Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
40 participants
OBSERVATIONAL
2024-06-01
2025-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Normal benign
participants with normal benign nodules (no cancer)
thyroid lobectomy
routine surgical removal of thyroid for biopsy
Raman spectroscopy probe measurement
The measurement of Raman spectra from the excised tissue
Follicular thyroid cancer
participants with follicular thyroid cancer
thyroid lobectomy
routine surgical removal of thyroid for biopsy
Raman spectroscopy probe measurement
The measurement of Raman spectra from the excised tissue
Papillary thyroid cancer
participants with papillary thyroid cancer
thyroid lobectomy
routine surgical removal of thyroid for biopsy
Raman spectroscopy probe measurement
The measurement of Raman spectra from the excised tissue
Anaplastic thyroid cancer
participants with anaplastic thyroid cancer
thyroid lobectomy
routine surgical removal of thyroid for biopsy
Raman spectroscopy probe measurement
The measurement of Raman spectra from the excised tissue
Medullary thyroid cancer
participants with medullary thyroid cancer
thyroid lobectomy
routine surgical removal of thyroid for biopsy
Raman spectroscopy probe measurement
The measurement of Raman spectra from the excised tissue
Interventions
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thyroid lobectomy
routine surgical removal of thyroid for biopsy
Raman spectroscopy probe measurement
The measurement of Raman spectra from the excised tissue
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients not attending for standard diagnostic biopsy for thyroid cancer
18 Years
ALL
No
Sponsors
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Gloucestershire Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Alex Dudgeon
Post-Doctoral Research Fellow
Locations
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Biophotonics Research Unit
Gloucester, Gloucestershire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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245612
Identifier Type: OTHER
Identifier Source: secondary_id
18/LO/1545
Identifier Type: OTHER
Identifier Source: secondary_id
18/044/GHT
Identifier Type: -
Identifier Source: org_study_id
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