Clinical trial · Interventional
Can the iKnife Distinguish Between Normal and Malignant Endometrial Tissue?
Pilot Study: Can the iKnife (Rapid Evaporative Ionisation Mass Spectrometry) Distinguish Between Normal and Malignant Endometrial Tissue?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Endometrial Diseases | — | UNRESOLVED | — |
| Endometrial Hyperplasia | — | UNRESOLVED | — |
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iKnife i.e. Rapid Evaporative Ionisation Mass Spectrometry | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- All patients
- description
- Single study arm. All patients who participate in the study will receive conventional histological diagnosis and diagnosis with the new technology (iKnife)
- interventionNames
- Diagnostic Test: iKnife i.e. Rapid Evaporative Ionisation Mass Spectrometry
Primary outcomes (1)
- measure
- Diagnostic Ability of iKnife (REIMS) in Detection of Cancer and Pre-cancer in Endometrial Biopsy Specimens
- timeFrame
- 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)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available