, 6 months and 12 months)
4. In LightPath™ arm only: Radiation dosimetry on operating room and recovery area staff. Data collected at initial surgery
5. Proportion of LightPath™ Image positive margins that correlate with histology. Data collected at initial surgery
6. Proportion of LightPath™ Image positive shavings that correlate with histology. Data collected at initial surgery
7. In LightPath™ arm only: Ease-of use of LightPathTM system. Data collected on day of surgery
8. Re-intervention for residual tumour
9. Cosmesis based on quality of life (QoL) questionnaire (at screening, 1-12 weeks, 6 months and 12 months)
10. Lymph node involvement by LightPath™ Image (compared with histology: macrometastasis, micrometastasis, or isolated tumour cells). Data collected by 3 months after initial surgery
11. Number of patients with ipsilateral breast tumour recurrence (IBTR) during follow-up. Data collected by 3 months
12. Disease-free survival. Data collected by 3 months
13. In LightPath™ arm only: Study-related adverse events. Data collected by 3 months after initial surgery
14. Re-intervention costs/health economics. Re-intervention by +3 months post initial study surgery
15. Overall survival. Data collected by 3 months

Overall trial start date

25/01/2016

Overall trial end date

31/12/2022

Reason abandoned

Eligibility

Participant inclusion criteria

1. Signed an informed consent form prior to any study related activity
2. Able to give voluntary, written informed consent to participate in this study.
3. Able to understand this study and are willing to complete all the study assessments
4. Female subjects ≥18 years of age with a diagnosis of invasive breast cancer or DCIS
5. Those who have unifocal disease in one quadrant of the breast, not including the nipple
6. Those who have a tumour diameter of at least 10 mm (if measurable by mammography)
7. Scheduled for WLE +/- SLNB or ALND
8. Of childbearing age must have a negative pregnancy test (by Beta 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

442

Participant exclusion criteria

Subjects who:
1. Have had surgery in the operated breast in the past 2 years
2. Have had radiotherapy in the operated breast
3. Have had neoadjuvant systemic therapy
4. Have had systemic chemotherapy in the past two years
5. Not suitable for WLE
6. Have blood glucose level ≥12 mmol/L
7. Have known hypersensitivity to 18F-FDG
8. Planned perioperative or Intraoperative Radiation Therapy (IORT) or brachytherapy
9. Pregnant or lactating
10. Have an existing medical condition that would compromise their participation in the study
11. Have participated in a clinical study in the last 2 months
12. Current or active history of other known cancer

Recruitment start date

01/10/2016

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Germany, United Kingdom

Trial participating centre

St Thomas' Hospital
Westminster Bridge Road
London
SE1 9RT
United Kingdom

Trial participating centre

Southmead Hospital
Southmead Road Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Trial participating centre

University Hospital Llandough
Penlan Road
Llandough
CF64 2XX
United Kingdom

Trial participating centre

Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom

Trial participating centre

Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX
United Kingdom

Trial participating centre

Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom

Trial participating centre

Kliniken Essen-Mitte
Henricistraße 92
Essen
45136
Germany

Sponsor information

Organisation

Lightpoint Medical Ltd

Sponsor details

First Floor
The Island
Moor Road
Chesham
HP5 1NZ
United Kingdom

Sponsor type

Industry

Website

http://www.lightpointmedical.com/

Funders

Funder type

Government

Funder name

European Commission, Horizon 2020, Executive Agency for Small & Medium-sized Enterprises

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Lightpoint Medical Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The sponsor will register the study and post study results on publicly accessible websites (including www.ClinicalTrials.gov, www.isrctn.org). All data and results and all intellectual property rights in the data and results derived from the study will be the property of the sponsor, who may utilise the data in various ways, such as for submission to government regulatory authorities or disclosure to other Investigators.

The sponsor will ensure that both positive and negative results of the study will be published in scientific journals and/or trial registers or websites as required. The sponsor recognises the right of the participants to be informed about the study results and will take appropriate measures to inform any participant who wishes to know about the study results. Any manuscript or abstract produced by an investigator must be provided to the sponsor for review 30 days prior to submission. Individual participant identity cannot be divulged in any publication. Details of publications will be addressed in the Investigator Agreement.

Intention to publish date

31/12/2024

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/11/2016: Cancer Help UK lay summary link added. 19/09/2016: A German site has been added to the list of trial participating centres and the overall trial start date has been updated from 01/06/2016 to 25/01/2016. 30/08/2016: The target number of participants has been changed from 400 to 442 and the recruitment start date has been updated from 01/06/2016 to 01/10/2016. In addition, the trial participating centres and dates of ethical amendments have been added and the outcome measures have been updated. 13/07/2016: Internal review. 08/04/2016: Ethics approval information added. 31/03/2016: The study contact has been updated from Mr Morten Harboe to Dr Sheryl O'Farrell.