NCT03207074

Can the iKnife Distinguish Between Normal and Malignant Endometrial Tissue?

Completed NA Results posted Last updated 14 July 2020

What this trial tests

NA trial testing iKnife i.e. Rapid Evaporative Ionisation Mass Spectrometry in Endometrial Neoplasms in 150 participants. Completed in 1 June 2020.

Timeline

13 June 2017

Primary endpoint
20 June 2019

1 June 2020

Quick facts

Lead sponsor	Imperial College London
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	150
Start date	13 June 2017
Primary completion	20 June 2019
Estimated completion	1 June 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

• iKnife i.e. Rapid Evaporative Ionisation Mass Spectrometry

Conditions studied

• Endometrial Neoplasms — all drugs for Endometrial Neoplasms →
• Endometrial Cancer — all drugs for Endometrial Cancer →
• Endometrial Hyperplasia — all drugs for Endometrial Hyperplasia →
• Endometrial Diseases — all drugs for Endometrial Diseases →

Sponsor

Imperial College London

Who can join

18 and older, female only, with Endometrial Neoplasms or Endometrial Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Diagnostic Ability of iKnife (REIMS) in Detection of Cancer and Pre-cancer in Endometrial Biopsy Specimens Primary · Each patient was assessed in clinic and the research biopsy was performed during the clinic visit. It was processed within 4 hours by the iKnife (or snap frozen and processed at a later date, within 3months)

Sensitivity, specificity and positive and negative predictive values will be obtained for this new technology compared to gold standard (histopathological exam). Test sensitivity is the ability of the iknife to correctly identify those with endometrial cancer (true positive rate). Test specificity is the ability of the iKnife to correctly identify those without endometrial cancer (true negative rate). Positive predictive value is the probability that patients with a positive iKnife test result truly have the disease. Negative predictive value is the probability that patients with a negativ

Sensitivity

Group	Value	95% CI
All Patients	79

Specificity

Group	Value	95% CI
All Patients	96

Positive Predictive value

Group	Value	95% CI
All Patients	93

Negative predictive value

Group	Value	95% CI
All Patients	86

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Biosensors: from personalised medicine to population health.
   · 2020 · PMID 32245652 · DOI 10.1016/j.ebiom.2020.102746