Endometrial Cancer Clinical Trial
Official title:
Pilot Study: Can the iKnife (Rapid Evaporative Ionisation Mass Spectrometry) Distinguish Between Normal and Malignant Endometrial Tissue?
Verified date | June 2020 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | June 1, 2020 |
Est. primary completion date | June 20, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Queen Charlotte and Hammersmith Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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) |
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