Randomised trial of LightPath Imaging in breast cancer surgery

ISRCTN	ISRCTN17778965
DOI	https://doi.org/10.1186/ISRCTN17778965
ClinicalTrials.gov (NCT)	NCT02666079
Protocol serial number	LPM-007
Sponsor	Lightpoint Medical Ltd
Funders	European Commission, Horizon 2020, Executive Agency for Small & Medium-sized Enterprises, Lightpoint Medical Ltd

Submission date: 25/01/2016
Registration date: 11/02/2016
Last edited: 05/05/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-the-use-of-the-lightpath-imaging-system-during-breast-surgery-lpm-007

Contact information

Dr Sheryl O'Farrell
Public

Lightpoint Medical Ltd
First Floor, The Island
Moor Road
Chesham
HP5 1NZ
United Kingdom

Phone	+44 7884 112654
Email	sheryl.ofarrell@lightpointmedical.com

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled multi-centre study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	Use of the LightPath™ Imaging System will reduce the rate of re-operations compared to standard of care surgery.
Ethics approval(s)	London – Dulwich Research Ethics Committee, 04/04/2016, ref: 16/LO/0414 Amendment 1: 13/06/2016 Amendment 2: 28/07/2016
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	442
Total final enrolment	66
Key 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
Key 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
Date of first enrolment	01/10/2016
Date of final enrolment	31/12/2017

Locations

Countries of recruitment

United Kingdom
England
Wales
Germany

Study participating centres

St Thomas' Hospital

Westminster Bridge Road
London
SE1 9RT
United Kingdom

Southmead Hospital

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

University Hospital Llandough

Penlan Road
Llandough
CF64 2XX
United Kingdom

Royal Liverpool University Hospital

Prescot Street
Liverpool
L7 8XP
United Kingdom

Royal Surrey County Hospital

Egerton Road
Guildford
GU2 7XX
United Kingdom

Queen Alexandra Hospital

Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom

Kliniken Essen-Mitte

Henricistraße 92
Essen
45136
Germany

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in repository
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	pilot study results	18/03/2021	22/03/2021	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			05/05/2022	No	Yes

Editorial Notes

05/05/2022: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
22/03/2021: Publication reference added.
22/09/2017: Internal review.
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.