Breast CancerPhase 3NCT03731026
The LightPath® and 68Ga-RM2 in Breast Cancer Study
A Phase 3 study testing LightPath® Imaging System and 68Ga-RM2 and 68Ga-RM2 in people with Breast Cancer, run by Lightpoint Medical Limited at 1 site in United Kingdom.
Trial summary
This study is a prospective, open-label study to examine the performance of the LightPath® Imaging System using the PET tracer 68Ga-RM2 in patients scheduled for and/or undergoing wide local excision (WLE) with or without sentinel lymph node biopsy (SLNB) or complete axillary lymph node dissection(cALND) for breast… 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 and 68Ga-RM2 and 68Ga-RM2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Nov 2018to Nov 2023
- Phase
- Phase 3
- 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 subjects ≥18 years of age with a diagnosis of ER-positive invasive breast cancer. ER-positivity is defined as an Allred score of 3 or more on immunohistochemical analysis.
- Female subjects 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
- Groups 2 and 3: Subjects scheduled for WLE +/-SLNB or ALND
Who cannot join
- Subjects who have had surgery in the operated breast in the past 12months
- Subjects who have had radiotherapy in the operated breast
- Subjects who have had neoadjuvant systemic therapy
- Subjects who have had systemic chemotherapy or investigational therapy in the past two years
- Subjects who are pregnant or lactating
- Subjects who have a known hypersensitivity to 68Ga, bombesin analogues, or GRPR-antagonists
- Subjects who have an existing medical condition that would compromise their participation in the study•Subjects with a current or active history of other known cancerin the opinion of the Investigator
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
Arnand Purushotham, MD
About this study
Official title: Evaluation of the LightPath® Imaging System and the PET Tracer 68Ga-RM2 in Wide Local Excision (WLE) for Breast Cancer
This study is a prospective, open-label study to examine the performance of the LightPath® Imaging System using the PET tracer 68Ga-RM2 in patients scheduled for and/or undergoing wide local excision (WLE) with or without sentinel lymph node biopsy (SLNB) or complete axillary lymph node dissection(cALND) for breast cancer with an ER-positive invasive primary cancer.
The study consists of 3 sequential groups:
Read more
Group 1 (N=20 patients): Torso, i.e. base of skull to thighs, PET/CT imaging and axillary gamma probe measurements (using a collimator) of 68Ga-RM2 to: determine the optimal scan time-window post-injection; to extrapolate the optimal dose for resolution against axillary background signal on gamma probe measurements (first 6 patients); and the value of 68Ga-RM2 PET/CT imaging for breast cancer staging (all 20 patients).
Group 2 (N=10 patients): Intraoperative LightPath® imaging with 68Ga-RM2 to familiarise site with procedure and interpretation of intraoperative scans,validate the dose and timings determined from Group 1, and optimise LightPath® Imaging parameters such as acquisition resolution and duration. Group 2 scans will acquire LightPath® images of both intact and incised cancer specimens for post-operative standardised, controlled assessment. Group 2 will use the optimal scan time-window and 68Ga-RM2 activity extrapolated from at least the first 6 patients in Group 1. The dose of 68Ga-RM2 will be determined to optimise the intra-operative imaging and axillary gamma probe measurements.
Group 3 (N=50 patients): Intraoperative LightPath® imaging with 68Ga-RM2 to measure agreement between LightPath® images and post-operative histopathology. Group 3 scans will acquire LightPath® images of intact and incised cancer specimens for post-operative standardised, controlled assessment. Group 3 will use the optimal scan time-window and 68Ga-RM2 activity extrapolated from the first 6 patients in Group 1 with the optimised imaging parameters, and dose developed from Group 2.
The intraoperative 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
The study site will use the local criteria considered standard of care to guide decisions to act on positive margins. Lightpoint Medical will provide guidance to act on LightPath® Images in the Instructions forUse (IFU). It will be at the Investigator's discretion to choose whether to act based upon the intraoperative LightPath® Images.
In Group 3,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. A positive margin on histology will be defined as
- Invasive carcinoma: positive: ink on tumour; close: <1mm; negative ≥1mm
- Ductal carcinoma in situ (DCIS)or pleomorphic lobular carcinoma in situ (LCIS) (if present): positive: ink on tumour; close: <2mm; negative ≥2mm.
- Conditions
- Breast Cancer
- Being tested
- LightPath® Imaging System and 68Ga-RM2, 68Ga-RM2
- 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 and 68Ga-RM2Combination product
Imaging System:The LightPath® Imaging System is an in vitro diagnostic device which has CE mark in Europe, in line with In Vitro Diagnostic Medical Devices 98/79/EC (post-marketing study).
