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Thyroid DiseasesRAFTERNCT04040673

RAman For Thyroid cancER

An observational study of Thyroid Diseases and Thyroid Cancer, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Diseases, Thyroid Cancer
What is being tested?
thyroid lobectomy and Raman spectroscopy probe measurement
How many people
0 participants
Where
1 siteUnited Kingdom
Study dates
31 Jan 2024to 31 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients attending for routine diagnostic biopsy

Who may be able to join

  • Patients undergoing routine diagnostic thyroid biopsy at surgery

Who cannot join

  • Patients are unable to provide informed consent.
  • Patients not attending for standard diagnostic biopsy for thyroid cancer

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Biophotonics Research Unit

    Gloucester, Gloucestershire, GL1 2AF

Other trials in United Kingdom

About this study

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)

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.

Read the 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.

Being tested
thyroid lobectomy, Raman spectroscopy probe measurement
Keywords
cancer, Raman, thyroid
Medical subject headings
Thyroid Diseases, Thyroid Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • thyroid lobectomyProcedure or surgery

    Also called thyroid nodule removal

    routine surgical removal of thyroid for biopsy

  • Raman spectroscopy probe measurementDevice

    The measurement of Raman spectra from the excised tissue

Study groups in NCT04040673
Study groupRoleWhat they receive
Normal benignparticipants with normal benign nodules (no cancer)
Receives: Procedure: thyroid lobectomy; Device: Raman spectroscopy probe measurement
Follicular thyroid cancerparticipants with follicular thyroid cancer
Receives: Procedure: thyroid lobectomy; Device: Raman spectroscopy probe measurement
Papillary thyroid cancerparticipants with papillary thyroid cancer
Receives: Procedure: thyroid lobectomy; Device: Raman spectroscopy probe measurement
Anaplastic thyroid cancerparticipants with anaplastic thyroid cancer
Receives: Procedure: thyroid lobectomy; Device: Raman spectroscopy probe measurement
Medullary thyroid cancerparticipants with medullary thyroid cancer
Receives: Procedure: thyroid lobectomy; Device: Raman spectroscopy probe measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 year

Secondary outcomes (1)

  1. 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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2019
  2. Study start31 Jan 2024
  3. Primary completion31 Jan 2025
  4. Study completion31 Jan 2025

Why it stopped: Covid19 halted study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04040673
Sponsor's protocol ID
18/044/GHT
Other IDs
245612, 18/LO/1545
Acronym
RAFTER
Status last verified
Sep 2026
First submitted
29 Jul 2019
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Pathology reports will be linked using a pseudo-anonymous unique study identifier

Publications

  • 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.

    PubMed 23275525

  • 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.

    PubMed 27190582

  • 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.

    PubMed 28663910

  • 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.

    PubMed 15928665

  • 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.

    PubMed 29097686

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroid Diseases and Thyroid Cancer, run by Gloucestershire Hospitals NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Test the Raman needle probe on freshly exised tissue (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04040673, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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