Breast CancerNCT02666079
The LightPath® Breast Cancer Study
A study testing LightPath® Imaging System. in people with Breast Cancer, run by Lightpoint Medical Limited at 5 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- LightPath® Imaging System.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 May 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Poland3 sites, 3 recruiting
- Recruiting
Klinika Chirurgii Onkologicznej i Rekonstrukcyjnej Centrum Onkologii- Instytut oddział w Gliwicach, ul. Wybrzeże Armii Krajowej 15,
Gliwice, 44-101
Maria Turska-d'Amico, MD
- Recruiting
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Endokrynologii, ul. Mikołaja Kopernika 17,
Krakow, 31-501
Anna Sowa-Staszczak, MD, PhD
- Recruiting
Centrum Onkologii - Instytut, im Marii Skłodowskiej-Curie, Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej ul. Roetgena 5
Warsaw, 02-781
Prof. Zbigniew Nowecki, MD, PhD
United Kingdom2 sites
- Terminated
Royal Liverpool Hospital
Liverpool, L7 8XP
- Active, not recruiting
Cardiff Breast Centre, LLandough Hospital
Llandough, CF64 2XX
About this study
Official title: A Multi-centre Clinical Study to Evaluate the LightPath® Imaging System in Wide Local Excision (WLE) for Breast Cancer
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.
Read more
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.
Read the detailed description
Female subjects with a diagnosis of invasive breast cancer scheduled to have wide local excision (WLE) +/- sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be screened and receive 18F-FDG plus LightPath® Image. Subjects will have standard of care WLE. Extra cavity shaving due to positive 18F-FDG LightPath® Images is at the discretion of the surgeon.
Subjects will receive an intravenous injection of up to 5 MBq/kg, to a maximum 300 MegaBecquerel (MBq) of 18F-FDG prior to surgery.
Following resection, the WLE specimen will be examined using the LightPath® Imaging System. If the surgeons detect a positive signal they may perform 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. At sites where 99mTc is used: In the 18F-FDG + LightPath® a higher dose of up to 150 MBq technetium-99m (99mTc) nanocolloid is necessary to avoid 18F-FDG masking the signal from 99mTc. Blue dye will be used according to local practice at sites where it is considered standard of care.
Sentinel lymph nodes (SLNs) will be examined using the LightPath® Imaging System. Where clinically indicated, ALND will be performed as per standard of care. At the time this protocol was finalised, LightPath® data involved lymph nodes sufficient to support recommendations were not available. For this reason, LightPath® Image results will not be used to direct ALND.
All LightPath® Images will be performed between 60 and 180 minutes post injection of 18F-FDG.
The WLE specimen, cavity shavings (where performed) and SLNs (where performed) will then undergo standard of care histopathological analysis. Lymph nodes will also be examined according to standard of care histopathological analysis. The results of the histopathological analysis will then be correlated with the LightPath® Images.
All staff in the operating room will wear badge dosimeters. Staff handling surgical specimens in theatre will also wear ring dosimeters. Histopathology analyses should be delayed to allow for radioactive decay of tissue samples to suitably low levels.
Subjects will be evaluated at screening and enrolment into the study. Data will be collected until the decision by the study site's MDT to recommend re-excision or mastectomy because of a positive margin on histopathological analysis (approx. 1-6 weeks post surgery)
- Conditions
- Breast Cancer
- Being tested
- LightPath® Imaging System.
- Keywords
- Wide local excision (WLE) for breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LightPath® Imaging System.Device
Intra-operative use of the LightPath® Imaging System.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Wide local excision (WLE) for breast cancer with intra-operative use of the LightPath® Imaging System. Receives: Device: LightPath® Imaging System. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of the LightPath® Imaging System
The diagnostic performance of tumour margin assessment with the LightPath® Imaging System compared to hospital histopathology.
Measured: 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.
MDT recommendation for the subject to undergo re-excision or mastectomy because of a positive margin on histopathological analysis.
Measured: 1-6 weeks post initial surgery
Rate of re-operation at the index location
The number of subjects undergoing re-operation at the index location because of a positive margin on histopathological analysis, compared to published data on re-operation rates.
