RAman For Thyroid cancER
RAman For Thyroid cancER
Ex vivo vibrational spectroscopy (VS), including Raman spectroscopy (RS) of thyroid tissue
 samples, collected from patients undergoing routine diagnostic thyroid biopsies for diagnosis
 of potential thyroid cancer. Raman spectra are to be correlated with consensus histopathology
 and clinical outcomes. Multivariate analysis to be used to evaluate the classification
 accuracy of VS ex vivo.
The Investigators (The Biophotonics Research Unit, University of Exeter and University of
 Bristol) have developed these "smart needle" probes, consisting of fibre-optics within a fine
 needle for investigating cancer below the skin's surface. It is difficult to create a
 sensitive probe to fit inside a needle; however, The Investigators have demonstrated this
 approach in lymph node tissue samples from 68 patients in the laboratory, where The
 Investigators showed that our probe could detect cancer with a high level of accuracy.

 Following on from our success with lymph nodes The Investigators wish to trial our smart
 needle on excised thyroid to demonstrate the device in another ENT cancer. Earlier studies
 have shown that thyroid cancer can be diagnosed using RS under a microscope with an accuracy
 greater than 78%.9 By eliminating the need for unnecessary surgery by diagnosis with our
 device, The Investigators will minimise the risk to patients, eliminate delays in obtaining
 results and reduce the cost of surgery and overnight stay in the hospital. The Investigators
 wish to advance this device closer to the clinic for a new cancer to improve the patient care
 pathway and remove the need for unnecessary surgery, by facilitating the work of the one-stop
 ENT diagnostic outpatient clinics.

 The study consists of measuring spectra of new tissue taken during routine diagnostic
 surgical thyroid lobectomy.

 New tissue for this project will be collected during routine biopsy will be rapidly analysed
 by a spectrometer before proceeding with conventional histopathological analysis. The new
 tissue will consist of thyroid and adjacent tissue biopsies. No additional tissue will be
 taken for this research, The Investigators only plan to measure samples taken during routine
 diagnosis in under 5 minutes, before passing the sections back to the surgical team for
 routine histopathological analysis.

 Anonymous background information relevant to known risk factors, family history and details
 of any treatment, menopausal status, details relevant medical procedures, and any treatment
 for thyroid cancer will be provided with the samples. An example of the report can be found
 in Appendix 3. Tissue specimens taken during routine clinical care are to be subjected to ex
 vivo vibrational spectroscopic analysis immediately prior to being sent for routine
 histopathological analysis. Vibrational spectra are to be correlated with consensus
 histopathology of adjacent sections. Multivariate analysis is to be used to evaluate the
 classification accuracy of VS ex vivo. The vibrational spectra will be assessed for both
 prognostic as well as diagnostic information.
Inclusion Criteria:

 -  Patients undergoing routine diagnostic thyroid biopsy at surgery

 Exclusion Criteria:

 -  Patients are unable to provide informed consent.

 -  Patients not attending for standard diagnostic biopsy for thyroid cancer