NCT07124065

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

August 8, 2025

Last Update Submit

August 8, 2025

Conditions

Thyroid CancerNodule Solitary Thyroid

Outcome Measures

Primary Outcomes (1)

  • Cancer diagnosis

    To determine if DRS can differentiate cancerous nodules from benign from spectral data

    Single time point only (intra-operative data collection)

Study Arms (1)

All patients undergoing surgery for thyroid nodules

Diagnostic Test: Diffuse reflectance spectroscopy

Interventions

Diffuse reflectance spectroscopyDIAGNOSTIC_TEST

Spectral data collection with diffuse reflectance spectroscopy

All patients undergoing surgery for thyroid nodules

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing surgery for thyroid nodules at Hammersmith Hospital, UK

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2025

First Posted

August 15, 2025

Study Start

March 20, 2024

Primary Completion

December 31, 2024

Study Completion

March 31, 2026

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)