Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04869618 |
Other study ID # |
2021/2105 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 2021 |
Est. completion date |
March 2023 |
Study information
Verified date |
April 2021 |
Source |
Changi General Hospital |
Contact |
Chin Kimg Tan, MD |
Phone |
6788 8833 |
Email |
tan.chin.kimg[@]singhealth.com.sg |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Early detection and treatment of gastric premalignant lesion and early gastric cancer (EGC)
have been proposed to improve outcomes of gastric cancer. Gastric dysplasia is a premalignant
lesion and the penultimate stage in gastric carcinogenesis. On white light endoscopy (WLE),
it is difficult to distinguish gastric dysplasia and EGC from benign pathology such as
gastric intestinal metaplasia (GIM). Image enhanced endoscopy such as narrow-band imaging
(NBI) is recommended to improve characterization of suspicious gastric lesions detected on
WLE. Magnified-endoscopy with NBI (ME-NBI) have been shown to be superior to HD-WLE for
diagnosis of GIM and EGC. Data on gastric dysplasia is less robust. Ultimately, biopsy is
required to confirm diagnosis of gastric dysplasia/EGC. Gastric dysplasia can be classified
into low-grade dysplasia (LGD) or high-grade dysplasia (HGD). Biopsy sampling may not be
representative of the final histopathological grade of resected specimens and may under-stage
dysplasia. Thus, endoscopic resection (ER) is recommended for gastric dysplasia and EGC on
biopsy for diagnostic and therapeutic purpose. The current gap is to improve concordance of
endoscopic and histologic findings of gastric dysplasia and early gastric cancer. Raman
spectroscopy based artificial intelligence system (SPECTRA IMDx) was developed to provide an
objective method to identify patients with gastric premalignant lesions and EGC. SPECTRA IMDx
interrogate tissues at the cellular level and utilizes molecular information to provide
actionable information to endoscopist during gastroscopy. Studies on diagnostic performance
using Raman spectroscopy analysis devices have shown high sensitivity and specificity in
detection of gastric cancer and precancerous lesions compared to WLE. However, these studies
included few GIM, gastric dysplasia and gastric carcinoma. It is still unclear if Raman
spectroscopy outperforms WLE in diagnosis of gastric HGD and EGC. In addition, the Raman
spectroscopy algorithm is only able to characterize lesions into high risk (HGD/EGC) versus
low risk (GIM/LGD/Gastritis/Normal). It is also uncertain if this technology is able to
differentiate GIM and LGD. We plan to conduct a prospective trial to validate the diagnostic
accuracy of SPECTRA for prediction of gastric HGD and EGC prior to gastric ER. Hypothesis:
SPECTRA IMDx is able to differentiate higher risk lesions (HGD/EGC) from lower risk
tissue/lesion (GIM/LGD/Gastritis/Normal)
Description:
This is a prospective, single-centre study designed to evaluate the diagnostic performance of
SPECTRA IMDx for real-time characterisation of gastric dysplasia and early gastric cancer for
patients undergoing gastric endoscopic resection over a 24-month period.
Informed consent will be taken by the investigator before study enrolment. Subject
participation in this study will last only the duration of the gastric endoscopic resection
procedure and during surveillance gastroscopy. The duration of procedure may vary depending
on the technical difficulty of the endoscopic resection performed, the size and number of
suspicious lesions detected requiring biopsies. Subjects will not be required to make an
additional visit to the hospital for the study.
Pre-endoscopic preparation and endoscopic procedure All antiplatelets except aspirin and all
anticoagulants will be stopped before gastric endoscopic resection as per guideline.Full
blood count and coagulation panel will be checked within one month before procedure to ensure
no significant thrombocytopenia or coagulopathy. All patients on antiplatelets except aspirin
and anticoagulation will be instructed to stop medications before procedure to reduce risk of
bleeding.
All patients will be fasted and receive oral mucolytics prior to gastroscopy as per routine
practice. Intravenous antispasmodics with either buscopan or glucagon will be administered to
allow proper assessment of lesion prior to resection.
The Endoscopist will begin systemic examination of the stomach to inspect for presence of
concomitant suspicious lesions and to identify the target lesion with dysplasia for
endoscopic resection.
Once target lesion for ER is identified, the lesion is examined with HD-WLE followed by NBI.
The endoscopist will then classify the lesion as normal/Gastritis/GIM/LGD or HGD/early
gastric cancer based on HD-WLE and NBI. The endoscopic diagnosis is documented on the case
report form. Following that, SPECTRA IMDx probe will be inserted via the instrument channel
and placed in contact with the lesion first for evaluation of lesion followed by collection
of Raman spectroscopy signals. The SPECTRA IMDx system will detect the scattering light
signal from the lesion and classify the lesion as 'high-risk' or 'low-risk'. If there are
different risk classified on the same lesion, the highest grade of pathology will be
recorded. This result will be documented on case report form. This will be followed by
collection of Raman signals from gastric lesion.
Workflow for SPECTRA IMDx usage is divided into
1. Evaluation of lesion for comparison against histopathology:
2. Collection of Raman spectroscopy signals to differentiate between GIM, LGD, HGD and EGC
If additional suspicious lesions are identified during systematic examination of the
stomach which were not biopsied or detected during previous endoscopy, these lesions
will be first examined with HD-WLE followed by NBI. SPECTRA IMDx will be then be used to
classify the lesions before biopsy sampling/resection are carried out. Findings from
HD-WLE with M-NBI and SPECTRA IMDx will be documented in CRF as per above protocol. For
lesions that does not require resection, collection of Raman spectroscopy signals will
be collected by placing SPECTRA IMDx probe on lesion for 5 seconds at point of biopsy.
Following assessment of gastric lesions with SPECTRA IMDx, indigo-carmine chromoendoscopy
will be applied onto the lesion to delineate the lesions prior to endoscopic resection.
Endoscopist will document findings based on indigo-carmine chromoendoscopy on the case report
form. Endoscopic resection is then performed.
If the lesion is deemed not suitable for endoscopic resection due to size criteria or no
evidence of dysplasia based on HD-WLE and NBI with dye-based chromoendosocpy, biopsies will
be taken instead as per routine practice.
Any adverse events related to gastric endoscopic resection will be noted. The time taken for
examination using HD-WLE and NBI, gastric endoscopic resection and overall procedure time
will be recorded.
Surveillance endoscopy is usually performed within six months to a year following gastric
endoscopic resection to ensure no recurrence. During surveillance endoscopy, endoscopic
resection site and any suspicious lesions will be examined sequentially with HD-WLE, M-NBI
and lastly SPECTRA IMDx (first for evaluation of lesion, followed by collection of Raman
spectroscopy signals. Findings will be documented in CRF before biopsy sample(s) are taken.
For all patients, resection specimens (or biopsy specimens in cases where endoscopic
resections are not performed) will be fixed in formalin and sent for histopathological
evaluation. A specialized gastrointestinal pathologist will examine the resection specimen
and/or biopsy sample(s) and provide a histopathological diagnosis for the lesion as part of
patient routine care. The result will be recorded in case report form. The reporting
pathologist will be blinded to SPECTRA IMDX and HD-WLE with M-NBI assessment.
The endoscopic diagnosis of SPECTRA results and HD-WLE (with and without NBI) will be
compared against the final histopathological results. Acquired Raman spectroscopy signals
will be also be analysed to improve diagnostic algorithm of SPECTRA in differentiating GIM,
LGD, HGD, ECG and scar tissue after correlation with histopathological specimen.