NCT02037269

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

January 14, 2014

Last Update Submit

August 9, 2016

Conditions

Breast Cancer

Keywords

Cerenkov Luminescence Imaging, CLI, margin status

Outcome Measures

Primary Outcomes (1)

  • Tumour margin status of the Wide Local Excision specimen as determined by the LightPathTM Imaging System

    Intra-operative

Secondary Outcomes (3)

  • Metastatic status of dissected lymph nodes as determined by the LightPathTM Imaging System

    Intra-operative

  • Radiation dosimetry to operating theatre, recovery area and pathology staff

    Up to 24 hours after injection of radiopharmaceutical

  • Ease of use of the LightPathTM Imaging System

    Intra-operative

Study Arms (1)

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)

Eligibility Criteria

Age30 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

Related Publications (1)

  • Grootendorst MR, Cariati M, Pinder SE, Kothari A, Douek M, Kovacs T, Hamed H, Pawa A, Nimmo F, Owen J, Ramalingam V, Sethi S, Mistry S, Vyas K, Tuch DS, Britten A, Van Hemelrijck M, Cook GJ, Sibley-Allen C, Allen S, Purushotham A. Intraoperative Assessment of Tumor Resection Margins in Breast-Conserving Surgery Using 18F-FDG Cerenkov Luminescence Imaging: A First-in-Human Feasibility Study. J Nucl Med. 2017 Jun;58(6):891-898. doi: 10.2967/jnumed.116.181032. Epub 2016 Dec 8.

    PMID: 27932562DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Anand D Purushotham, MBBS FRCS MD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 15, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

August 10, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)