Gastric CancerIM-ANGNCT02672774
Novel Endoscopic Imaging Methods for the Evaluation of Blood Vessels in Gastrointestinal Cancers
A study testing Magnification endoscopy with narrow band imaging and Probe based confocal laser endomicroscopy in people with Gastric Cancer and Colorectal Cancer, run by University of Medicine and Pharmacy Craiova at 1 site in Romania.
Trial summary
The aim of the project is to study the role of minimally invasive imaging methods, such as magnification endoscopy with narrow-band imaging (M-NBI) combined with confocal laser endomicroscopy (CLE), in correlation with immunohistochemical analysis, for assessing the angiogenesis status of patients with… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastric Cancer, Colorectal Cancer, Gastrointestinal Neoplasms
- What is being tested?
- Magnification endoscopy with narrow band imaging and Probe based confocal laser endomicroscopy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRomania
- Study dates
- Oct 2015to Sep 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with gastric and colorectal cancer
- Age 18 to 90 years old, men or women
- Signed informed consent for M-NBI and pCLE examinations with tissue sampling.
Who cannot join
- Failure to provide informed consent
- Prior or ongoing chemo- and/or radiotherapy
- Patients with a contraindication for GI endoscopic procedures
- Known allergy to fluorescein
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Research Center of Gastroenterology and Hepatology, University of Medicine and Pharmacy
Craiova, 200349
Dan I. Gheonea, Assoc. Prof., +40751268731, digheonea@gmail.com
Tatiana Cârțână, MD, PhD, +40728070292, tatiana.cartana@gmail.com
About this study
Official title: Study of Minimally Invasive Endoscopic IMaging Methods for the Evaluation of neoANGiogenesis in Gastrointestinal Cancers
The aim of the project is to study the role of minimally invasive imaging methods, such as magnification endoscopy with narrow-band imaging (M-NBI) combined with confocal laser endomicroscopy (CLE), in correlation with immunohistochemical analysis, for assessing the angiogenesis status of patients with gastrointestinal tumors, in particular with colorectal and gastric cancer. Angiogenesis, i.e. the process of forming new blood vessels, represents an essential event for tumor growth and metastasis and the importance of its understanding stems from potential applications for diagnosis, prognosis stratification and mainly from the possibility of developing and improving targeted therapies. While current methods for evaluating tumor vascularity are based on immunohistochemistry techniques with microvascular density (MVD) calculations, these imply repeated tissue sampling and are not feasible in the context of clinical practice. Imaging techniques might overcome limitations associated with MDV measuring, obtaining both functional and morphological information and enabling repeated evaluations that are necessary for the assessment of a dynamic process as angiogenesis during follow-up of targeted therapies.
NBI is a digitally enhanced endoscopic imaging technique that uses optical filters to illuminate tissue with light at blue and green wavelengths. These are selectively absorbed by hemoglobin and, as a result superficial vascular networks are highlighted and morphological changes in capillary patterns can be described for different lesions. CLE represents a revolutionary technology that enables endoscopists to collect real-time in vivo histological images or "virtual biopsies" of the gastrointestinal mucosa during endoscopy, and has raised significant interest for the potential clinical applications and numerous research possibilities. After intravenous administration of fluorescein as a contrast agent, CLE enables real-time visualization of the tumor vasculature, which is structurally and functionally altered compared to the normal vascular networks. Therefore M-NBI will be used for enhanced visualization of morphological changes of the superficial capillaries, while CLE will be directed towards vascular regions of interest for characterization of these changes at the microscopic level. Furthermore, imaging studies will be backed by MVD calculation using immunohistochemical methods, based on tissue samples harvested during endoscopic procedures.
Read the detailed description
The key objectives of the project are:
- Real-time imaging of angiogenesis in GI tumors by using minimally invasive methods:
- Endoscopic magnification with narrow-band imaging (M-NBI) for macroscopic assessment of the vascular pattern
- In vivo probe-based confocal laser endomicroscopy (pCLE) for characterization of the microvascular pattern
- Offline analysis of M-NBI and pCLE sequences with additional image processing software
- Immunohistochemical evaluation of angiogenesis in GI cancers based on MVD calculation
- Comparing imaging (M-NBI and pCLE) and pathological (immunohistochemistry) data using computer aided diagnosis (CAD) The study will include patients with gastric (n=20) and colorectal (n=30) cancers that will be prospectively evaluated according to the predefined protocols.
Magnification endoscopy with narrow band imaging (M-NBI) will be performed for each patient after the identification of the lesion with conventional white light endoscopy. With only a push of a button optical filters are applied to reduce the illuminating light to 415 nm (blue) and 540 nm (green) wavelengths for enhanced visualization of capillary changes. Classification of the vascular pattern will be made on-site by the examiner (DIR) and multiple images will be saved for off-site later analysis. While interpretation of endoscopic images can be subjective and operator-dependent we will also perform an objective evaluation with computer-aided analysis based on image processing software. A vascular region of interest will be selected in NBI mode for targeted microscopic examination with pCLE and tissue sampling for pathology and IHC assessment. M-NBI examination will also be performed for normal mucosa for comparative analysis of the vascular pattern.
