Breast Cancer FemalePhase 2CLI-FARNCT05496101
CLI and FAR for Intraoperative Margin Assessment
A Phase 2 study testing Intraoperative CLI + FAR LightPath imaging in people with Breast Cancer Female, run by King's College London at 1 site in United Kingdom.
Trial summary
This study is a prospective, single arm interventional study to evaluate the diagnostic accuracy of intraoperative Cerenkov luminescence imaging (CLI) plus flexible autoradiography (FAR) using the LightPath® Imaging System for intraoperative tumour margin assessment compared to post-operative standard-of-care… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Intraoperative CLI + FAR LightPath imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Nov 2022to 31 Dec 2024
- Phase
- Phase 2
- 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
- • Female subjects ≥18 years of age with a diagnosis of invasive breast cancer scheduled to undergo BCS
- 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 of childbearing age must have a negative pregnancy test (by Beta human chorionic gonadotrophin (β-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 who have had surgery to the ipsilateral breast in the past 12 months
- Subjects who have had radiotherapy to the ipsilateral breast
- Subjects who have a 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas NHS Trust
London, SE19RT
Arnie Purushotham, 0207188188 ext. 3027
About this study
Official title: Intraoperative Assessment of Tumour Excision Margins Using the LightPath Imaging System for Cerenkov Luminescence Imaging (CLI) Combined With Flexible Autoradiography (FAR) in Women Undergoing Breast-conserving Surgery (BCS)
This study is a prospective, single arm interventional study to evaluate the diagnostic accuracy of intraoperative Cerenkov luminescence imaging (CLI) plus flexible autoradiography (FAR) using the LightPath® Imaging System for intraoperative tumour margin assessment compared to post-operative standard-of-care histopathology in women undergoing breast-conserving surgery for breast cancer.
Read the detailed description
The intraoperative LightPath images will be used to inform the operating surgeon about potentially detectable cancer at the margins of the excised specimen in an attempt to achieve better guided cancer surgery and complete tumour excision with clear resection margins. If a positive excision margin is detected on intraoperative LightPath® images, the operating surgeon will take a cavity shaving of the corresponding margin, provided more tissue can be taken. Subsequent LightPath® imaging of the cavity shaving will inform the operating surgeon on the margin status of the shaving. If a positive excision margin is detected on intraoperative LightPath® images, the operating surgeon will take a further cavity shave of the corresponding margin, provided more tissue can be taken.
The resection margin status of the WLE specimen and cavity shavings (if any), as assessed by LightPath CLI + FAR imaging will be compared with final histopathology results.
A positive margin on histology will be defined as
- Invasive carcinoma: positive: <1mm; negative ≥1mm
- Ductal carcinoma in situ (DCIS) (if present): positive: <2mm; negative ≥2mm.
- Conditions
- Breast Cancer Female
- Being tested
- Intraoperative CLI + FAR LightPath imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative CLI + FAR LightPath imagingProcedure or surgery
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:
18F-FDG is a routinely used Positron Emission Tomography (PET) / Computed Tomography (CT) radiopharmaceutical
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer undergoing BCS | Other | Intraoperative CLI + FAR LightPath imaging compared with Standard-of-care histopathology (gold standard) Receives: Procedure: Intraoperative CLI + FAR LightPath imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Margin status of WLE specimens
The resection margin status of the WLE specimen and cavity shavings (if any), as assessed by LightPath CLI + FAR imaging will be compared with final histopathology results. A positive margin on histology will be defined as
- Invasive carcinoma: positive: <1mm; negative ≥1mm
- Ductal carcinoma in situ (DCIS) (if present): positive: <2mm; negative ≥2mm. The resection margin status of the WLE specimen and cavity shavings (if any), as assessed by LightPath CLI + FAR imaging will be compared with final histopathology results. A positive margin on histology will be defined as
- Invasive carcinoma: positive: <1mm; negative ≥1mm
- Ductal carcinoma in situ (DCIS) (if present): positive: <2mm; negative ≥2mm.
Measured: complete surgical procedure
Secondary outcomes (1)
• Agreement between margin status of cavity shavings as determined by intraoperative CLI + FAR LightPath imaging and post-operative histopathology.
- Re-operation rate within the study cohort compared to general breast cancer population undergoing a WLE.
