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Can the iKnife Distinguish Between Normal and Malignant Endometrial Tissue?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03207074
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : August 9, 2018
Information provided by (Responsible Party):
Imperial College London

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
All patients
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)

Primary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study is looking at endometrial cancer so recruitment of women only
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03207074

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Contact: Diana Marcus, MB BS 020 7589 5111
Contact: Sadaf Ghaem-Maghami, FRCOG

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United Kingdom
Queen Charlotte and Hammersmith Hospital Recruiting
London, United Kingdom, W12 0HS
Contact: Diana Marcus, MB BS   
Principal Investigator: Zoltan Takats, PhD         
Principal Investigator: Sadaf Ghaem-Maghami, MRCOG PhD         
Sponsors and Collaborators
Imperial College London

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Responsible Party: Imperial College London Identifier: NCT03207074     History of Changes
Other Study ID Numbers: 16HH3687 iKnife EC
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Mass Spectrometry
Endometrial Cancer
Additional relevant MeSH terms:
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Endometrial Neoplasms
Endometrial Hyperplasia
Uterine Diseases
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Female