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Real-time Molecular Diagnosis of Oral Precancer

NCT07110623 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-08-19

No results posted yet for this study

Summary

The "Real-time molecular diagnosis of oral precancer" or the LIP study is testing a new device for the detection of cancer in the mouth.

Oral cancers are serious and devastating illnesses, especially if detected at a late stage. Currently, the detection of oral cancer relies on testing a biopsy, which involves cutting a small section of tissue from the mouth and sending it to the pathology laboratory for further testing. A doctor or dentist taking the biopsy must rely on their own eyesight and experience to spot areas of concern. It can therefore be difficult to detect the earliest stages of cancer. At times, cancer tissue is only detected because it has already developed, and this affects the success of the treatment.

The device tested in this study uses a laser beam to scan areas inside the mouth and a computer collects information about the scan. The goal of this project is to train the computer software in the device to recognize pre-cancer and cancer from normal scans. Patients who need to have a biopsy due to suspected pre-cancer or cancer in the mouth will be scanned with the device. Biopsy reports will be used to tell the software which scans were from pre-cancer or cancer or non-cancer tissues. Volunteers with healthy oral tissue will be included to further test the computer software. Secondary aims include collecting pilot safety data and feedback regarding the use of this device. If successful, the results from this pilot study will lead to a bigger trial to further study how the device can be used for cancer diagnosis.

Conditions

  • Oral Cancer
  • Dysplasia
  • Oral Lesions
  • Oral Pre-cancer
  • Mouth Cancer

Interventions

DEVICE

LIP device

The LIP device uses polarized Raman spectroscopy to enhance the early detection and diagnosis of oral cancer by facilitating more accurate guiding of biopsies. This non-invasive technology utilizes polarized laser light to generate Raman scattering that can be used to analyze molecular vibrations, which in the future will provide clinicians with insights into tissue composition and structure for identifying cancerous abnormalities.

Sponsors & Collaborators

Principal Investigators

  • Mads Bergholt, PhD · King's College London

  • Richard J Cook, PhD, MRCSEd, MBChB, FDS RCS · King's College London

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07110623 on ClinicalTrials.gov