RAman For Thyroid cancER (RAFTER)

February 23, 2024 updated by: Alex Dudgeon, Gloucestershire Hospitals NHS Foundation Trust

Evaluation of the Role of Vibrational Spectroscopy in the Diagnosis of Premalignant and Malignant Disease of the Thyroid RAFTER (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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Gloucestershire
      • Gloucester, Gloucestershire, United Kingdom, GL1 2AF
        • Biophotonics Research Unit
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexander P Dudgeon, PhD
        • Sub-Investigator:
          • Catherine A Kendall, PhD
        • Sub-Investigator:
          • Charlie Hall, MBBS
        • Sub-Investigator:
          • Maryam Nowghani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients attending for routine diagnostic biopsy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal benign
participants with normal benign nodules (no cancer)
Procedure: thyroid lobectomy
routine surgical removal of thyroid for biopsy
Other Names:
  • thyroid nodule removal
Device: Raman spectroscopy probe measurement
The measurement of Raman spectra from the excised tissue
Follicular thyroid cancer
participants with follicular thyroid cancer
Procedure: thyroid lobectomy
routine surgical removal of thyroid for biopsy
Other Names:
  • thyroid nodule removal
Device: Raman spectroscopy probe measurement
The measurement of Raman spectra from the excised tissue
Papillary thyroid cancer
participants with papillary thyroid cancer
Procedure: thyroid lobectomy
routine surgical removal of thyroid for biopsy
Other Names:
  • thyroid nodule removal
Device: Raman spectroscopy probe measurement
The measurement of Raman spectra from the excised tissue
Anaplastic thyroid cancer
participants with anaplastic thyroid cancer
Procedure: thyroid lobectomy
routine surgical removal of thyroid for biopsy
Other Names:
  • thyroid nodule removal
Device: Raman spectroscopy probe measurement
The measurement of Raman spectra from the excised tissue
Medullary thyroid cancer
participants with medullary thyroid cancer
Procedure: thyroid lobectomy
routine surgical removal of thyroid for biopsy
Other Names:
  • thyroid nodule removal
Device: Raman spectroscopy probe measurement
The measurement of Raman spectra from the excised tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test the Raman needle probe on freshly exised tissue
Time Frame: 1 year
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
Time Frame: 1 year

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gloucestershire Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18/044/GHT
  • 245612 (Other Identifier: IRAS)
  • 18/LO/1545 (Other Identifier: REC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pathology reports will be linked using a pseudo-anonymous unique study identifier

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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