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Can the iKnife Distinguish Between Normal and Malignant Endometrial Tissue?

NCT03207074CompletedNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

Imperial College London

Enrollment

150

Start Date

2017-06-13

Completion Date

2019-06-20

Study Type

INTERVENTIONAL

Official Title

Pilot Study: Can the iKnife (Rapid Evaporative Ionisation Mass Spectrometry) Distinguish Between Normal and Malignant Endometrial Tissue?

Interventions

iKnife i.e. Rapid Evaporative Ionisation Mass Spectrometry

Conditions

Endometrial NeoplasmsEndometrial CancerEndometrial HyperplasiaEndometrial Diseases

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* All women presenting to rapid access gynaecology clinic with postmenopausal bleeding or intermenstrual bleeding or referred with a confirmed diagnosis of endometrial cancer.

Exclusion Criteria:

* Anyone lacking capacity. \<18years old. Pregnant.

Outcome Measures

Primary Outcomes

Diagnostic Ability of iKnife (REIMS) in Detection of Cancer and Pre-cancer in Endometrial Biopsy Specimens

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 negative screening iKnife test truly don't have endometrial cancer.

Time frame: 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)

Locations

Queen Charlotte and Hammersmith Hospital, London, United Kingdom

Linked Diseases

Endometrial Neoplasms

Endometrial Neoplasms — a type of gynecological cancer.