Colon CancerNCT02324374
Endocytoscopy and Colorectal Neoplasia
A study testing Endocystoscopy During Colonoscopy and Endocytoscope in people with Colon Cancer, run by University of Pennsylvania at 1 site in United States.
Trial summary
This will be a feasibility study to evaluate the role of endocytoscopy in classifying colorectal polyps in vivo. The primary outcomes will be to determine the key endocytoscopy image features of neoplastic and non-neoplastic colorectal polyps. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Endocystoscopy During Colonoscopy and Endocytoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jan 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above 18, any patient undergoing screening or surveillance colonoscopy.
Who cannot join
- Pregnancy
- Unwillingness to consent
- Lack of any pathological state that would require biopsy at the time of endoscopy (will be considered "screen failure" since this will not be known until after consent is obtained and sedated endoscopy performed).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Role of in Vivo Real Time Endocytoscopy in Diagnosing Colorectal Neoplasia
This will be a feasibility study to evaluate the role of endocytoscopy in classifying colorectal polyps in vivo. The primary outcomes will be to determine the key endocytoscopy image features of neoplastic and non-neoplastic colorectal polyps. The target population will include adult subjects undergoing screening and surveillance colonoscopies.
Read the detailed description
Colorectal cancer has been recognized as the second most common cause of cancer related death in the US (1). Most colorectal cancers arise from adenomatous polyps that progress. Colon polyps are usually classified as neoplastic (adenoma and carcinoma) and non-neoplastic (most commonly hyperplastic). Standard endoscopic inspection cannot reliably distinguish between polyp types. Thus, all visualized polyps during standard colonoscopies are typically removed. Since almost half of all polyps are hyperplastic, a large proportion of unnecessary polypectomies increase the time, risk, and cost of colonoscopies.
Various studies have showed improved diagnostic accuracy of different types of polyps when broad field techniques such as chromoendoscopy with the use of topical stains were used to detect and characterize lesions (2-4). Chromoendoscopy, though an approved method of lesion characterization during endoscopic evaluation of colorectal lesions, is time consuming and non-standardized. Recently small field techniques such as confocal microscopy and endocytoscopy have been introduced enabling visualization of the gastrointestinal tract at a cellular level, thus allowing diagnosis and classification of colorectal lesions in vivo.
Confocal endomicroscopy used along with chromoendoscopy to detect and characterize lesions has been studied extensively and reported to have a high accuracy in diagnosing neoplastic and nonneoplastic lesions of the gastrointestinal tract (5-12). One of the major limitations of the confocal system is the mandatory use of dyes such as topical Acriflavine or intravenous Fluorescein. However, there are issues with the application of these dyes; the risk of DNA damage with Acriflavine reduced its use. In addition, although intravenous fluorescein is FDA approved for diagnostic fluorescein angiography, its gastrointestinal application is an off-label indication and considered class IIb by the FDA. The other major limitation of the current confocal system is that it requires a dedicated confocal endoscope marketed by a single manufacturer. Thus, the use of confocal imaging requires purchase of specific confocal endoscopes.
Endocytoscopy is based on the technology of light-contact microscopy. The current endocytoscopy system (ECS) consists of two prototypes; Prototype one gives a low magnification (XEC300) with a maximal 450X magnification and field of view of 300X300 um, Prototype two provide a high magnification (XEC120) with a maximal 1100X magnification and a field of view of 120X120 um. In contrast to confocal endomicroscopy, the endocytoscopes can be easily passed through an accessory channel of the conventional therapeutic endoscope. This method does not require the use of intravenous contrast agents. Instead, it uses topical staining such as methylene blue or crestyl violet, which is applied routinely to facilitate visualization and removal of advanced colorectal polyps through endoscopic mucosal resection during colonoscopy.
The endocytoscopy system has only recently been introduced and hence there are very few studies reporting its use.