Measured: 1 to 6 weeks post initial surgery
Volume of tissue excised
Weight (g) of all fresh pieces of tissue removed
Measured: Initial surgery
Radiation dosimetry
Dosimetry readings will be summarised by staff member and procedure
Measured: Initial surgery
Safety - adverse events (related to breast surgery)
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether r not related to the device
Measured: Initial surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study start1 May 2017
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lightpoint Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- Qamar B Akbar, MSc, Study director, Clinical Project Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666079
- Sponsor's protocol ID
- LPM-007
- Status last verified
- Jun 2018
- First submitted
- 25 Jan 2016
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33738563
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Clinical Study to Evaluate the LightPath® Imaging System in Wide Local Excision (WLE) for Breast Cancer
- ClinicalTrials.gov ID
- NCT02666079
- Acronym / sponsor ID
- LPM-007
- Conditions
- Breast Cancer
- Keywords
- Wide local excision (WLE) for breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Lightpoint Medical LimitedIndustry (pharma, biotech, devices)
- Collaborators
- European Commission
- Study start
- 1 May 2017 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Female subjects with a diagnosis of invasive breast cancer scheduled to have wide local excision (WLE) +/- sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) will be screened and receive 18F-FDG plus LightPath® Image. Subjects will have standard of care WLE. Extra cavity shaving due to positive 18F-FDG LightPath® Images is at the discretion of the surgeon.
Subjects will receive an intravenous injection of up to 5 MBq/kg, to a maximum 300 MegaBecquerel (MBq) of 18F-FDG prior to surgery.
Following resection, the WLE specimen will be examined using the LightPath® Imaging System. If the surgeons detect a positive signal they may perform 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. At sites where 99mTc is used: In the 18F-FDG + LightPath® a higher dose of up to 150 MBq technetium-99m (99mTc) nanocolloid is necessary to avoid 18F-FDG masking the signal from 99mTc. Blue dye will be used according to local practice at sites where it is considered standard of care.
Sentinel lymph nodes (SLNs) will be examined using the LightPath® Imaging System. Where clinically indicated, ALND will be performed as per standard of care. At the time this protocol was finalised, LightPath® data involved lymph nodes sufficient to support recommendations were not available. For this reason, LightPath® Image results will not be used to direct ALND.
All LightPath® Images will be performed between 60 and 180 minutes post injection of 18F-FDG.
The WLE specimen, cavity shavings (where performed) and SLNs (where performed) will then undergo standard of care histopathological analysis. Lymph nodes will also be examined according to standard of care histopathological analysis. The results of the histopathological analysis will then be correlated with the LightPath® Images.
All staff in the operating room will wear badge dosimeters. Staff handling surgical specimens in theatre will also wear ring dosimeters. Histopathology analyses should be delayed to allow for radioactive decay of tissue samples to suitably low levels.
Subjects will be evaluated at screening and enrolment into the study. Data will be collected until the decision by the study site's MDT to recommend re-excision or mastectomy because of a positive margin on histopathological analysis (approx. 1-6 weeks post surgery)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: LightPath® Imaging System.Wide local excision (WLE) for breast cancer with intra-operative use of the LightPath® Imaging System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LightPath® Imaging System.Intra-operative use of the LightPath® Imaging System. | Device | Treatment arm |
Primary outcome
Diagnostic performance of the LightPath® Imaging System
Time frame: Initial surgery
The diagnostic performance of tumour margin assessment with the LightPath® Imaging System compared to hospital histopathology.
5 secondary outcomes
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.
Time frame: 1-6 weeks post initial surgery
Rate of re-operation at the index location
Time frame: 1 to 6 weeks post initial surgery
Volume of tissue excised
Time frame: Initial surgery
Radiation dosimetry
Time frame: Initial surgery
Safety - adverse events (related to breast surgery)
Time frame: Initial surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Derived from this study: PubMed 33738563Jurrius 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.
- Company website with description of the technology and Conformité Européenne (CE) marked medical deviceLink provided by the sponsor.
- ISRCTN17778965Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qamar B Akbar, MSc study director
Clinical Project Manager
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LightPath® Imaging System. in people with Breast Cancer, run by Lightpoint Medical Limited at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qamar B Akbar (+44 (0) 1494 917 697, qamar.akbar@lightpointmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of the LightPath® Imaging System (time frame: Initial surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02666079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.