Measured: complete surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start21 Nov 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intraoperative CLI + FAR LightPath imaging with comparator-Standard-of-care histopathology (gold standard)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496101
- Sponsor's protocol ID
- IRAS 314460
- Acronym
- CLI-FAR
- Status last verified
- Feb 2024
- First submitted
- 29 Apr 2022
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Assessment of Tumour Excision Margins Using the LightPath Imaging System for Cerenkov Luminescence Imaging (CLI) Combined With Flexible Autoradiography (FAR) in Women Undergoing Breast-conserving Surgery (BCS)
- ClinicalTrials.gov ID
- NCT05496101
- Acronym / sponsor ID
- CLI-FAR / IRAS 314460
- Conditions
- Breast Cancer Female
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Aug 2022 (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, single arm interventional study to evaluate the diagnostic accuracy of intraoperative Cerenkov luminescence imaging (CLI) plus flexible autoradiography (FAR) using the LightPath® Imaging System for intraoperative tumour margin assessment compared to post-operative standard-of-care histopathology in women undergoing breast-conserving surgery for breast cancer.
Detailed description
The intraoperative LightPath images will be used to inform the operating surgeon about potentially detectable cancer at the margins of the excised specimen in an attempt to achieve better guided cancer surgery and complete tumour excision with clear resection margins. If a positive excision margin is detected on intraoperative LightPath® images, the operating surgeon will take a cavity shaving of the corresponding margin, provided more tissue can be taken. Subsequent LightPath® imaging of the cavity shaving will inform the operating surgeon on the margin status of the shaving. If a positive excision margin is detected on intraoperative LightPath® images, the operating surgeon will take a further cavity shave of the corresponding margin, provided more tissue can be taken.
The resection margin status of the WLE specimen and cavity shavings (if any), as assessed by LightPath CLI + FAR imaging will be compared with final histopathology results.
A positive margin on histology will be defined as
- Invasive carcinoma: positive: <1mm; negative ≥1mm
- Ductal carcinoma in situ (DCIS) (if present): positive: <2mm; negative ≥2mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intraoperative CLI + FAR LightPath imaging with comparator-Standard-of-care histopathology (gold standard)
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer undergoing BCS | Other | Procedure: Intraoperative CLI + FAR LightPath imagingIntraoperative CLI + FAR LightPath imaging compared with Standard-of-care histopathology (gold standard) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Female subjects ≥18 years of age with a diagnosis of invasive breast cancer scheduled to undergo BCS
Key exclusion criteria (5 listed)
- Subjects who have had surgery to the ipsilateral breast in the past 12 months
- Subjects who have had radiotherapy to the ipsilateral breast
- Subjects who have a 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
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 |
|---|---|---|
| Intraoperative CLI + FAR LightPath imagingImaging 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: 18F-FDG is a routinely used Positron Emission Tomography (PET) / Computed Tomography (CT) radiopharmaceutical | Procedure or surgery | Breast Cancer undergoing BCS |
Primary outcome
Margin status of WLE specimens
Time frame: complete surgical procedure
The resection margin status of the WLE specimen and cavity shavings (if any), as assessed by LightPath CLI + FAR imaging will be compared with final histopathology results. A positive margin on histology will be defined as * Invasive carcinoma: positive: <1mm; negative ≥1mm * Ductal carcinoma in situ (DCIS) (if present): positive: <2mm; negative ≥2mm. The resection margin status of the WLE specimen and cavity shavings (if any), as assessed by LightPath CLI + FAR imaging will be compared with final histopathology results. A positive margin on histology will be defined as * Invasive carcinoma: positive: <1mm; negative ≥1mm * Ductal carcinoma in situ (DCIS) (if present): positive: <2mm; negative ≥2mm.
1 secondary outcome
• Agreement between margin status of cavity shavings as determined by intraoperative CLI + FAR LightPath imaging and post-operative histopathology.
Time frame: complete surgical procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intraoperative CLI + FAR LightPath imaging in people with Breast Cancer Female, run by King's College London 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 4 inclusion and 5 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 5 Feb 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Arnie Purushotham (0207188188 ext. 3027, Arnie.purushotham@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Margin status of WLE specimens (time frame: complete surgical procedure). 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 5 Feb 2024.