At a glance
ClinicalIndex Comparison Record- ✓Women presenting to rapid access gynaecology clinic with postmenopausal bleeding or intermenstrual bleeding
- ✓Women referred with a confirmed diagnosis of endometrial cancer
- ✕Lack capacity to consent
- ✕Age <18 years
- ✕Pregnant
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pilot Study: Can the iKnife (Rapid Evaporative Ionisation Mass Spectrometry) Distinguish Between Normal and Malignant Endometrial Tissue?
In Brief
A clinical study evaluating iKnife i.e. Rapid Evaporative Ionisation Mass Spectrometry for Endometrial Neoplasms and 3 related conditions. Completed, enrolled 150 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
The endometrial tissue will be analysed by this new technology and compared to gold standard (histopathology)