N/A
N=150
Can the iKnife Distinguish Between Normal and Malignant Endometrial Tissue?
Endometrial Neoplasms · Endometrial Cancer · Endometrial Hyperplasia · Endometrial Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03207074 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Diagnostic Ability of iKnife (REIMS) in Detection of Cancer and Pre-cancer in Endometrial Biopsy Specimens — 79; 96; 93; 86 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- iKnife i.e. Rapid Evaporative Ionisation Mass Spectrometry (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Imperial College London
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Ability of iKnife (REIMS) in Detection of Cancer and Pre-cancer in Endometrial Biopsy Specimens |
79; 96; 93; 86 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03207074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.