Randomised trial of LightPath Imaging in breast cancer surgery
| ISRCTN | ISRCTN17778965 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17778965 |
| ClinicalTrials.gov number | NCT02666079 |
| Secondary identifying numbers | LPM-007 |
- 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
Contact information
Dr Sheryl O'Farrell
Public
Public
Lightpoint Medical Ltd
First Floor, The Island
Moor Road
Chesham
HP5 1NZ
United Kingdom
| Phone | +44 7884 112654 |
|---|---|
| sheryl.ofarrell@lightpointmedical.com |
Study information
| Study design | Prospective randomised controlled multi-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a 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 hypothesis | 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 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 25/01/2016 |
| Overall study end date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 442 |
| Total final enrolment | 66 |
| 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 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
- England
- Germany
- United Kingdom
- Wales
Study participating centres
St Thomas' Hospital
Westminster Bridge Road
London
SE1 9RT
United Kingdom
London
SE1 9RT
United Kingdom
Southmead Hospital
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
University Hospital Llandough
Penlan Road
Llandough
CF64 2XX
United Kingdom
Llandough
CF64 2XX
United Kingdom
Royal Liverpool University Hospital
Prescot Street
Liverpool
L7 8XP
United Kingdom
Liverpool
L7 8XP
United Kingdom
Royal Surrey County Hospital
Egerton Road
Guildford
GU2 7XX
United Kingdom
Guildford
GU2 7XX
United Kingdom
Queen Alexandra Hospital
Southwick Hill Road
Portsmouth
PO6 3LY
United Kingdom
Portsmouth
PO6 3LY
United Kingdom
Kliniken Essen-Mitte
Henricistraße 92
Essen
45136
Germany
Essen
45136
Germany
Sponsor information
Lightpoint Medical Ltd
Industry
Industry
First Floor, The Island
Moor Road
Chesham
HP5 1NZ
United Kingdom
| Website | http://www.lightpointmedical.com/ |
|---|---|
"ROR" |
https://ror.org/04zym2g32 |
Funders
Funder type
Government
European Commission, Horizon 2020, Executive Agency for Small & Medium-sized Enterprises
No information available
Lightpoint Medical Ltd
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| 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. |
| 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 |
| Plain English results | 05/05/2022 | No | Yes | ||
| HRA research summary | 28/06/2023 | No | No |
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.
