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RAman For Thyroid cancER

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04040673
Acronym
RAFTER
Enrollment
40
Registered
2019-08-01
Start date
2024-06-01
Completion date
2025-06-01
Last updated
2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Cancer, Thyroid Diseases

Keywords

cancer, Raman, thyroid

Brief 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.

Detailed 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.

Interventions

routine surgical removal of thyroid for biopsy

DEVICERaman spectroscopy probe measurement

The measurement of Raman spectra from the excised tissue

Sponsors

Gloucestershire Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Test the Raman needle probe on freshly exised tissue1 yearMeasure Raman spectra and match with histopathology. Perform leave-one-out analysis to measure performance of diagnosis of Raman spectroscopy

Secondary

MeasureTime frameDescription
Calculate diagnostic performance of Raman spectroscopy probe for thyroid cancer1 yearDiagnostic 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

Countries

United Kingdom

Contacts

Primary ContactJulia Hall
julia.hall9@nhs.net+443004225466

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026