LightPathTM Imaging System 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 March 2016 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: March 11, 2016
Last verified: March 2016
  Purpose
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 the LightPathTM Imaging System. The LightPathTM Imaging System which consists of a light-tight box on which are mounted an ultra-sensitive lens and radiation-shielded camera. This study will measure the correlation between margin status of the WLE specimen and the metastatic status of dissected lymph nodes as determined by the LightPathTM Imaging System and by histopathology. This is a pilot study to assess feasibility before proceeding to a pivotal study to evaluate the benefits of the LightPathTM Imaging System in clinical practice.

Condition
Breast Cancer

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Lightpoint Medical Limited:

Primary Outcome Measures:
  • Tumour margin status of the Wide Local Excision specimen as determined by the LightPathTM Imaging System [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Metastatic status of dissected lymph nodes as determined by the LightPathTM Imaging System [ 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 the LightPathTM Imaging System [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
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)
Groups/Cohorts
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)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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)
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02037269

Contacts
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

Locations
United Kingdom
Guy's Hospital Recruiting
London, United Kingdom, SE1 9RT
Contact: Sanjay Mistry    0044 (0)20 7188 0743    sanjay.mistry@gstt.nhs.uk   
Contact: Maarten Grootendorst    0044 (0)20 7188 0743    maarten.grootendorst@kcl.ac.uk   
Principal Investigator: Anand D Purushotham, MBBS FRCS MD         
Sponsors and Collaborators
Lightpoint Medical Limited
Guy's and St Thomas' NHS Foundation Trust
King's College London
Investigators
Principal Investigator: Anand D Purushotham, MBBS FRCS MD King's College London
  More Information

Additional Information:
Responsible Party: Lightpoint Medical Limited
ClinicalTrials.gov Identifier: NCT02037269     History of Changes
Other Study ID Numbers: LPM-001 
Study First Received: January 14, 2014
Last Updated: March 11, 2016
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by Lightpoint Medical Limited:
Cerenkov Luminescence Imaging, CLI, margin status

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on May 26, 2016