Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05965921
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-06-08
Brief Title:
Real-life Prospective Evaluation of Computer-aided Detection CAD of Barretts Neoplasia
Sponsor:
Portsmouth Hospitals NHS Trust
Organization:
Portsmouth Hospitals NHS Trust
Study Overview
Official Title:
Real-life Prospective Evaluation of Computer-aided Detection CAD of Barretts Neoplasia MetaVision Study
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MetaVision
Brief Summary:
Barretts 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 Barrets 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 Barretts 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 Barretts 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 Barretts oesophagus will be invited to participate in this study Participants will have a gastroscopy as part of their usual care for Barretts oesophagus Endoscopist will inspect Barretts 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
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 Barretts 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 Barretts oesophagus will be invited to participate in this study Participants will have a gastroscopy as part of their usual care for Barretts oesophagus Endoscopist will inspect Barretts 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
Detailed Description:
Barretts oesophagus is precursor to oesophageal adenocarcinoma and it affects 05-2 of the western population It has 05-3 risk of yearly progression to cancer from which 20 will survive at 5 years after diagnosis of cancer Diagnosing early cancer including dysplasia in Barretts oesophagus improves survival Current surveillance practice for Barretts neoplasia includes regular gastroscopy with careful inspection of Barretts mucosa along with quadrantic biopsies every 2 cm of Barretts length as per Seattle protocol This practice of non-targeted biopsies is labour intensive expensive and still misses neoplasia Recently multiple computer-aided detection CAD systems with the use of deep learning have been developed and validated in vitro studies to detect neoplasia However further real-life studies are required to determine the efficacy and practicality of CAD in detecting Barretts neoplasia
The investigators hypothesise that WISE VISION CAD system to detect Barretts neoplasia can improve the detection rate of targeted biopsies hence making protocol-guided biopsy unnecessary
Study Procedure
This will be a real-life prospective study using WISE VISION NEC Japan CAD system which is already validated and approved for use in the UK and EU Gastroscopy will be performed on Barretts oesophagus patients who are willing to participate for surveillance or assessment of neoplasia as per the clinical need
Necessary preparations to achieve a good mucosal view of oesophagus will be advised during procedure This may include the use mucolytic drink simeticone N-acetylcystine for mucosal toileting washing with a water jet and aspiration and the use of hyoscine butylbromide to reduce oesophageal contractions as it would be performed as a standard practice during routine gastroscopy
A quick white light imaging WLI withdrawal of endoscope will be done to ensure that all mucosa is clean and exposed If any obvious neoplastic lesion is detected by the endoscopist this will be noted down for future targeted biopsy
Next will be a WLI withdrawal with the WISE VISION CAD system to detect any neoplasia The withdrawal will be repeated with rotation of the endoscope 12 oclock position on the screen to 6 oclock position Areas detected by the CAD system will be biopsied as per endoscopists discretion and the endoscopist will be asked to make a call as to whether it is neoplasia or non-neoplasia Location of any targeted biopsies will be recorded This will be followed by protocol-guided quadrantic biopsies while avoiding repeat biopsies of previously targeted areas
Participants are expected to visit once for gastroscopy as a day case as part of their standard of care No additional visits are required The gastroscopy will be performed as per standard care and as detailed above WISE VISION CAD system is already in use in participating centres and this has become standard of care in these centres
Study population
This will be a multi-centre study led by Queen Alexandra Hospital QAH Portsmouth UK which is the Sponsor site The study population is enriched with known Barretts oesophagus who are undergoing surveillance or assessment of neoplasia in Barretts oesophagus The study population will include local patients and tertiary referrals received by QAH
This study will also be open to other external sites which have an organized Barretts endoscopy service and already use and are familiar with the WISE VISION CAD system
Statistical plan
The Chief Investigator of this study is highly experienced in developing and running endoscopy clinical trials including studies on the application of AI and CAD in endoscopy All co-investigators and members of the Sponsor site research team are GCP certified and have experience in running various endoscopy-based studies From clinical experience as a tertiary centre the investigators believe that the rate of neoplasia in enriched Barretts population at any tertiary referral centre would be around 25 Our preliminary video-based experience suggests that the sensitivity and specificity of CAD in detecting neoplasia in Barretts is around 90
The sample size is based on achieving a reasonably precise estimate of the percentage of patients in which neoplasia would be missed by AI and detected by multiple biopsies It is estimated that 5 of patients would have a missed neoplasia The sample size is based on obtaining an estimate of this outcome that is correct to within 6 of the population value deemed to be an acceptable level of uncertainty Using a 95 confidence level it is calculated that 51 patients with neoplasia are required It is estimated that only 40 of all recruited patients would have one or more neoplasia Thus in total it is proposed to recruit 127 patients in total into the study
Data collection
Patient data collected at baseline will include
Demographics ethnicity and occupation social and lifestyle factors smoking alcohol consumption
History of Barretts including date of first diagnosis of Barretts and subsequent treatments
Previous endoscopy and histology reports
Current relevant medications
The first part of the CRF will be completed before gastroscopy Consent can be withdrawn at any point Consent will be taken by delegated GCP certified research personnel after appropriate training has been completed and once deemed competent to take consent by the PI Patients who at this point decline consent will continue to have a standard gastroscopy on the research list which will not be part of the study Reason for decline will be collected and added to the screening log
Participants will attend hospital as outpatients for their gastroscopy Preparation for the procedure and all other activities and medications provided during the procedure will be carried out according to standard clinical practice except for the use of CAD system for detection prior to biopsy during gastroscopy
The following data will be recorded during gastroscopy
Duration of gastroscopy
Use of sedation
Length of Barretts using the Prague criteria
Presence absence and location of islands of Barretts distance in cm from incisor and clock face direction in endoscope neutral position
Presence of endoscopically visible inflammation
For targeted biopsies
Location size morphology optical diagnosis of each neoplastic area grade of dysplasia or cancer
CAD positive or negative
If positive agreementdisagreement with endoscopist to biopsy to rule out neoplasia
If not reason for disagreement counted as false positive
For quadrantic biopsies
Location of biopsies and indication of whether it is part of the neoplasia detected by AI andor endoscopist
Post procedure
After gastroscopy patients remain in standard care At this point all histology results from targeted and mapping biopsies will be processed and released as soon as possible This will result in a delay of a maximum of eight weeks for histology to become available Cancer is usually clinically obvious and it would be unlikely to be missed at gastroscopy during the study and where obvious invasive cancer is suspected samples will be sent as urgent and immediate referral for treatment made Unexpected cancer found in histopathology specimens would again result in immediate referral for treatment via the established NHS cancer pathways with the patient leaving the study Therefore clinical care would not be compromised
The investigators hypothesise that WISE VISION CAD system to detect Barretts neoplasia can improve the detection rate of targeted biopsies hence making protocol-guided biopsy unnecessary
Study Procedure
This will be a real-life prospective study using WISE VISION NEC Japan CAD system which is already validated and approved for use in the UK and EU Gastroscopy will be performed on Barretts oesophagus patients who are willing to participate for surveillance or assessment of neoplasia as per the clinical need
Necessary preparations to achieve a good mucosal view of oesophagus will be advised during procedure This may include the use mucolytic drink simeticone N-acetylcystine for mucosal toileting washing with a water jet and aspiration and the use of hyoscine butylbromide to reduce oesophageal contractions as it would be performed as a standard practice during routine gastroscopy
A quick white light imaging WLI withdrawal of endoscope will be done to ensure that all mucosa is clean and exposed If any obvious neoplastic lesion is detected by the endoscopist this will be noted down for future targeted biopsy
Next will be a WLI withdrawal with the WISE VISION CAD system to detect any neoplasia The withdrawal will be repeated with rotation of the endoscope 12 oclock position on the screen to 6 oclock position Areas detected by the CAD system will be biopsied as per endoscopists discretion and the endoscopist will be asked to make a call as to whether it is neoplasia or non-neoplasia Location of any targeted biopsies will be recorded This will be followed by protocol-guided quadrantic biopsies while avoiding repeat biopsies of previously targeted areas
Participants are expected to visit once for gastroscopy as a day case as part of their standard of care No additional visits are required The gastroscopy will be performed as per standard care and as detailed above WISE VISION CAD system is already in use in participating centres and this has become standard of care in these centres
Study population
This will be a multi-centre study led by Queen Alexandra Hospital QAH Portsmouth UK which is the Sponsor site The study population is enriched with known Barretts oesophagus who are undergoing surveillance or assessment of neoplasia in Barretts oesophagus The study population will include local patients and tertiary referrals received by QAH
This study will also be open to other external sites which have an organized Barretts endoscopy service and already use and are familiar with the WISE VISION CAD system
Statistical plan
The Chief Investigator of this study is highly experienced in developing and running endoscopy clinical trials including studies on the application of AI and CAD in endoscopy All co-investigators and members of the Sponsor site research team are GCP certified and have experience in running various endoscopy-based studies From clinical experience as a tertiary centre the investigators believe that the rate of neoplasia in enriched Barretts population at any tertiary referral centre would be around 25 Our preliminary video-based experience suggests that the sensitivity and specificity of CAD in detecting neoplasia in Barretts is around 90
The sample size is based on achieving a reasonably precise estimate of the percentage of patients in which neoplasia would be missed by AI and detected by multiple biopsies It is estimated that 5 of patients would have a missed neoplasia The sample size is based on obtaining an estimate of this outcome that is correct to within 6 of the population value deemed to be an acceptable level of uncertainty Using a 95 confidence level it is calculated that 51 patients with neoplasia are required It is estimated that only 40 of all recruited patients would have one or more neoplasia Thus in total it is proposed to recruit 127 patients in total into the study
Data collection
Patient data collected at baseline will include
Demographics ethnicity and occupation social and lifestyle factors smoking alcohol consumption
History of Barretts including date of first diagnosis of Barretts and subsequent treatments
Previous endoscopy and histology reports
Current relevant medications
The first part of the CRF will be completed before gastroscopy Consent can be withdrawn at any point Consent will be taken by delegated GCP certified research personnel after appropriate training has been completed and once deemed competent to take consent by the PI Patients who at this point decline consent will continue to have a standard gastroscopy on the research list which will not be part of the study Reason for decline will be collected and added to the screening log
Participants will attend hospital as outpatients for their gastroscopy Preparation for the procedure and all other activities and medications provided during the procedure will be carried out according to standard clinical practice except for the use of CAD system for detection prior to biopsy during gastroscopy
The following data will be recorded during gastroscopy
Duration of gastroscopy
Use of sedation
Length of Barretts using the Prague criteria
Presence absence and location of islands of Barretts distance in cm from incisor and clock face direction in endoscope neutral position
Presence of endoscopically visible inflammation
For targeted biopsies
Location size morphology optical diagnosis of each neoplastic area grade of dysplasia or cancer
CAD positive or negative
If positive agreementdisagreement with endoscopist to biopsy to rule out neoplasia
If not reason for disagreement counted as false positive
For quadrantic biopsies
Location of biopsies and indication of whether it is part of the neoplasia detected by AI andor endoscopist
Post procedure
After gastroscopy patients remain in standard care At this point all histology results from targeted and mapping biopsies will be processed and released as soon as possible This will result in a delay of a maximum of eight weeks for histology to become available Cancer is usually clinically obvious and it would be unlikely to be missed at gastroscopy during the study and where obvious invasive cancer is suspected samples will be sent as urgent and immediate referral for treatment made Unexpected cancer found in histopathology specimens would again result in immediate referral for treatment via the established NHS cancer pathways with the patient leaving the study Therefore clinical care would not be compromised
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None