A prospective study from Japan used endocytoscopy on 113 patients to obtain real time histological images in vivo during colonoscopy (13). With the ECS system, it was possible to observe lesions at the cellular level, evaluate cellular atypia and distinguish between neoplastic and nonneoplastic lesions when compared to histology which was used as the gold standard. The correlation between the endocytoscopic and histological diagnosis was statistically significant. Eleber et al (14) also reported a sensitivity and specificity of 79% and 90 %, respectively of the ECS system in diagnosing neoplastic lesions in 28 patients with colonic lesions. Furthermore the study by Cipoletta et al (15) demonstrated that the ECS system provides real time imaging in vivo with clear visualization of cellular details and features of dysplasia of aberrant crypt foci, considered to be the earliest precursor of colorectal cancer. In addition Rotondano et al (15) also confirmed high positive predictive values for diagnosing hyperplastic polyps as well as dysplastic polyps including low, high grade dysplasia as well as invasive cancer.
A recent systematic review of all published studies also confirmed that endocytoscopy is a safe and effective new endoscopic imaging technique to obtain in vivo histology and guided biopsies with high diagnostic accuracy (17).
No associated risks related to the endocystoscopy procedures have been reported in all published studies (12-17).
This specific diagnostic tool of in vivo histology with the use of high resolution endocytoscopy system would allow endoscopists to perform targeted biopsies and in some cases (if warranted based on the in vivo images) to proceed directly to endoscopic resection of lesions. It may also guide assessment of the completeness of the endoscopic intervention with detection of any residual neoplastic tissue at the index exam as well as on follow up colonoscopy exams. Other potential benefits include elimination of random biopsies for surveillance of mucosal disease, elimination of sampling error, limitation of unnecessary polypectomies, hence ultimately resulting in cost effectiveness and improved patient outcomes.
In summary, endocytoscopy has the potential to fundamentally change the way endoscopy and pathology interact by allowing near histological quality imaging in vivo, without the need, risk, and cost of tissue removal.
- Conditions
- Colon Cancer
- Being tested
- Endocystoscopy During Colonoscopy, Endocytoscope
- Keywords
- colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocystoscopy During ColonoscopyDevice
Also called endocytoscope
Colonoscopies will be performed as per routine practice. When a colorectal lesion is found that would normally require biopsy or polypectomy; the lesion will be evaluated by chromoendoscopy with the application of 10 ml 1% methylene blue followed by the inspection with the endocytoscope at both magnifications (450X and 1100X). The endocytoscopic images of the abnormal area will be recorded prior to biopsy or removal of the suspicious tissue. For each lesion, a matching endocytoscopy image from normal adjacent tissue will also be obtained, at least 5cm away from the suspect site, but within the same segment of intestine (e.g. ascending colon). No biopsy will be obtained from normal tissue, and this will be assumed to be normal. Following image acquisition, the lesion will be biopsied or removed as per standard clinical care.
EndocytoscopeDevice
The endocytoscopes, prototype I and prototype II will be used during the study along with the standard colonoscopes. The endocytoscope is a soft catheter type endoscope, with an outside diameter of 3.4 mm at the distal end and 3.2 at the shaft, and total length of 380 cm (working length of 250 cm) which uses a lens system for magnification. The Prototype 1 endocytoscope (low resolution type) has a magnification capability of x 450, depth of field of 50 um, field of view of 300X 300 um with a spatial resolution of 1.7 um. The Prototype 2 (high resolution) has a magnification capability of x1125, depth of field of 5um, field of view of 120X 120 um, and a spatial resolution of 4.2 um, The ECS system can be passed through the working channel of a standard colonoscope.
| Study group | Role | What they receive |
|---|---|---|
| Endocytoscopy During Colonoscopy | Experimental | Colonoscopies will be performed as per routine practice. When a colorectal lesion is found that would normally require biopsy or polypectomy; the lesion will be evaluated by chromoendoscopy with the application of 10 ml 1% methylene blue followed by the inspection with the endocytoscope at both magnifications (450X and 1100X). The endocytoscopic images of the abnormal area will be recorded prior to biopsy or removal of the suspicious tissue. For each lesion, a matching endocytoscopy image from normal adjacent tissue will also be obtained, at least 5cm away from the suspect site, but within the same segment of intestine (e.g. ascending colon). No biopsy will be obtained from normal tissue, and this will be assumed to be normal. Following image acquisition, the lesion will be biopsied or removed as per standard clinical care. Receives: Device: Endocystoscopy During Colonoscopy; Device: Endocytoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unblinded Analysis of Endocytoscopic Images of Colorectal Lesions (Technical quality of the images will be compared to histology and rated on a scale of 1-5 (1-worst, 3- acceptable, 5-being equal to histology)
Endocytoscopic images of colorectal lesions will be reviewed in an unblinded fashion, in a group of 10 side by side images, by the endoscopists (AMB, NA) and the pathologist (AS). Technical quality of the images will be compared to histology and rated on a scale of 1-5 (1-worst, 3- acceptable, 5-being equal to histology). Only images with a score of 3 or better will be used for analysis. The percentage of cases with at least one adequate image per site will be described. The basic characteristics of images allowing distinction between neoplastic, non-neoplastic and normal tissue will be established.
Measured: 30 Days (from Colonoscopy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJun 2011
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324374
- Sponsor's protocol ID
- 813061
- Status last verified
- Jan 2023
- First submitted
- 18 Dec 2014
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Publications
Hawk ET, Levin B. Colorectal cancer prevention. J Clin Oncol. 2005 Jan 10;23(2):378-91. doi: 10.1200/JCO.2005.08.097.
PubMed 15637400Hurlstone DP, Fujii T, Lobo AJ. Early detection of colorectal cancer using high-magnification chromoscopic colonoscopy. Br J Surg. 2002 Mar;89(3):272-82. doi: 10.1046/j.0007-1323.2001.02040.x.
PubMed 11872049Hurlstone DP, Cross SS, Slater R, Sanders DS, Brown S. Detecting diminutive colorectal lesions at colonoscopy: a randomised controlled trial of pan-colonic versus targeted chromoscopy. Gut. 2004 Mar;53(3):376-80. doi: 10.1136/gut.2003.029868.
PubMed 14960519Kiesslich R, Fritsch J, Holtmann M, Koehler HH, Stolte M, Kanzler S, Nafe B, Jung M, Galle PR, Neurath MF. Methylene blue-aided chromoendoscopy for the detection of intraepithelial neoplasia and colon cancer in ulcerative colitis. Gastroenterology. 2003 Apr;124(4):880-8. doi: 10.1053/gast.2003.50146.
PubMed 12671882Kiesslich R, Burg J, Vieth M, Gnaendiger J, Enders M, Delaney P, Polglase A, McLaren W, Janell D, Thomas S, Nafe B, Galle PR, Neurath MF. Confocal laser endoscopy for diagnosing intraepithelial neoplasias and colorectal cancer in vivo. Gastroenterology. 2004 Sep;127(3):706-13. doi: 10.1053/j.gastro.2004.06.050.
PubMed 15362025Sakashita M, Inoue H, Kashida H, Tanaka J, Cho JY, Satodate H, Hidaka E, Yoshida T, Fukami N, Tamegai Y, Shiokawa A, Kudo S. Virtual histology of colorectal lesions using laser-scanning confocal microscopy. Endoscopy. 2003 Dec;35(12):1033-8. doi: 10.1055/s-2003-44595.
PubMed 14648417Polglase AL, McLaren WJ, Skinner SA, Kiesslich R, Neurath MF, Delaney PM. A fluorescence confocal endomicroscope for in vivo microscopy of the upper- and the lower-GI tract. Gastrointest Endosc. 2005 Nov;62(5):686-95. doi: 10.1016/j.gie.2005.05.021.
PubMed 16246680Kiesslich R, Goetz M, Lammersdorf K, Schneider C, Burg J, Stolte M, Vieth M, Nafe B, Galle PR, Neurath MF. Chromoscopy-guided endomicroscopy increases the diagnostic yield of intraepithelial neoplasia in ulcerative colitis. Gastroenterology. 2007 Mar;132(3):874-82. doi: 10.1053/j.gastro.2007.01.048. Epub 2007 Jan 31.
PubMed 17383417Kiesslich R, Gossner L, Goetz M, Dahlmann A, Vieth M, Stolte M, Hoffman A, Jung M, Nafe B, Galle PR, Neurath MF. In vivo histology of Barrett's esophagus and associated neoplasia by confocal laser endomicroscopy. Clin Gastroenterol Hepatol. 2006 Aug;4(8):979-87. doi: 10.1016/j.cgh.2006.05.010. Epub 2006 Jul 13.
PubMed 16843068Kiesslich R, Hoffman A, Goetz M, Biesterfeld S, Vieth M, Galle PR, Neurath MF. In vivo diagnosis of collagenous colitis by confocal endomicroscopy. Gut. 2006 Apr;55(4):591-2. doi: 10.1136/gut.2005.084970. No abstract available.
PubMed 16531549Kiesslich R, Goetz M, Burg J, Stolte M, Siegel E, Maeurer MJ, Thomas S, Strand D, Galle PR, Neurath MF. Diagnosing Helicobacter pylori in vivo by confocal laser endoscopy. Gastroenterology. 2005 Jun;128(7):2119-23. doi: 10.1053/j.gastro.2004.12.035.
PubMed 15940642Sasajima K, Kudo SE, Inoue H, Takeuchi T, Kashida H, Hidaka E, Kawachi H, Sakashita M, Tanaka J, Shiokawa A. Real-time in vivo virtual histology of colorectal lesions when using the endocytoscopy system. Gastrointest Endosc. 2006 Jun;63(7):1010-7. doi: 10.1016/j.gie.2006.01.021.
PubMed 16733118Eberl T, Jechart G, Probst A, Golczyk M, Bittinger M, Scheubel R, Arnholdt H, Knuechel R, Messmann H. Can an endocytoscope system (ECS) predict histology in neoplastic lesions? Endoscopy. 2007 Jun;39(6):497-501. doi: 10.1055/s-2007-966446.
PubMed 17554643Cipolletta L, Bianco MA, Rotondano G, Piscopo R, Meucci C, Prisco A, Cipolletta F, de Gregorio A, Salvati A. Endocytoscopy can identify dysplasia in aberrant crypt foci of the colorectum: a prospective in vivo study. Endoscopy. 2009 Feb;41(2):129-32. doi: 10.1055/s-0028-1103452. Epub 2009 Feb 12.
PubMed 19214891Rotondano G, Bianco MA, Salerno R, Meucci C, Prisco A, Garofano ML, Sansone S, Cipolletta L. Endocytoscopic classification of preneoplastic lesions in the colorectum. Int J Colorectal Dis. 2010 Sep;25(9):1111-6. doi: 10.1007/s00384-010-0969-7. Epub 2010 Jun 8.
PubMed 20532533
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of in Vivo Real Time Endocytoscopy in Diagnosing Colorectal Neoplasia
- ClinicalTrials.gov ID
- NCT02324374
- Acronym / sponsor ID
- 813061
- Conditions
- Colon Cancer
- Keywords
- colon cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 24 Dec 2014 (estimated)
- 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.
This will be a feasibility study to evaluate the role of endocytoscopy in classifying colorectal polyps in vivo. The primary outcomes will be to determine the key endocytoscopy image features of neoplastic and non-neoplastic colorectal polyps. The target population will include adult subjects undergoing screening and surveillance colonoscopies.
Detailed description
Colorectal cancer has been recognized as the second most common cause of cancer related death in the US (1). Most colorectal cancers arise from adenomatous polyps that progress. Colon polyps are usually classified as neoplastic (adenoma and carcinoma) and non-neoplastic (most commonly hyperplastic). Standard endoscopic inspection cannot reliably distinguish between polyp types. Thus, all visualized polyps during standard colonoscopies are typically removed. Since almost half of all polyps are hyperplastic, a large proportion of unnecessary polypectomies increase the time, risk, and cost of colonoscopies.
Various studies have showed improved diagnostic accuracy of different types of polyps when broad field techniques such as chromoendoscopy with the use of topical stains were used to detect and characterize lesions (2-4). Chromoendoscopy, though an approved method of lesion characterization during endoscopic evaluation of colorectal lesions, is time consuming and non-standardized. Recently small field techniques such as confocal microscopy and endocytoscopy have been introduced enabling visualization of the gastrointestinal tract at a cellular level, thus allowing diagnosis and classification of colorectal lesions in vivo.
Confocal endomicroscopy used along with chromoendoscopy to detect and characterize lesions has been studied extensively and reported to have a high accuracy in diagnosing neoplastic and nonneoplastic lesions of the gastrointestinal tract (5-12). One of the major limitations of the confocal system is the mandatory use of dyes such as topical Acriflavine or intravenous Fluorescein. However, there are issues with the application of these dyes; the risk of DNA damage with Acriflavine reduced its use. In addition, although intravenous fluorescein is FDA approved for diagnostic fluorescein angiography, its gastrointestinal application is an off-label indication and considered class IIb by the FDA. The other major limitation of the current confocal system is that it requires a dedicated confocal endoscope marketed by a single manufacturer. Thus, the use of confocal imaging requires purchase of specific confocal endoscopes.
Endocytoscopy is based on the technology of light-contact microscopy. The current endocytoscopy system (ECS) consists of two prototypes; Prototype one gives a low magnification (XEC300) with a maximal 450X magnification and field of view of 300X300 um, Prototype two provide a high magnification (XEC120) with a maximal 1100X magnification and a field of view of 120X120 um. In contrast to confocal endomicroscopy, the endocytoscopes can be easily passed through an accessory channel of the conventional therapeutic endoscope. This method does not require the use of intravenous contrast agents. Instead, it uses topical staining such as methylene blue or crestyl violet, which is applied routinely to facilitate visualization and removal of advanced colorectal polyps through endoscopic mucosal resection during colonoscopy.
The endocytoscopy system has only recently been introduced and hence there are very few studies reporting its use.
A prospective study from Japan used endocytoscopy on 113 patients to obtain real time histological images in vivo during colonoscopy (13). With the ECS system, it was possible to observe lesions at the cellular level, evaluate cellular atypia and distinguish between neoplastic and nonneoplastic lesions when compared to histology which was used as the gold standard. The correlation between the endocytoscopic and histological diagnosis was statistically significant. Eleber et al (14) also reported a sensitivity and specificity of 79% and 90 %, respectively of the ECS system in diagnosing neoplastic lesions in 28 patients with colonic lesions. Furthermore the study by Cipoletta et al (15) demonstrated that the ECS system provides real time imaging in vivo with clear visualization of cellular details and features of dysplasia of aberrant crypt foci, considered to be the earliest precursor of colorectal cancer. In addition Rotondano et al (15) also confirmed high positive predictive values for diagnosing hyperplastic polyps as well as dysplastic polyps including low, high grade dysplasia as well as invasive cancer.
A recent systematic review of all published studies also confirmed that endocytoscopy is a safe and effective new endoscopic imaging technique to obtain in vivo histology and guided biopsies with high diagnostic accuracy (17).
No associated risks related to the endocystoscopy procedures have been reported in all published studies (12-17).
This specific diagnostic tool of in vivo histology with the use of high resolution endocytoscopy system would allow endoscopists to perform targeted biopsies and in some cases (if warranted based on the in vivo images) to proceed directly to endoscopic resection of lesions. It may also guide assessment of the completeness of the endoscopic intervention with detection of any residual neoplastic tissue at the index exam as well as on follow up colonoscopy exams. Other potential benefits include elimination of random biopsies for surveillance of mucosal disease, elimination of sampling error, limitation of unnecessary polypectomies, hence ultimately resulting in cost effectiveness and improved patient outcomes.
In summary, endocytoscopy has the potential to fundamentally change the way endoscopy and pathology interact by allowing near histological quality imaging in vivo, without the need, risk, and cost of tissue removal.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endocytoscopy During Colonoscopy | Experimental | Device: Endocystoscopy During Colonoscopy, Device: EndocytoscopeColonoscopies will be performed as per routine practice. When a colorectal lesion is found that would normally require biopsy or polypectomy; the lesion will be evaluated by chromoendoscopy with the application of 10 ml 1% methylene blue followed by the inspection with the endocytoscope at both magnifications (450X and 1100X). The endocytoscopic images of the abnormal area will be recorded prior to biopsy or removal of the suspicious tissue. For each lesion, a matching endocytoscopy image from normal adjacent tissue will also be obtained, at least 5cm away from the suspect site, but within the same segment of intestine (e.g. ascending colon). No biopsy will be obtained from normal tissue, and this will be assumed to be normal. Following image acquisition, the lesion will be biopsied or removed as per standard clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age above 18, any patient undergoing screening or surveillance colonoscopy.
Key exclusion criteria (3 listed)
- Pregnancy
- Unwillingness to consent
- Lack of any pathological state that would require biopsy at the time of endoscopy (will be considered "screen failure" since this will not be known until after consent is obtained and sedated endoscopy performed).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endocystoscopy During ColonoscopyAlso: endocytoscopeColonoscopies will be performed as per routine practice. When a colorectal lesion is found that would normally require biopsy or polypectomy; the lesion will be evaluated by chromoendoscopy with the application of 10 ml 1% methylene blue followed by the inspection with the endocytoscope at both magnifications (450X and 1100X). The endocytoscopic images of the abnormal area will be recorded prior to biopsy or removal of the suspicious tissue. For each lesion, a matching endocytoscopy image from normal adjacent tissue will also be obtained, at least 5cm away from the suspect site, but within the same segment of intestine (e.g. ascending colon). No biopsy will be obtained from normal tissue, and this will be assumed to be normal. Following image acquisition, the lesion will be biopsied or removed as per standard clinical care. | Device | Endocytoscopy During Colonoscopy |
| EndocytoscopeThe endocytoscopes, prototype I and prototype II will be used during the study along with the standard colonoscopes. The endocytoscope is a soft catheter type endoscope, with an outside diameter of 3.4 mm at the distal end and 3.2 at the shaft, and total length of 380 cm (working length of 250 cm) which uses a lens system for magnification. The Prototype 1 endocytoscope (low resolution type) has a magnification capability of x 450, depth of field of 50 um, field of view of 300X 300 um with a spatial resolution of 1.7 um. The Prototype 2 (high resolution) has a magnification capability of x1125, depth of field of 5um, field of view of 120X 120 um, and a spatial resolution of 4.2 um, The ECS system can be passed through the working channel of a standard colonoscope. | Device | Endocytoscopy During Colonoscopy |
Primary outcome
Unblinded Analysis of Endocytoscopic Images of Colorectal Lesions (Technical quality of the images will be compared to histology and rated on a scale of 1-5 (1-worst, 3- acceptable, 5-being equal to histology)
Time frame: 30 Days (from Colonoscopy)
Endocytoscopic images of colorectal lesions will be reviewed in an unblinded fashion, in a group of 10 side by side images, by the endoscopists (AMB, NA) and the pathologist (AS). Technical quality of the images will be compared to histology and rated on a scale of 1-5 (1-worst, 3- acceptable, 5-being equal to histology). Only images with a score of 3 or better will be used for analysis. The percentage of cases with at least one adequate image per site will be described. The basic characteristics of images allowing distinction between neoplastic, non-neoplastic and normal tissue will be established.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Background: PubMed 15637400Hawk ET, Levin B. Colorectal cancer prevention. J Clin Oncol. 2005 Jan 10;23(2):378-91. doi: 10.1200/JCO.2005.08.097.
- Background: PubMed 11872049Hurlstone DP, Fujii T, Lobo AJ. Early detection of colorectal cancer using high-magnification chromoscopic colonoscopy. Br J Surg. 2002 Mar;89(3):272-82. doi: 10.1046/j.0007-1323.2001.02040.x.
- Background: PubMed 14960519Hurlstone DP, Cross SS, Slater R, Sanders DS, Brown S. Detecting diminutive colorectal lesions at colonoscopy: a randomised controlled trial of pan-colonic versus targeted chromoscopy. Gut. 2004 Mar;53(3):376-80. doi: 10.1136/gut.2003.029868.
- Background: PubMed 12671882Kiesslich R, Fritsch J, Holtmann M, Koehler HH, Stolte M, Kanzler S, Nafe B, Jung M, Galle PR, Neurath MF. Methylene blue-aided chromoendoscopy for the detection of intraepithelial neoplasia and colon cancer in ulcerative colitis. Gastroenterology. 2003 Apr;124(4):880-8. doi: 10.1053/gast.2003.50146.
- Background: PubMed 15362025Kiesslich R, Burg J, Vieth M, Gnaendiger J, Enders M, Delaney P, Polglase A, McLaren W, Janell D, Thomas S, Nafe B, Galle PR, Neurath MF. Confocal laser endoscopy for diagnosing intraepithelial neoplasias and colorectal cancer in vivo. Gastroenterology. 2004 Sep;127(3):706-13. doi: 10.1053/j.gastro.2004.06.050.
- Background: PubMed 14648417Sakashita M, Inoue H, Kashida H, Tanaka J, Cho JY, Satodate H, Hidaka E, Yoshida T, Fukami N, Tamegai Y, Shiokawa A, Kudo S. Virtual histology of colorectal lesions using laser-scanning confocal microscopy. Endoscopy. 2003 Dec;35(12):1033-8. doi: 10.1055/s-2003-44595.
- Background: PubMed 16246680Polglase AL, McLaren WJ, Skinner SA, Kiesslich R, Neurath MF, Delaney PM. A fluorescence confocal endomicroscope for in vivo microscopy of the upper- and the lower-GI tract. Gastrointest Endosc. 2005 Nov;62(5):686-95. doi: 10.1016/j.gie.2005.05.021.
- Background: PubMed 17383417Kiesslich R, Goetz M, Lammersdorf K, Schneider C, Burg J, Stolte M, Vieth M, Nafe B, Galle PR, Neurath MF. Chromoscopy-guided endomicroscopy increases the diagnostic yield of intraepithelial neoplasia in ulcerative colitis. Gastroenterology. 2007 Mar;132(3):874-82. doi: 10.1053/j.gastro.2007.01.048. Epub 2007 Jan 31.
- Background: PubMed 16843068Kiesslich R, Gossner L, Goetz M, Dahlmann A, Vieth M, Stolte M, Hoffman A, Jung M, Nafe B, Galle PR, Neurath MF. In vivo histology of Barrett's esophagus and associated neoplasia by confocal laser endomicroscopy. Clin Gastroenterol Hepatol. 2006 Aug;4(8):979-87. doi: 10.1016/j.cgh.2006.05.010. Epub 2006 Jul 13.
- Background: PubMed 16531549Kiesslich R, Hoffman A, Goetz M, Biesterfeld S, Vieth M, Galle PR, Neurath MF. In vivo diagnosis of collagenous colitis by confocal endomicroscopy. Gut. 2006 Apr;55(4):591-2. doi: 10.1136/gut.2005.084970. No abstract available.
- Background: PubMed 15940642Kiesslich R, Goetz M, Burg J, Stolte M, Siegel E, Maeurer MJ, Thomas S, Strand D, Galle PR, Neurath MF. Diagnosing Helicobacter pylori in vivo by confocal laser endoscopy. Gastroenterology. 2005 Jun;128(7):2119-23. doi: 10.1053/j.gastro.2004.12.035.
- Background: PubMed 16733118Sasajima K, Kudo SE, Inoue H, Takeuchi T, Kashida H, Hidaka E, Kawachi H, Sakashita M, Tanaka J, Shiokawa A. Real-time in vivo virtual histology of colorectal lesions when using the endocytoscopy system. Gastrointest Endosc. 2006 Jun;63(7):1010-7. doi: 10.1016/j.gie.2006.01.021.
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Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocystoscopy During Colonoscopy and Endocytoscope in people with Colon Cancer, run by University of Pennsylvania at 1 site in United States.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 25 Jan 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Unblinded Analysis of Endocytoscopic Images of Colorectal Lesions (Technical quality of the images will be compared to histology and rated on a scale of 1-5 (1-worst, 3- acceptable, 5-being equal to histology) (time frame: 30 Days (from Colonoscopy)). 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 NCT02324374, which also lists 16 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 25 Jan 2023.