Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2022-11-21
2024-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Breast Cancer undergoing BCS
Intraoperative CLI + FAR LightPath imaging compared with Standard-of-care histopathology (gold standard)
Intraoperative CLI + FAR LightPath imaging
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
Interventions
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Intraoperative CLI + FAR LightPath imaging
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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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King's College London
OTHER
Responsible Party
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Locations
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Guy's and St Thomas NHS Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Arnie Purushotham
Role: primary
Other Identifiers
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IRAS 314460
Identifier Type: -
Identifier Source: org_study_id
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