LightPathTM Imaging System for Ex-vivo Assessment of Margin and Lymph Node Status in Breast Cancer Surgical Specimens
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|ClinicalTrials.gov Identifier: NCT02037269|
Recruitment Status : Completed
First Posted : January 15, 2014
Last Update Posted : August 10, 2016
|Condition or disease|
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 LightPathTM Imaging System. A member of the research team who is not the operating surgeon will capture LightPathTM images intra-operatively.
Prior to CLI, the WLE specimen will be placed in a specimen holder. CLI is performed according to the LightPathTM Imaging System 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.
|Study Type :||Observational|
|Actual Enrollment :||25 participants|
|Official Title:||A Pilot Study to Evaluate Cerenkov Luminescence Imaging for Measuring Margin and Lymph Node Status in Breast Cancer Surgical Specimens|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||July 2016|
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)
- Tumour margin status of the Wide Local Excision specimen as determined by the LightPathTM Imaging System [ Time Frame: Intra-operative ]
- Metastatic status of dissected lymph nodes as determined by the LightPathTM Imaging System [ Time Frame: Intra-operative ]
- Radiation dosimetry to operating theatre, recovery area and pathology staff [ Time Frame: Up to 24 hours after injection of radiopharmaceutical ]
- Ease of use of the LightPathTM Imaging System [ Time Frame: Intra-operative ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02037269
|London, United Kingdom, SE1 9RT|
|Principal Investigator:||Anand D Purushotham, MBBS FRCS MD||King's College London|