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Differentiation of Benign From Malignant Thyroid Nodules Using Diffuse Reflectance Spectroscopy

Differentiation of Benign From Malignant Thyroid Nodules Using Diffuse Reflectance Spectroscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07124065
Enrollment
50
Registered
2025-08-15
Start date
2024-03-20
Completion date
2026-03-31
Last updated
2025-08-15

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

Conditions

Nodule Solitary Thyroid, Thyroid Cancer

Brief 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. 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.

Interventions

Spectral data collection with diffuse reflectance spectroscopy

Sponsors

Imperial College London
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* patients undergoing surgery for thyroid nodules * age 18 years and over * radiological/cytological assessment of nodule pre-operatively

Exclusion criteria

* declined consent * lack capacity * emergency surgery * re-operative surgery

Design outcomes

Primary

MeasureTime frameDescription
Cancer diagnosisSingle time point only (intra-operative data collection)To determine if DRS can differentiate cancerous nodules from benign from spectral data

Countries

United Kingdom

Outcome results

None listed

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