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Intraoperative Detection of Residual BCC by Fast Raman

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ClinicalTrials.gov Identifier: NCT03482622
Recruitment Status : Not yet recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Collaborators:
Nottingham University Hospitals NHS Trust
Circle Nottingham NHS Treatment Centre
Information provided by (Responsible Party):
University of Nottingham

Brief Summary:
The main objective of this research is to develop a new scanning technology called the Fast Raman device, to accurately check the skin removed by the surgeon and detect any residual cancer cells; if found, additional skin can then be removed by surgeons on the same day. The device will be tested first for patients undergoing Mohs micrographic surgery, then be extended to wide-local excisions of basal cell carcinoma (BCC). This study will determine the validity (sensitivity/specificity) and reliability (inter- and intra-user variability) of the Fast Raman device for checking the completeness of tumour removal during Mohs micrographic surgery of BCC.

Condition or disease Intervention/treatment
Carcinoma, Basal Cell Intraoperative BCC Detection by Fast Raman Device Diagnostic Test: Fast Raman

Detailed Description:

Raman spectroscopy (RS) is an established analytical technique and has been extensively used in medicine to study individual cells and complex tissues, including skin and skin cancers. This technique is based on inelastic scattering of laser light following its interaction with vibrating molecules of biological samples; therefore, a Raman spectrum represents a "chemical fingerprint" of the sample. Recently, the investigators demonstrated that Raman micro-spectroscopy is able to discriminate between healthy skin and BCC.

With National Institute for Health Research (NIHR) i4i funding (2007-2013), the investigators developed a new technology ("Fast Raman") that can detect BCC regions in skin layers excised during Mohs surgery [13]. A first laboratory prototype based on this technology was able to analyze specimens in 30-60 minutes. In a follow-up i4i project (2014-2016), the investigators have built a fully automated "Fast Raman" device that can be used by non-specialist users and meets the safety requirements to be used in the clinic. The investigators now intend to test this device in real clinical practice and to compare the diagnosis generated by the device with the standard pathology diagnosis.

If the performance of the device achieves the proposed target (~95% sensitivity and specificity, inter-and intra-user reliability higher than typical histopathology, assessment time shorter than frozen section histopathology), it will provide important benefit to BCC patients and health care providers. Faster tissue assessment could speed up Mohs surgery (around 90 mins rather than 3 hours), which is more comfortable for patients. By reducing the costly histopathology procedures needed to process and diagnose skin samples, the Fast Raman device will reduce health care costs, allowing Mohs surgery to become more widely available, and reducing the postcode lottery that currently exists. As the Fast Raman device is designed to be used by non-specialist user, it can be used during any type of BCC surgery, including standard wide local excisions of BCC (>80,000 procedures/year in UK), to provide on the spot an answer on whether the entire tumour has been excised or not.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Accurate Assessment of Tumour Clearance During Surgical Treatment of Basal Cell Carcinoma by Fast Raman Spectroscopy
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Group/Cohort Intervention/treatment
Patients undergoing Mohs surgery
Skin samples excised during Mohs surgery will be measured by the Fast Raman device. The Fast Raman measurements will be compared to gold standard histopathology to determine measurement accuracy.
Diagnostic Test: Fast Raman
Fast Raman uses Raman spectroscopy to measure chemical profiles of tissue and provide a diagnostic map identifying BCC within 30 minutes.




Primary Outcome Measures :
  1. Validity [ Time Frame: Immediate ]
    Accuracy (sensitivity/specificity) of diagnosis made by the Fast Raman device compared to frozen-section histopathology (standard practice) as a the standard of reference.


Secondary Outcome Measures :
  1. Reliability [ Time Frame: Immediate ]
    Intra- and inter-user variability in accuracy of Fast Raman results. Identify any conditions (patient groups, tissue types, procedural errors) that cause inaccurate diagnosis.

  2. Measurement Time [ Time Frame: Immediate ]
    Evaluate whether tissue layers can be analysed faster by the Fast Raman device than normal clinical practice.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consenting patients undergoing Mohs micrographic surgery of BCC.
Criteria

Inclusion Criteria:

  • Patients undergoing Mohs micrographic surgery of BCC.
  • Able to give informed consent.
  • Any age.

Exclusion Criteria:

  • Patients where there is any doubt regarding the diagnosis from pathologist as ascertained by previous diagnostic biopsy.

Information from the National Library of Medicine

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): NCT03482622


Contacts
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Contact: Ioan Notingher, PhD 0115 951 5172 ioan.notingher@nottingham.ac.uk

Sponsors and Collaborators
University of Nottingham
Nottingham University Hospitals NHS Trust
Circle Nottingham NHS Treatment Centre
Investigators
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Principal Investigator: Ioan Notingher, PhD University of Nottingham

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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03482622    
Other Study ID Numbers: 18003
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No identifying patient data will be stored as part of this study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Nottingham:
Raman spectroscopy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell