CLI Specimen Analyser for Ex-vivo Assessment of Margin and Lymph Node Status in Breast Cancer Surgical Specimens

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Lightpoint Medical Limited
Sponsor:
Collaborators:
Guy's and St Thomas' NHS Foundation Trust
King's College London
Information provided by (Responsible Party):
Lightpoint Medical Limited
ClinicalTrials.gov Identifier:
NCT02037269
First received: January 14, 2014
Last updated: August 13, 2015
Last verified: August 2015

January 14, 2014
August 13, 2015
June 2014
March 2016   (final data collection date for primary outcome measure)
Tumour margin status of the Wide Local Excision specimen as determined by CLI [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02037269 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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: Peri-procedural ] [ Designated as safety issue: Yes ]
  • Ease of use of CLI Specimen Analyser [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
CLI Specimen Analyser for Ex-vivo Assessment of Margin and Lymph Node Status in Breast Cancer Surgical Specimens
A Pilot Study to Evaluate Cerenkov Luminescence Imaging for Measuring 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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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)

Breast Cancer
Not Provided
All participants
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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
June 2016
March 2016   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Females ≥30 years of age with a diagnosis of invasive breast cancer or DCIS
  • Scheduled for BCS +/- SLNB or ALND
  • Females of childbearing age must have a negative pregnancy test (by Beta HCG qualitative analysis), must have had a history of a surgical sterilisation, or must give history of no menses in past twelve months

Exclusion Criteria

  • Surgery or radiotherapy in the operated breast in the past 2 years
  • Neoadjuvant systemic therapy
  • Patients not suitable for BCS
  • Blood glucose level ≥ 12 mmol/l on the day of surgery
  • Known hypersensitivity to 18F-FDG
  • Any patient who is pregnant or lactating
Female
30 Years and older
No
Contact: Anand D Purushotham, MBBS FRCS MD ea-purushotham@kcl.ac.uk
Contact: Maarten Grootendorst 0044 (0)20 7188 0743 maarten.grootendorst@kcl.ac.uk
United Kingdom
 
NCT02037269
LPM-001
No
Lightpoint Medical Limited
Lightpoint Medical Limited
  • Guy's and St Thomas' NHS Foundation Trust
  • King's College London
Principal Investigator: Anand D Purushotham, MBBS FRCS MD King's College London
Lightpoint Medical Limited
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP