Can the iKnife Distinguish Between Normal and Malignant Endometrial Tissue?
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|ClinicalTrials.gov Identifier: NCT03207074|
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : August 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Neoplasms Endometrial Cancer Endometrial Hyperplasia Endometrial Diseases||Diagnostic Test: iKnife i.e. Rapid Evaporative Ionisation Mass Spectrometry||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study: Can the iKnife (Rapid Evaporative Ionisation Mass Spectrometry) Distinguish Between Normal and Malignant Endometrial Tissue?|
|Actual Study Start Date :||June 13, 2017|
|Estimated Primary Completion Date :||June 20, 2019|
|Estimated Study Completion Date :||October 20, 2019|
Single study arm. All patients who participate in the study will recieve conventional histological diagnosis and diagnosis with the new technology (iKnife)
Diagnostic Test: iKnife i.e. Rapid Evaporative Ionisation Mass Spectrometry
The endometrial tissue will be analysed by this new technology and compared to gold standard (histopathology)
- Diagnostic ability of iKnife (REIMS) in detection of cancer and pre-cancer in endometrial biopsy specimens [ Time Frame: 2 years ]Sensitivity, specificity and positive and negative predictive values will be obtained for this new technology compared to gold standard (histopathological exam)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207074
|Contact: Diana Marcus, MB BS||020 7589 firstname.lastname@example.org|
|Contact: Sadaf Ghaem-Maghami, FRCOGemail@example.com|
|Queen Charlotte and Hammersmith Hospital||Recruiting|
|London, United Kingdom, W12 0HS|
|Contact: Diana Marcus, MB BS firstname.lastname@example.org|
|Principal Investigator: Zoltan Takats, PhD|
|Principal Investigator: Sadaf Ghaem-Maghami, MRCOG PhD|