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 June 2014 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: June 23, 2014
Last verified: June 2014

January 14, 2014
June 23, 2014
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: Peri-procedural ] [ Designated as safety issue: Yes ]
  • Ease of use of CLI Specimen Analyser [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]
Same as current
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 will test the feasibility of using a Cerenkov Luminescence Imaging (CLI) Specimen Analyser for:

  1. the ex-vivo measurement of surgical margin status in breast cancer surgical specimens and;
  2. metastatic status of excised lymph nodes.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Female patients ≥18 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
Females with a diagnosis of breast cancer scheduled to have breast conserving surgery +/- sentinel lymph node biopsy or axillary lymph node dissection
Not Provided

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

Inclusion Criteria:

  • Females ≥ 50 years of age with a diagnosis of invasive breast cancer or ductal carcinoma in-situ (DCIS)
  • Scheduled for Brest Conserving Surgery (BCS) +/- Sentinel Lymph Node Biopsy (SLNB) or Axillary Lymph Node Dissection (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
50 Years and older
No
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
June 2014

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