RAman For Thyroid cancER

Thyroid Cancer Clinical Trial

— RAFTER  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04040673
• Other study ID #: 18/044/GHT
• Secondary ID: 24561218/LO/1545
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: February 2024
• Source: Gloucestershire Hospitals NHS Foundation Trust
• Contact: Julia Hall
• Phone: +443004225466
• Email: julia.hall9[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• thyroid lobectomy
routine surgical removal of thyroid for biopsy

Device:
• Raman spectroscopy probe measurement
The measurement of Raman spectra from the excised tissue

Locations

Country	Name	City	State
United Kingdom	Biophotonics Research Unit	Gloucester	Gloucestershire

Sponsors (1)

Lead Sponsor	Collaborator
Gloucestershire Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

Crow P, Barrass B, Kendall C, Hart-Prieto M, Wright M, Persad R, Stone N. The use of Raman spectroscopy to differentiate between different prostatic adenocarcinoma cell lines. Br J Cancer. 2005 Jun 20;92(12):2166-70. doi: 10.1038/sj.bjc.6602638. — View Citation

Feng X, Moy AJ, Nguyen HTM, Zhang J, Fox MC, Sebastian KR, Reichenberg JS, Markey MK, Tunnell JW. Raman active components of skin cancer. Biomed Opt Express. 2017 May 4;8(6):2835-2850. doi: 10.1364/BOE.8.002835. eCollection 2017 Jun 1. — View Citation

Jenkins CA, Lewis PD, Dunstan PR, Harris DA. Role of Raman spectroscopy and surface enhanced Raman spectroscopy in colorectal cancer. World J Gastrointest Oncol. 2016 May 15;8(5):427-38. doi: 10.4251/wjgo.v8.i5.427. — View Citation

Kamran SC, Marqusee E, Kim MI, Frates MC, Ritner J, Peters H, Benson CB, Doubilet PM, Cibas ES, Barletta J, Cho N, Gawande A, Ruan D, Moore FD Jr, Pou K, Larsen PR, Alexander EK. Thyroid nodule size and prediction of cancer. J Clin Endocrinol Metab. 2013 Feb;98(2):564-70. doi: 10.1210/jc.2012-2968. Epub 2012 Dec 28. — View Citation

Rau JV, Fosca M, Graziani V, Taffon C, Rocchia M, Caricato M, Pozzilli P, Onetti Muda A, Crescenzi A. Proof-of-concept Raman spectroscopy study aimed to differentiate thyroid follicular patterned lesions. Sci Rep. 2017 Nov 2;7(1):14970. doi: 10.1038/s41598-017-14872-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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