Clinical trial NCT05496101: CLI and FAR for Intraoperative Margin Assessment
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer Female
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intraoperative CLI + FAR LightPath imaging with comparator-Standard-of-care histopathology (gold standard)
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* • 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Margin status of WLE specimens
timeFrame: complete surgical procedure
Secondary outcomes:
measure: • Agreement between margin status of cavity shavings as determined by intraoperative CLI + FAR LightPath imaging and post-operative histopathology.
timeFrame: complete surgical procedure
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas NHS Trust
Study officials:
References: