Colorectal NeoplasmsNCT05575765
Clinical Validation of Multimodal Digestive Endoscopy
An observational study of Colorectal Neoplasms and Confocal Laser Endomicroscopy, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
According to the latest global cancer epidemiological data published by the International Agency for Research on Cancer, colorectal cancer (CRC) ranks 3rd in total incidence and 2nd in total mortality among all malignancies worldwide. The prognosis of CRC is directly related to tumor stage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Neoplasms, Confocal Laser Endomicroscopy, Endoscopy, Digestive System
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2022to 10 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: grade III A hospital
Who may be able to join
- Age >18 years old.
- Clinical diagnosis of colorectal cancer, colorectal polyps, colorectal adenomas and enteritis.
- No allergy to relevant imaging agents.
- Person who is able to understand and sign the informed consent form.
- Person who is willing to participate in this experiment.
Who cannot join
- Patient who has been treated for colorectal lesions (endoscopic treatment, surgery , targeted therapy, and radiotherapy, etc.)
- Patients with severe, progressive, or uncontrolled diseases of the kidneys, liver, blood, gastrointestinal tract, endocrine system, lungs, heart, or nervous system.
- Women who are pregnant or breastfeeding.
- Person without personal freedom and independent civil capacity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Validation of Multimodal Digestive Endoscopy in the Diagnosis of Colorectal Lesions
According to the latest global cancer epidemiological data published by the International Agency for Research on Cancer, colorectal cancer (CRC) ranks 3rd in total incidence and 2nd in total mortality among all malignancies worldwide. The prognosis of CRC is directly related to tumor stage. The 5-year survival rate for early CRC can reach 90%, while less than 14% for advanced CRC. Therefore, early diagnosis of CRC is particularly important. Gastrointestinal (GI) endoscopy is an important method in the diagnosis of CRC. Currently, diagnosis of GI endoscopy is mainly based on morphological changes of tumors, while early-stage tumors are difficult to be detected because of the indistinguishable morphology. Studies have shown that the molecular function of cancer cells can be altered in early-stage tumors. The development of a new endoscopic system that can identify early tumor molecular function changes and improve the accuracy of morphological diagnosis will greatly improve the early diagnosis rate of CRC, which is the future direction of GI endoscopic system design and development.
The combination of high-definition white light endoscopy, endoscopic cerenkov luminescence imaging (ECLI) and probe-based confocal laser endomicroscopy (pCLE) is ideal for future new GI endoscopy. High-definition white light endoscopy is helpful to quickly find and locate suspected abnormal mucosa; on top of this, ECLI enables molecule-specific functional imaging for accurate identification and determination of GI lesions; and further relies on pCLE for high-precision "cellular-level" lesion images for optical biopsy of lesions. Through the multimodal digestive endoscopy, structural imaging and functional imaging can be accomplished simultaneously, playing the innate advantage of multimodal information fusion diagnosis and facilitating the identification of early-stage tumors.
In this clinical trial, patients with colorectal lesions who underwent PET-CT in Xijing Hospital were enrolled. Multimodal digestive endoscopy, combination of high-definition white light endoscopy, ECLI and pCLE, was used to perform for each patient's colorectal lesion. ECLI images were compared with PET-CT images, and pCLE images were compared with lesion histopathology, which evaluate the actual imaging effect of multimodal digestive endoscopy in human.
- Conditions
- Colorectal Neoplasms, Confocal Laser Endomicroscopy, Endoscopy, Digestive System, Molecular Imaging
- Keywords
- Probe-based confocal laser endomicroscopy, Endoscopic cerenkov luminescence imaging, Multimodal digestive endoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a clinical diagnosis of colorectal cancer, colorectal polyps, and colorectal adenomas | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concordance rate between the results of multimodal digestive endoscopy for the diagnosis of early colorectal malignancies and the histopathological results
Measured: White light endoscopy takes 1 second; endoscopic cerenkov luminescence imaging takes 5 minutes; probe-based confocal laser endomicroscopy takes 2 minutes
Secondary outcomes (1)
The concordance rate between the results of endoscopic cerenkov luminescence imaging for the diagnosis of early colorectal malignancies and the histopathological results
Measured: Endoscopic cerenkov luminescence imaging time: 1-5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start11 Nov 2022
- Primary completion10 Apr 2025 (estimated)
- Study completion10 Apr 2025 (estimated)
Why it stopped: At present, this exploratory study has preliminarily achieved the set goals, and the subsequent data analysis is currently underway to determine whether it is necessary to continue recruiting participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaichun Wu, Xijing Hospital of Digestive Diseases
- Investigators
- Wu kaichun, PhD, Study director, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575765
- Sponsor's protocol ID
- XijingMDERC
- Status last verified
- Mar 2025
- First submitted
- 30 Sep 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen X, Wang X, Yan T, Zheng Y, Cao H, Ren F, Cao X, Meng X, Lu X, Liang S, Wu K. Sensitivity improved Cerenkov luminescence endoscopy using optimal system parameters. Quant Imaging Med Surg. 2022 Jan;12(1):425-438. doi: 10.21037/qims-21-373.
PubMed 34993091Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Schillaci O, Scimeca M, Toschi N, Bonfiglio R, Urbano N, Bonanno E. Combining Diagnostic Imaging and Pathology for Improving Diagnosis and Prognosis of Cancer. Contrast Media Mol Imaging. 2019 Jul 1;2019:9429761. doi: 10.1155/2019/9429761. eCollection 2019.
PubMed 31354394Moghbeli M. MicroRNAs as the critical regulators of Cisplatin resistance in ovarian cancer cells. J Ovarian Res. 2021 Sep 30;14(1):127. doi: 10.1186/s13048-021-00882-1.
PubMed 34593006Fan X, Qin X, Zhang Y, Li Z, Zhou T, Zhang J, You W, Li W, Pan K. Screening for gastric cancer in China: Advances, challenges and visions. Chin J Cancer Res. 2021 Apr 30;33(2):168-180. doi: 10.21147/j.issn.1000-9604.2021.02.05.
PubMed 34158737Luu XQ, Lee K, Jun JK, Suh M, Jung KW, Choi KS. Effect of gastric cancer screening on long-term survival of gastric cancer patients: results of Korean national cancer screening program. J Gastroenterol. 2022 Jul;57(7):464-475. doi: 10.1007/s00535-022-01878-4. Epub 2022 May 14.
PubMed 35568752Hamashima C, Goto R. Potential capacity of endoscopic screening for gastric cancer in Japan. Cancer Sci. 2017 Jan;108(1):101-107. doi: 10.1111/cas.13100. Epub 2016 Dec 12.
PubMed 27727490Cao X, Chen X, Kang F, Lin Y, Liu M, Hu H, Nie Y, Wu K, Wang J, Liang J, Tian J. Performance evaluation of endoscopic Cerenkov luminescence imaging system: in vitro and pseudotumor studies. Biomed Opt Express. 2014 Sep 17;5(10):3660-70. doi: 10.1364/BOE.5.003660. eCollection 2014 Oct 1.
PubMed 25360380Hu H, Cao X, Kang F, Wang M, Lin Y, Liu M, Li S, Yao L, Liang J, Liang J, Nie Y, Chen X, Wang J, Wu K. Feasibility study of novel endoscopic Cerenkov luminescence imaging system in detecting and quantifying gastrointestinal disease: first human results. Eur Radiol. 2015 Jun;25(6):1814-22. doi: 10.1007/s00330-014-3574-2. Epub 2015 Jan 11.
PubMed 25577521Yang Z, Wu Z, Pang T, Liu D, Wang X, Yu J, Xu S, Kang X, Liao D, Tian Z, Bai Y, Xi X, Yan T, Lu X, Qi Y, Zhang M, Zhao L, Kang F, Liang S, Wang J, Chen X, Wu K. Early diagnosis of colorectal cancer using Cerenkov luminescence endoscopy: a pilot trial involving humans for the first time. Theranostics. 2026 Jan 8;16(7):3685-3696. doi: 10.7150/thno.122007. eCollection 2026.
PubMed 41608582
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of Multimodal Digestive Endoscopy in the Diagnosis of Colorectal Lesions
- ClinicalTrials.gov ID
- NCT05575765
- Acronym / sponsor ID
- XijingMDERC
- Conditions
- Colorectal Neoplasms, Confocal Laser Endomicroscopy, Endoscopy, Digestive System, Molecular Imaging
- Keywords
- Probe-based confocal laser endomicroscopy, Endoscopic cerenkov luminescence imaging, Multimodal digestive endoscopy
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: At present, this exploratory study has preliminarily achieved the set goals, and the subsequent data analysis is currently underway to determine whether it is necessary to continue recruiting participants.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to the latest global cancer epidemiological data published by the International Agency for Research on Cancer, colorectal cancer (CRC) ranks 3rd in total incidence and 2nd in total mortality among all malignancies worldwide. The prognosis of CRC is directly related to tumor stage. The 5-year survival rate for early CRC can reach 90%, while less than 14% for advanced CRC. Therefore, early diagnosis of CRC is particularly important. Gastrointestinal (GI) endoscopy is an important method in the diagnosis of CRC. Currently, diagnosis of GI endoscopy is mainly based on morphological changes of tumors, while early-stage tumors are difficult to be detected because of the indistinguishable morphology. Studies have shown that the molecular function of cancer cells can be altered in early-stage tumors. The development of a new endoscopic system that can identify early tumor molecular function changes and improve the accuracy of morphological diagnosis will greatly improve the early diagnosis rate of CRC, which is the future direction of GI endoscopic system design and development.
The combination of high-definition white light endoscopy, endoscopic cerenkov luminescence imaging (ECLI) and probe-based confocal laser endomicroscopy (pCLE) is ideal for future new GI endoscopy. High-definition white light endoscopy is helpful to quickly find and locate suspected abnormal mucosa; on top of this, ECLI enables molecule-specific functional imaging for accurate identification and determination of GI lesions; and further relies on pCLE for high-precision "cellular-level" lesion images for optical biopsy of lesions. Through the multimodal digestive endoscopy, structural imaging and functional imaging can be accomplished simultaneously, playing the innate advantage of multimodal information fusion diagnosis and facilitating the identification of early-stage tumors.
In this clinical trial, patients with colorectal lesions who underwent PET-CT in Xijing Hospital were enrolled. Multimodal digestive endoscopy, combination of high-definition white light endoscopy, ECLI and pCLE, was used to perform for each patient's colorectal lesion. ECLI images were compared with PET-CT images, and pCLE images were compared with lesion histopathology, which evaluate the actual imaging effect of multimodal digestive endoscopy in human.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a clinical diagnosis of colorectal cancer, colorectal polyps, and colorectal adenomas | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- grade III A hospital
Key inclusion criteria (5 listed)
- Age >18 years old.
- Clinical diagnosis of colorectal cancer, colorectal polyps, colorectal adenomas and enteritis.
- No allergy to relevant imaging agents.
- Person who is able to understand and sign the informed consent form.
- Person who is willing to participate in this experiment.
Key exclusion criteria (4 listed)
- Patient who has been treated for colorectal lesions (endoscopic treatment, surgery , targeted therapy, and radiotherapy, etc.)
- Patients with severe, progressive, or uncontrolled diseases of the kidneys, liver, blood, gastrointestinal tract, endocrine system, lungs, heart, or nervous system.
- Women who are pregnant or breastfeeding.
- Person without personal freedom and independent civil capacity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The concordance rate between the results of multimodal digestive endoscopy for the diagnosis of early colorectal malignancies and the histopathological results
Time frame: White light endoscopy takes 1 second; endoscopic cerenkov luminescence imaging takes 5 minutes; probe-based confocal laser endomicroscopy takes 2 minutes
1 secondary outcome
The concordance rate between the results of endoscopic cerenkov luminescence imaging for the diagnosis of early colorectal malignancies and the histopathological results
Time frame: Endoscopic cerenkov luminescence imaging time: 1-5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Background: PubMed 34993091Chen X, Wang X, Yan T, Zheng Y, Cao H, Ren F, Cao X, Meng X, Lu X, Liang S, Wu K. Sensitivity improved Cerenkov luminescence endoscopy using optimal system parameters. Quant Imaging Med Surg. 2022 Jan;12(1):425-438. doi: 10.21037/qims-21-373.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 31354394Schillaci O, Scimeca M, Toschi N, Bonfiglio R, Urbano N, Bonanno E. Combining Diagnostic Imaging and Pathology for Improving Diagnosis and Prognosis of Cancer. Contrast Media Mol Imaging. 2019 Jul 1;2019:9429761. doi: 10.1155/2019/9429761. eCollection 2019.
- Background: PubMed 34593006Moghbeli M. MicroRNAs as the critical regulators of Cisplatin resistance in ovarian cancer cells. J Ovarian Res. 2021 Sep 30;14(1):127. doi: 10.1186/s13048-021-00882-1.
- Background: PubMed 34158737Fan X, Qin X, Zhang Y, Li Z, Zhou T, Zhang J, You W, Li W, Pan K. Screening for gastric cancer in China: Advances, challenges and visions. Chin J Cancer Res. 2021 Apr 30;33(2):168-180. doi: 10.21147/j.issn.1000-9604.2021.02.05.
- Background: PubMed 35568752Luu XQ, Lee K, Jun JK, Suh M, Jung KW, Choi KS. Effect of gastric cancer screening on long-term survival of gastric cancer patients: results of Korean national cancer screening program. J Gastroenterol. 2022 Jul;57(7):464-475. doi: 10.1007/s00535-022-01878-4. Epub 2022 May 14.
- Background: PubMed 27727490Hamashima C, Goto R. Potential capacity of endoscopic screening for gastric cancer in Japan. Cancer Sci. 2017 Jan;108(1):101-107. doi: 10.1111/cas.13100. Epub 2016 Dec 12.
- Background: PubMed 25360380Cao X, Chen X, Kang F, Lin Y, Liu M, Hu H, Nie Y, Wu K, Wang J, Liang J, Tian J. Performance evaluation of endoscopic Cerenkov luminescence imaging system: in vitro and pseudotumor studies. Biomed Opt Express. 2014 Sep 17;5(10):3660-70. doi: 10.1364/BOE.5.003660. eCollection 2014 Oct 1.
- Background: PubMed 25577521Hu H, Cao X, Kang F, Wang M, Lin Y, Liu M, Li S, Yao L, Liang J, Liang J, Nie Y, Chen X, Wang J, Wu K. Feasibility study of novel endoscopic Cerenkov luminescence imaging system in detecting and quantifying gastrointestinal disease: first human results. Eur Radiol. 2015 Jun;25(6):1814-22. doi: 10.1007/s00330-014-3574-2. Epub 2015 Jan 11.
- Derived from this study: PubMed 41608582Yang Z, Wu Z, Pang T, Liu D, Wang X, Yu J, Xu S, Kang X, Liao D, Tian Z, Bai Y, Xi X, Yan T, Lu X, Qi Y, Zhang M, Zhao L, Kang F, Liang S, Wang J, Chen X, Wu K. Early diagnosis of colorectal cancer using Cerenkov luminescence endoscopy: a pilot trial involving humans for the first time. Theranostics. 2026 Jan 8;16(7):3685-3696. doi: 10.7150/thno.122007. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wu kaichun, PhD study director
Xijing Hospital of Digestive Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms and Confocal Laser Endomicroscopy, run by Xijing Hospital of Digestive Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concordance rate between the results of multimodal digestive endoscopy for the diagnosis of early colorectal malignancies and the histopathological results (time frame: White light endoscopy takes 1 second; endoscopic cerenkov luminescence imaging takes 5 minutes; probe-based confocal laser endomicroscopy takes 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05575765, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.