Can the iKnife Distinguish Between Normal and Malignant Endometrial Tissue?

NCT03207074 | Completed Results

• 1 other identifier: 16HH3687 iKnife EC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Neoplasms; Endometrial Cancer; Endometrial Hyperplasia; Endometrial Diseases

Keywords

iKnife; Mass Spectrometry; Point-of-care; Diagnosis; Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

All patients

OTHER

Single study arm. All patients who participate in the study will receive conventional histological diagnosis and diagnosis with the new technology (iKnife)

Diagnostic Test: iKnife i.e. Rapid Evaporative Ionisation Mass Spectrometry

Interventions

iKnife i.e. Rapid Evaporative Ionisation Mass Spectrometry DIAGNOSTIC_TEST

The endometrial tissue will be analysed by this new technology and compared to gold standard (histopathology)

All patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study is looking at endometrial cancer so recruitment of women only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All women presenting to rapid access gynaecology clinic with postmenopausal bleeding or intermenstrual bleeding or referred with a confirmed diagnosis of endometrial cancer.

You may not qualify if:

• Anyone lacking capacity. \<18years old. Pregnant.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Queen Charlotte and Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Endometrial Hyperplasia; Uterine Diseases; Disease

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Diana Marcus
• Organization: Imperial College London

d.marcus16@imperial.ac.uk

07525133957

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 2, 2017
• Study Start: June 13, 2017
• Primary Completion: June 20, 2019
• Study Completion: June 1, 2020
• Last Updated: July 14, 2020
• Results First Posted: July 14, 2020

Record last verified: 2020-06

Locations

GB (1)