Radiopharmaceutical: 68Ga-RM2 is an investigational Positron Emission Tomography (PET)/ Computed Tomography (CT) radiopharmaceutical.
68Ga-RM2Drug
Radiopharmaceutical: 68Ga-RM2 is an investigational Positron Emission Tomography (PET)/ Computed Tomography (CT) radiopharmaceutical.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Patient will receive an IV injection of up to 200MBq 68Ga-RM2. Each patient will have torso PET/CT imaging at 2 timepoints. Alternate patients will have imaging at 1 and 2h post-injection then the next patientat 1 and 3h post-injection, with axillary gamma probe measurements (using a collimator) of 68Ga-RM2 at the same time points. Receives: Drug: 68Ga-RM2 |
| Group 2 | Experimental | WLE will be performed as per standard of care but will also include Intraoperative LightPath® Imaging with 68Ga-RM2. Group 2 scans will acquire LightPath® images of both intact and incised cancer specimens with varying parameters to optimise imaging. Receives: Combination Product: LightPath® Imaging System and 68Ga-RM2 |
| Group 3 | Experimental | WLE will be performed as per standard of care but will also include Intraoperative LightPath® Imaging with 68Ga-RM2. Group 3 scans will acquire LightPath® images of intact and incised cancer specimens using a final and consistent imaging procedure. Receives: Combination Product: LightPath® Imaging System and 68Ga-RM2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of LightPath® Imaging System
Agreement between margin status determined by LightPath® Imaging and post-operative histopathology (Group 3)
Measured: up to 5 year
Secondary outcomes (9)
Optimal scan time-window for 68Ga-RM2 PET/CT imaging
Group 1 only
Measured: 1 year
Gamma probe measurements (collimated) in the axilla to determine optimal 68Ga-RM2 activity
Group 1 only
Measured: 1 year
Value of 68Ga-RM2 PET/CT imaging for breast cancer staging
Group 1 only
Measured: 1 year
Radiation dosimetry measurements for the staff
Group 1 only
Measured: 1 year
Optimal device settings, tracer dose, and working procedures
Group 2 only
Measured: up to 2 years
Inter-rater agreement in post-operative standardised, controlled assessments of LightPath® Images
Group 3 only
Measured: up to 5 year
MDT decision to re-operate at index location
Group 3 only
Measured: up to 5 year
Weight of primary lump and lump plus shavings
Groups 2 and 3 only
Measured: up to 5 year
Radiation dosimetry for operating room and recovery area staff
Groups 2 and 3 only
Measured: up to 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start30 Nov 2018 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3-Group Study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lightpoint Medical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qamar B Akbar, MSc, Study director, Lightpoint Medical Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731026
- Sponsor's protocol ID
- LPM-008
- Status last verified
- Nov 2018
- First submitted
- 25 Jul 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the LightPath® Imaging System and the PET Tracer 68Ga-RM2 in Wide Local Excision (WLE) for Breast Cancer
- ClinicalTrials.gov ID
- NCT03731026
- Acronym / sponsor ID
- LPM-008
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lightpoint Medical LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2018 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 6 Nov 2018 (actual)
- 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, open-label study to examine the performance of the LightPath® Imaging System using the PET tracer 68Ga-RM2 in patients scheduled for and/or undergoing wide local excision (WLE) with or without sentinel lymph node biopsy (SLNB) or complete axillary lymph node dissection(cALND) for breast cancer with an ER-positive invasive primary cancer.
The study consists of 3 sequential groups:
Group 1 (N=20 patients): Torso, i.e. base of skull to thighs, PET/CT imaging and axillary gamma probe measurements (using a collimator) of 68Ga-RM2 to: determine the optimal scan time-window post-injection; to extrapolate the optimal dose for resolution against axillary background signal on gamma probe measurements (first 6 patients); and the value of 68Ga-RM2 PET/CT imaging for breast cancer staging (all 20 patients).
Group 2 (N=10 patients): Intraoperative LightPath® imaging with 68Ga-RM2 to familiarise site with procedure and interpretation of intraoperative scans,validate the dose and timings determined from Group 1, and optimise LightPath® Imaging parameters such as acquisition resolution and duration. Group 2 scans will acquire LightPath® images of both intact and incised cancer specimens for post-operative standardised, controlled assessment. Group 2 will use the optimal scan time-window and 68Ga-RM2 activity extrapolated from at least the first 6 patients in Group 1. The dose of 68Ga-RM2 will be determined to optimise the intra-operative imaging and axillary gamma probe measurements.
