CLI Specimen Analyser for Ex-vivo Assessment of Margin and Lymph Node Status in Breast Cancer Surgical Specimens
This study is a prospective, cross-sectional observational single centre study to assess the feasibility of intra-operative Cerenkov Luminescence Imaging (CLI) of breast cancer wide local excision (WLE) specimens and dissected lymph nodes. The samples will be imaged using a CLI specimen analyser. The CLI specimen analyser consists of a light-tight box on which are mounted an ultra-sensitive lens and radiation-shielded camera. This study will measure the agreement between margin status of the WLE specimen and the metastatic status of dissected lymph nodes as determined by CLI and by histopathology. This is a pilot study to assess feasibility before proceeding to pivotal studies to determine diagnostic performance.
|Study Design:||Time Perspective: Prospective|
|Official Title:||A Pilot Study to Evaluate Cerenkov Luminescence Imaging for Measuring Margin and Lymph Node Status in Breast Cancer Surgical Specimens|
- Tumour margin status of the Wide Local Excision specimen as determined by CLI [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
- Metastatic status of dissected lymph nodes as determined by CLI [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
- Radiation dosimetry to operating theatre, recovery area and pathology staff [ Time Frame: Up to 24 hours after injection of radiopharmaceutical ] [ Designated as safety issue: Yes ]
- Ease of use of CLI Specimen Analyser [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
|Study Start Date:||June 2014|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Female patients ≥30 years of age with known breast cancer scheduled for breast-conserving surgery (BCS) +/- sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND)
Subject's blood glucose level will be measured on the day of surgery. Subjects with a blood glucose level < 12 mmol/l receive an intravenous injection of 5 MBq/kg, up to a maximum 300 MBq of 18F-fluorodeoxyglucose (18F-FDG) prior to surgery. Breast cancer surgery will be performed per standard of care. SLNB will be performed using a dose of 150 MBq technetium 99 (99mTc) nanocolloid and patent blue dye. The resected WLE specimen and lymph nodes will be imaged in the CLI specimen analyser. A member of the research team who is not the operating surgeon will capture CLI images intra-operatively.
Prior to CLI, the WLE specimen will be placed in a specimen holder. CLI is performed according to the CLI specimen analyser instructions for use. All CLI will be performed between 1 and 3 hours post injection of 18F-FDG.
The WLE specimen will then undergo standard of care histopathological analysis with a positive margin defined as either invasive carcinoma or ductal carcinoma in situ (DCIS) within 2mm of the specimen surface. Lymph nodes will also be examined according to standard of care histopathological analysis.
The CLI results will not be used to influence any surgical or clinical decision-making.
All staff in the operating theatre and the recovery area caring for the patient, and pathology staff processing surgical specimens will wear badge dosimeters. Staff handling surgical specimens will also wear ring dosimeters.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02037269
|Contact: Anand D Purushotham, MBBS FRCS MDfirstname.lastname@example.org|
|Contact: Maarten Grootendorst||0044 (0)20 7188 email@example.com|
|London, United Kingdom, SE1 9RT|
|Contact: Sweta Sethi 0044 (0)20 7188 0743 Sweta.Sethi@gstt.nhs.uk|
|Contact: Maarten Grootendorst 0044 (0)20 7188 0743 firstname.lastname@example.org|
|Principal Investigator: Anand D Purushotham, MBBS FRCS MD|
|Principal Investigator:||Anand D Purushotham, MBBS FRCS MD||King's College London|