RAman For Thyroid cancER

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Role of Vibrational Spectroscopy in the Diagnosis of Premalignant and Malignant Disease of the Thyroid RAFTER (RAman For Thyroid cancER)

Conditions
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Thyroid Diseases, Thyroid Cancer

Intervention / Treatment
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* Procedure: thyroid lobectomy
* Device: Raman spectroscopy probe measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal benign<br>participants with normal benign nodules (no cancer) | Procedure: thyroid lobectomy<br>* routine surgical removal of thyroid for biopsy<br>* Other names: thyroid nodule removal;Device: Raman spectroscopy probe measurement<br>* The measurement of Raman spectra from the excised tissue<br>|
| Follicular thyroid cancer<br>participants with follicular thyroid cancer | Procedure: thyroid lobectomy<br>* routine surgical removal of thyroid for biopsy<br>* Other names: thyroid nodule removal;Device: Raman spectroscopy probe measurement<br>* The measurement of Raman spectra from the excised tissue<br>|
| Papillary thyroid cancer<br>participants with papillary thyroid cancer | Procedure: thyroid lobectomy<br>* routine surgical removal of thyroid for biopsy<br>* Other names: thyroid nodule removal;Device: Raman spectroscopy probe measurement<br>* The measurement of Raman spectra from the excised tissue<br>|
| Anaplastic thyroid cancer<br>participants with anaplastic thyroid cancer | Procedure: thyroid lobectomy<br>* routine surgical removal of thyroid for biopsy<br>* Other names: thyroid nodule removal;Device: Raman spectroscopy probe measurement<br>* The measurement of Raman spectra from the excised tissue<br>|
| Medullary thyroid cancer<br>participants with medullary thyroid cancer | Procedure: thyroid lobectomy<br>* routine surgical removal of thyroid for biopsy<br>* Other names: thyroid nodule removal;Device: Raman spectroscopy probe measurement<br>* The measurement of Raman spectra from the excised tissue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test the Raman needle probe on freshly exised tissue | Measure Raman spectra and match with histopathology. Perform leave-one-out analysis to measure performance of diagnosis of Raman spectroscopy | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculate diagnostic performance of Raman spectroscopy probe for thyroid cancer | Diagnostic performance (specificity and sensitivity) of Raman spectroscopy (RS) for differentiation of thyroid cancer vs normal benign (no cancer). Diagnostic performance of RS for differentiation of thyroid cancer types. Papillary thyroid cancer Follicular thyroid cancer Anaplastic thyroid cancer Medullary thyroid cancer | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, Raman, thyroid