Group 3 (N=50 patients): Intraoperative LightPath® imaging with 68Ga-RM2 to measure agreement between LightPath® images and post-operative histopathology. Group 3 scans will acquire LightPath® images of intact and incised cancer specimens for post-operative standardised, controlled assessment. Group 3 will use the optimal scan time-window and 68Ga-RM2 activity extrapolated from the first 6 patients in Group 1 with the optimised imaging parameters, and dose developed from Group 2.
The intraoperative 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
The study site will use the local criteria considered standard of care to guide decisions to act on positive margins. Lightpoint Medical will provide guidance to act on LightPath® Images in the Instructions forUse (IFU). It will be at the Investigator's discretion to choose whether to act based upon the intraoperative LightPath® Images.
In Group 3,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. A positive margin on histology will be defined as
- Invasive carcinoma: positive: ink on tumour; close: <1mm; negative ≥1mm
- Ductal carcinoma in situ (DCIS)or pleomorphic lobular carcinoma in situ (LCIS) (if present): positive: ink on tumour; close: <2mm; negative ≥2mm.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3-Group Study
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Drug: 68Ga-RM2Patient will receive an IV injection of up to 200MBq 68Ga-RM2. Each patient will have torso PET/CT imaging at 2 timepoints. Alternate patients will have imaging at 1 and 2h post-injection then the next patientat 1 and 3h post-injection, with axillary gamma probe measurements (using a collimator) of 68Ga-RM2 at the same time points. |
| Group 2 | Experimental | Combination Product: LightPath® Imaging System and 68Ga-RM2WLE will be performed as per standard of care but will also include Intraoperative LightPath® Imaging with 68Ga-RM2. Group 2 scans will acquire LightPath® images of both intact and incised cancer specimens with varying parameters to optimise imaging. |
| Group 3 | Experimental | Combination Product: LightPath® Imaging System and 68Ga-RM2WLE will be performed as per standard of care but will also include Intraoperative LightPath® Imaging with 68Ga-RM2. Group 3 scans will acquire LightPath® images of intact and incised cancer specimens using a final and consistent imaging procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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 subjects ≥18 years of age with a diagnosis of ER-positive invasive breast cancer. ER-positivity is defined as an Allred score of 3 or more on immunohistochemical analysis.
- Female subjects 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 (7 listed)
- Subjects who have had surgery in the operated breast in the past 12months
- Subjects who have had radiotherapy in the operated breast
- Subjects who have had neoadjuvant systemic therapy
- Subjects who have had systemic chemotherapy or investigational therapy in the past two years
- Subjects who are pregnant or lactating
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 and 68Ga-RM2Imaging System:The LightPath® Imaging System is an in vitro diagnostic device which has CE mark in Europe, in line with In Vitro Diagnostic Medical Devices 98/79/EC (post-marketing study). Radiopharmaceutical: 68Ga-RM2 is an investigational Positron Emission Tomography (PET)/ Computed Tomography (CT) radiopharmaceutical. | Combination product | Group 2, Group 3 |
| 68Ga-RM2Radiopharmaceutical: 68Ga-RM2 is an investigational Positron Emission Tomography (PET)/ Computed Tomography (CT) radiopharmaceutical. | Drug | Group 1 |
Primary outcome
Diagnostic performance of LightPath® Imaging System
Time frame: up to 5 year
Agreement between margin status determined by LightPath® Imaging and post-operative histopathology (Group 3)
9 secondary outcomes
Optimal scan time-window for 68Ga-RM2 PET/CT imaging
Time frame: 1 year
Gamma probe measurements (collimated) in the axilla to determine optimal 68Ga-RM2 activity
Time frame: 1 year
Value of 68Ga-RM2 PET/CT imaging for breast cancer staging
Time frame: 1 year
Radiation dosimetry measurements for the staff
Time frame: 1 year
Optimal device settings, tracer dose, and working procedures
Time frame: up to 2 years
Inter-rater agreement in post-operative standardised, controlled assessments of LightPath® Images
Time frame: up to 5 year
MDT decision to re-operate at index location
Time frame: up to 5 year
Weight of primary lump and lump plus shavings
Time frame: up to 5 year
Radiation dosimetry for operating room and recovery area staff
Time frame: up to 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Individual participant dataSharing planned: No
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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
Lightpoint Medical Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LightPath® Imaging System and 68Ga-RM2 and 68Ga-RM2 in people with Breast Cancer, run by Lightpoint Medical Limited at 1 site in United Kingdom.
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 6 inclusion and 7 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 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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, MSc (+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 LightPath® Imaging System (time frame: up to 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2018.