The primary objective of the study is to assess the diagnostic performance of the endoscopist performing a MAGENTIQ-COLO CADx-assisted colonoscopy to classify polyps as diminutive (5mm) compared to size classification using open biopsy forceps, or…
ID
Source
Brief title
Condition
- Benign neoplasms gastrointestinal
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The diagnostic performance of the CADx-assisted optical diagnosis to correctly
classify colorectal polyps as diminutive (<=5mm) or non-diminutive (>5mm). This
will be measured by the sensitivity and specificity of the CADx-assisted
optical diagnosis compared to the size classification of the polyp using open
biopsy forceps, or polypectomy snare, of known diameter.
Secondary outcome
- The diagnostic performance of high-confidence CADx-assisted optical diagnosis
to correctly identify diminutive colorectal polyps as neoplastic (adenoma or
SSL). This will be measured by the sensitivity and specificity of the
CADx-assisted optical diagnosis compared to the reference standard pathology
diagnosis.
- The ability of the CADx-assisted optical diagnosis to correctly assign
post-polypectomy surveillance intervals. This will be measured by the agreement
rate of high-confidence CADx-assisted optical diagnosis for polyps <=5mm (cutoff
based on the reference gold standard of this study) combined with the
pathological diagnosis for polyps >5mm
- The diagnostic performance of CADx-assisted optical diagnosis to correctly
identify diminutive polyps in the rectosigmoid as neoplastic. This will be
measured by the negative predictive value (NPV) of the high-confidence
CADx-assisted optical diagnosis ompared to the reference standard pathology
diagnosis.
-The rate of high-confidence neoplastic diagnoses (size and optical diagnosis)
of diminutive colorectal polyps between standard visual inspection, the CADx
system diagnosis, and CADx-assisted optical diagnosis.
Background summary
Colonoscopy is the gold standard for the detection and removal ofdetecting and
removing premalignant colorectal polyps. Recommended post-polypectomy
surveillance intervals are primarily based on pathological diagnosis and polyp
size. However, accurate estimation of polyp size remains challenging,
potentially influencing post-polypectomy surveillance intervals. Inaccuracies
in size estimation may lead to either unnecessary or prematurely scheduled
surveillance colonoscopies when overestimating size or lead to an increased
risk of post-colonoscopy colorectal cancer or advanced neoplasia when
underestimating size. Furthermore, diminutive (1-5mm) polyps pose challenges
due to their high incidence and frequent pathological assessment. Proposed
strategies to reduce this burden, such as the European Society of
Gastrointestinal Endoscopy (ESGE) *resect-and-discard' strategy, are
infrequently used as non-expert endoscopists often do not meet diagnostic
thresholds when using standard visual inspection. The MAGENTIQ-COLO
computer-aided diagnosis (CADx) system by Magentiq Eye LTD, Haifa, Israel,
addresses these challenges by providing real-time size estimation and polyp
characterization.
Study objective
The primary objective of the study is to assess the diagnostic performance of
the endoscopist performing a MAGENTIQ-COLO CADx-assisted colonoscopy to
classify polyps as diminutive (<=5mm) or non-diminutive (>5mm) compared to size
classification using open biopsy forceps, or polypectomy snare, of known
diameter. This will be measured by comparing the sensitivity and specificity
between the two size classifications.
Secondary objectives include:
-To assess the diagnostic performance of the endoscopist performing a
MAGENTIQ-COLO CADx-assisted colonoscopy to diagnose diminutive (rectosigmoid)
colorectal polyps as neoplastic (adenoma or SSL) with high-confidence compared
to the pathology diagnosis. This will be measured by the sensitivity and
specificity between the two diagnoses;
- To assess whether performing a MAGENTIQ-COLO CADx-assisted colonoscopy meets
the PIVI-1 and PIVI-2 criteria for real-time endoscopic assessment of the
histology of diminutive colorectal polyps as proposed by the American Society
for Gastrointestinal Endoscopy (ASGE).
o PIVI-1 criterium: >=90% agreement in assigning ASGE post-polypectomy
surveillance intervals. This assessment is based on the high-confidence
CADx-assisted optical diagnosis by the endoscopist for polyps <=5mm (cutoff
based on the reference polyp size standard) in combination with pathological
assessment for polyps >5mm. The comparator is the post-polypectomy surveillance
intervals based on the pathological diagnosis of all identified polyps.
o PIVI-2 criterium: >=90% negative predictive value of the high-confidence
CADx-assisted optical diagnosis of diminutive rectosigmoid polyps as neoplastic
(adenoma or SSL) compared to pathological diagnosis.
- To assess the rate of high-confidence optical diagnoses (size and pathology)
of using MAGENTIQ-COLO compared to the rate of high-confidence optical
diagnoses using standard visual inspection.
*
Study design
This is an international, multicenter, prospective study to evaluate diagnostic
performance compared to a reference standard
Intervention
CADx-geassisteerde colonoscopie
Study burden and risks
The risk of (serious) adverse events associated with MAGENTIQ-COLO-assisted
colonoscopy is comparable to that of conventional colonoscopy, as determined in
our prior randomized, controlled trial. Although the described study procedures
may lead to slightly prolonged colonoscopy procedural times compared to
conventional methods, it is anticipated that patients will derive benefits from
MAGENTIQ-COLO-assisted colonoscopy. Our aforementioned previous trial
demonstrated a notable 37% increase in adenoma detection with the use of the
MAGENTIQ-COLO (Maas, M. et al. (2024) Lancet Digital Health).
Sderot Ben Gurion 6
Haifa 3541416
IL
Sderot Ben Gurion 6
Haifa 3541416
IL
Listed location countries
Age
Inclusion criteria
Individuals aged >=45 - <=80 years old, who are scheduled for non-iFOBT screening
or surveillance colonoscopy.
Exclusion criteria
. In situ polyps with known histology.
2. No colorectal polyps detected during colonoscopy.
3. Known or suspected Inflammatory bowel disease.
4. Polyposis syndrome (e.g., familial adenomatous polyposis, serrated
polyposis).
5. Non-hereditary polyposis syndromes (e.g. Lynch syndrome).
6. History of chemotherapy or radiation therapy for colorectal lesions.
7. Pregnancy.
8. Has a referral for therapeutic procedure (i.e., endoscopic mucosal
resection, intervention to stop a lower gastro-intestinal bleeding, etc.).
9. Inability to undergo polypectomy (e.g., incorrect continued use of
anticoagulants, comorbidities) or patient refusal, as assessed by the
endoscopist.
10. Inability to provide informed consent.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06568523 |
| CCMO | NL86897.078.24 |