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Can the iKnife Distinguish Between Normal and Malignant Endometrial Tissue?

NCT03207074 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-07-14

Study results available
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Summary

Aim: Determine if Rapid Evaporative Ionization Mass Spectrometry (the iKnife); can diagnose cancer and pre-cancer from endometrial tissue biopsy samples.

Women attending a gynaecology clinic for assessment of abnormal bleeding will receive an pelvic (internal) ultrasound as routine standard of care. If any abnormalities are detected, a tissue sample will be needed. If women are agreeable a second tissue sample will be taken for research. The first will be analysed by conventional means (histopathology). The second sample with new technology called the 'iKnife'. This is a modified type of Mass spectrometry device, that separates particles based on their mass charge ratio. The idea being that if tissue is burnt, gas is produced, and this gas contains lots of ions that can be analysed by the iKnife. Each type of tissue (cancer or non-cancer) will have a unique signature that the iKnife can use to distinguish between samples. If effective it could be used in future outpatient clinics to provide a one-stop, true point of care diagnosis.

Conditions

Interventions

DIAGNOSTIC_TEST

iKnife i.e. Rapid Evaporative Ionisation Mass Spectrometry

The endometrial tissue will be analysed by this new technology and compared to gold standard (histopathology)

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-13
Primary Completion
2019-06-20
Completion
2020-06-01

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT03207074 on ClinicalTrials.gov