Real-life Prospective Evaluation of Computer-aided Detection (CAD) of Barrett's Neoplasia (MetaVision)
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ClinicalTrials.gov Identifier: NCT05965921 |
Recruitment Status :
Recruiting
First Posted : July 28, 2023
Last Update Posted : November 18, 2023
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Barrett's oesophagus is a pre-cancerous condition in which normal cells in the lining of gullet undergo cell changes and this increases the risk of developing adenocarcinoma (a type of cancer) of the gullet. This type of cancer is the 5th most common type of cancer in the UK. To minimise this risk of developing cancer, patients with Barret's oesophagus have regular gastroscopy (a small camera at the tip of the slim tube) every 2-5 years to detect early cancer cell changes. During the procedure, the whole of oesophagus is carefully inspected, and small tissue samples (biopsies) are taken from visible abnormal area within Barrett's oesophagus and sent to the lab to check for cell changes. This is called targeted biopsies. As the endoscopist cannot always tell during gastroscopy where cells are changing, biopsies from each quarter of the gullet (called quadrantic biopsies) are also taken to reduce the risk of pre-cancerous cells being missed. However, this process is time consuming and expensive as numerous biopsies are required.
Recently, there has been a huge development in artificial intelligence (AI). One of these developments is the aid of computer to detect (called computer-aided detection - CAD) the abnormal cell changes within Barrett's during gastroscopy. This system has recently been trained and tested on videos and photos to prove that its performance is as good as expert endoscopists. This system has been already approved to use in the UK. However, this system needs to be tested further and incorporated into real life use to prove that the CAD is useful in detecting cell changes during gastroscopy for targeted biopsies and therefore, the random biopsies can be avoided.
A sample of patients with Barrett's oesophagus will be invited to participate in this study. Participants will have a gastroscopy as part of their usual care for Barrett's oesophagus. Endoscopist will inspect Barrett's oesophagus using AI and will take both targeted biopsies if clinically deemed appropriate along with quadrantic biopsies. Participants will continue to receive usual care and no additional follow up or procedures will be required as part of the study.
Condition or disease |
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Gastroscopy Barrett's Esophagus |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 127 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 2 Months |
Official Title: | Real-life Prospective Evaluation of Computer-aided Detection (CAD) of Barrett's Neoplasia: MetaVision Study |
Actual Study Start Date : | July 26, 2023 |
Estimated Primary Completion Date : | November 2024 |
Estimated Study Completion Date : | January 2025 |
Group/Cohort |
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Barrett's oesophagus
Patients over 18 with known Barrett's oesophagus having gastroscopy for either surveillance or assessment of known Barrett's neoplasia
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- Number of additional Barrett's neoplasia found on quadrantic biopsies [ Time Frame: From enrolment to end of follow up at 2 month when histology results are available. ]The primary endpoint of the study is the number of additional neoplasia found on quadrantic biopsies. This will be collected and calculated from histology data of the targeted and quadrantic biopsies.
- Impact of AI (WISE VISION) in real-life [ Time Frame: From enrolment to end of follow up at 2 month when histology results are available. ]Number of neoplasia missed by WISE VISION® CAD system
- Impact of AI (WISE VISION) in real-life [ Time Frame: From enrolment to end of follow up at 2 month when histology results are available. ]Sensitivity of WISE VISION® CAD system
- Impact of AI (WISE VISION) in real-life [ Time Frame: From enrolment to end of follow up at 2 month when histology results are available. ]Specificity of WISE VISION® CAD system
- Impact of AI (WISE VISION) in real-life [ Time Frame: From enrolment to end of follow up at 2 month when histology results are available. ]Accuracy of WISE VISION® CAD system
- Impact of AI (WISE VISION) in real-life [ Time Frame: From enrolment to end of follow up at 2 month when histology results are available. ]Positive predictive value of WISE VISION® CAD system
- Impact of AI (WISE VISION) in real-life [ Time Frame: From enrolment to end of follow up at 2 month when histology results are available. ]Negative predictive value of WISE VISION® CAD system
- Impact of AI (WISE VISION) in real-life [ Time Frame: From enrolment to end of follow up at 2 month when histology results are available. ]Missed rate of WISE VISION® CAD system calculated from additional neoplasia on histology results of quadrantic biopsies.
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Any self-identified genders |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Anyone aged 18 years and above
- Known Barrett's oesophagus and having a gastroscopy for Barrett's surveillance or assessment of known neoplasia.
- Participant is willing and able to give informed consent for participation in the study
Exclusion Criteria:
- Recent ablation therapy (HALO, APC) to Barrett's oesophagus in the last 6 weeks
- Oesophageal disorder and patient's factors which impairs the ability of endoscopist to adequately assess of Barrett's neoplasia. This includes but not just limiting to severe oesophagitis, candidiasis, and poor patient tolerance.
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): NCT05965921
Contact: Hein Htet, MBBS | +44 23 9228 6000 ext +6929 | hein.htet@porthosp.nhs.uk | |
Contact: Laura Marshall | +44 23 9228 6000 ext 5455 | laura.marshall2@porthosp.nhs.uk |
United Kingdom | |
Queen Alexandra Hospital, Portsmouth Hospitals University NHS trust | Recruiting |
Portsmouth, Hampshire, United Kingdom, PO6 1LY | |
Contact: Michelle Baker-Moffatt +44 2392 286000 ext 5609 michelle.baker-moffatt@porthosp.nhs.uk |
Principal Investigator: | Pradeep Bhandari | Queen Alexandra Hospital, Portsmouth Hospitals University NHS Trust |
Responsible Party: | Portsmouth Hospitals NHS Trust |
ClinicalTrials.gov Identifier: | NCT05965921 |
Other Study ID Numbers: |
23/PR/0213 |
First Posted: | July 28, 2023 Key Record Dates |
Last Update Posted: | November 18, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Barrett's oesophagus Artificial intelligence Endoscopy |
Barrett Esophagus Neoplasms Precancerous Conditions |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |