Thyroid CancerNCT07124065
Differentiation of Benign From Malignant Thyroid Nodules Using Diffuse Reflectance Spectroscopy
An observational study of Thyroid Cancer and Nodule Solitary Thyroid, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Patients with thyroid nodules are currently investigated with ultrasound with or without biopsy. Despite these investigations, a subset of patients remain "indeterminate" whereby a cancer can neither be diagnosed nor ruled out - these patients will usually be recommended to undergo diagnostic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Nodule Solitary Thyroid
- What is being tested?
- Diffuse reflectance spectroscopy
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Mar 2024to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients undergoing surgery for thyroid nodules at Hammersmith Hospital, UK
Who may be able to join
- patients undergoing surgery for thyroid nodules
- age 18 years and over
- radiological/cytological assessment of nodule pre-operatively
Who cannot join
- declined consent
- lack capacity
- emergency surgery
- re-operative surgery
Trial locations and contacts
1 site in 1 country.
About this study
Patients with thyroid nodules are currently investigated with ultrasound with or without biopsy. Despite these investigations, a subset of patients remain "indeterminate" whereby a cancer can neither be diagnosed nor ruled out - these patients will usually be recommended to undergo diagnostic surgery. This study aims to assess a new technique called diffuse reflectance spectroscopy to determine if this can differentiate between benign and cancerous nodules, particularly in these indeterminate cases.
Read the detailed description
Diffuse reflectance spectroscopy is an imaging technique which is conducted via a probe that is placed into direct contact with the tissue. This probe emits light, and simultaneously measures the light reflected back - differences in this reflected light can provide valuable information which may be able to differentiate cancerous from non-cancerous tissue. Several previous studies have proven this technique useful in other tissues, such as the stomach and oesophagus - this study therefore aims to assess its utility for thyroid nodules
The spectroscopic probe is used on the tissue that has already been taken from the body as part of the operation, not on the inside of the body itself. The tissue samples being removed will routinely be sent for microscopic analysis to inform the surgeon about the type of tissues present in the area of the body being operated on. The research team will be in the operating theatre and use the optical probe on the tissue samples.The probe will only be used on the tissue after it has been removed by the surgeon; therefore, the probe will not impact on the operation.
The overall aim of the study is to determine if this probe is able to differentiate which nodules are benign and which are cancerous.
- Conditions
- Thyroid Cancer, Nodule Solitary Thyroid
- Being tested
- Diffuse reflectance spectroscopy
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffuse reflectance spectroscopyDiagnostic test
Spectral data collection with diffuse reflectance spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| All patients undergoing surgery for thyroid nodules | Not described Receives: Diagnostic Test: Diffuse reflectance spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer diagnosis
To determine if DRS can differentiate cancerous nodules from benign from spectral data
Measured: Single time point only (intra-operative data collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start20 Mar 2024
- Primary completion31 Dec 2024
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124065
- Sponsor's protocol ID
- 08/H0719/37
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiation of Benign From Malignant Thyroid Nodules Using Diffuse Reflectance Spectroscopy
- ClinicalTrials.gov ID
- NCT07124065
- Acronym / sponsor ID
- 08/H0719/37
- Conditions
- Thyroid Cancer, Nodule Solitary Thyroid
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with thyroid nodules are currently investigated with ultrasound with or without biopsy. Despite these investigations, a subset of patients remain "indeterminate" whereby a cancer can neither be diagnosed nor ruled out - these patients will usually be recommended to undergo diagnostic surgery. This study aims to assess a new technique called diffuse reflectance spectroscopy to determine if this can differentiate between benign and cancerous nodules, particularly in these indeterminate cases.
Detailed description
Diffuse reflectance spectroscopy is an imaging technique which is conducted via a probe that is placed into direct contact with the tissue. This probe emits light, and simultaneously measures the light reflected back - differences in this reflected light can provide valuable information which may be able to differentiate cancerous from non-cancerous tissue. Several previous studies have proven this technique useful in other tissues, such as the stomach and oesophagus - this study therefore aims to assess its utility for thyroid nodules
The spectroscopic probe is used on the tissue that has already been taken from the body as part of the operation, not on the inside of the body itself. The tissue samples being removed will routinely be sent for microscopic analysis to inform the surgeon about the type of tissues present in the area of the body being operated on. The research team will be in the operating theatre and use the optical probe on the tissue samples.The probe will only be used on the tissue after it has been removed by the surgeon; therefore, the probe will not impact on the operation.
The overall aim of the study is to determine if this probe is able to differentiate which nodules are benign and which are cancerous.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients undergoing surgery for thyroid nodules | – | Diagnostic Test: Diffuse reflectance spectroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing surgery for thyroid nodules at Hammersmith Hospital, UK
Key inclusion criteria (3 listed)
- patients undergoing surgery for thyroid nodules
- age 18 years and over
- radiological/cytological assessment of nodule pre-operatively
Key exclusion criteria (4 listed)
- declined consent
- lack capacity
- emergency surgery
- re-operative surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffuse reflectance spectroscopySpectral data collection with diffuse reflectance spectroscopy | Diagnostic test | All patients undergoing surgery for thyroid nodules |
Primary outcome
Cancer diagnosis
Time frame: Single time point only (intra-operative data collection)
To determine if DRS can differentiate cancerous nodules from benign from spectral data
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer and Nodule Solitary Thyroid, run by Imperial College London 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 15 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cancer diagnosis (time frame: Single time point only (intra-operative data collection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2025.