Confocal laser endomicroscopy (CLE) will be performed for visualization and characterization of vascular changes inside the tumor, using the probe-based CLE system (pCLE). The faster image acquisition rate of the pCLE system (12 frames per second) enables direct in vivo visualization of blood flow. The main advantage of the pCLE system is that it can be easily integrated into the imaging protocol as its flexible catheter probes can be passed through the working channels of the endoscopes once the vascular area of interest is selected with M-NBI. For pCLE examinations we will use fluorescein as a contrast agent which is already approved for in vivo human examinations. Fluorescein is administered intravenously, highlighting the vessels and surrounding epithelial structures. The vascular pattern will be assessed in real-time as well as off-site based on objective measurements of the stored sequences that will include different vascular parameters (vessel diameter, vascular density). These will be determined for both tumor tissue and normal adjacent mucosa as control, using dedicated software.
Immunohistochemistry (IHC) analysis with MVD calculations will be assessed and correlated to the imaging findings. Paired biopsies of tumors and normal GI mucosa obtained during endoscopic procedures (ensuring co-registration with M-NBI and pCLE examined regions) will be processed for fixation in 10% neutral buffered formalin (NBF), paraffin embedding and sectioning. For MVD analysis, the blocks will be completely cut in serial sections 4-25 μm-thick, with one thick section for every 10 thin sections. In order to assess the total vascular architecture we will utilize non-selective endothelial cell markers, such as anti-CD31 and anti-CD34 antibodies.
- Being tested
- Magnification endoscopy with narrow band imaging, Probe based confocal laser endomicroscopy
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnification endoscopy with narrow band imagingProcedure or surgery
Also called M-NBI
Magnification endoscopy with narrow band imaging is an optically enhanced endoscopic imaging technique used for better characterization of lesions as compared to white light endoscopy alone. With only a push of a button optical filters are applied to reduce the illuminating light to 415 nm (blue) and 540 nm (green) wavelengths, which are selectively absorbed by haemoglobin. As a result the superficial vascular networks are highlighted and morphological changes in capillary patterns can be described for different gastrointestinal lesions.
Probe based confocal laser endomicroscopyDevice
Also called pCLE
Confocal laser endomicroscopy enables in vivo microscopic analysis during ongoing endoscopy and has shown good accuracy for predicting the histopathological diagnosis in lesions of both the upper and lower GI tract. During the examination fluorescein is administered intravenously as a contrast agent, highlighting the vessels and surrounding epithelial structures. The probe based confocal laser endomicroscopy system can be easily integrated into the imaging protocol as it uses flexible catheter probes that can be passed through the working channels of the endoscopes once the area of interest has been identified.
| Study group | Role | What they receive |
|---|---|---|
| Gastric cancer | Other | Consecutive patients with gastric cancer will be examined using magnification endoscopy with narrow band imaging and probe based confocal laser endomicroscopy. Receives: Procedure: Magnification endoscopy with narrow band imaging; Device: Probe based confocal laser endomicroscopy |
| Colorectal cancer | Other | Consecutive patients with colorectal cancer will be examined using magnification endoscopy with narrow band imaging and probe based confocal laser endomicroscopy. Receives: Procedure: Magnification endoscopy with narrow band imaging; Device: Probe based confocal laser endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-time imaging of angiogenesis in gastric and colorectal tumors by using M-NBI and pCLE examinations
After identification of the lesion with conventional white light endoscopy, endoscopic magnification with narrow-band imaging (M-NBI) will be performed for enhanced visualization of the capillary changes. A vascular region of interest will be selected in the M-NBI mode for targeted microscopic examination with probe based confocal laser endomicroscopy (pCLE) and tissue sampling for pathology and immunohistochemistry assessment. The vascular pattern will be assessed in real-time by the examiner as well as off-site based on objective measurements of the stored sequences that will include different vascular parameters (vessel diameter, vascular density). These will be determined for both tumors and normal adjacent mucosa as control, using dedicated image processing software.
Measured: 15 months
Secondary outcomes (1)
Validation of endoscopic imaging findings from immunohistochemical analysis with MVD calculations
Paired biopsies of GI tumors and normal mucosa obtained during endoscopic procedures (ensuring co-registration with M-NBI and pCLE examined areas) will be processed for immunohistochemical analysis by utilizing anti-CD31 and anti-CD34 antibodies as endothelial cell markers. Microvascular density (MVD) calculations will be performed by using the 'hot-spot' method and the results will be compared to the vascular parameters as assessed from M-NBI and pCLE stored images.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startOct 2015
- Primary completionFeb 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy Craiova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan I. Gheonea, Assoc. Prof., Study director, University of Medicine and Pharmacy Craiova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672774
- Sponsor's protocol ID
- PN-II-RU-TE-2014-4-2289
- Acronym
- IM-ANG
- Status last verified
- Jan 2016
- First submitted
- 25 Jan 2016
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Fox SB, Harris AL. Histological quantitation of tumour angiogenesis. APMIS. 2004 Jul-Aug;112(7-8):413-30. doi: 10.1111/j.1600-0463.2004.apm11207-0803.x.
PubMed 15563306Aihara H, Saito S, Tajiri H. Rationale for and clinical benefits of colonoscopy with narrow band imaging: pathological prediction and colorectal screening. Int J Colorectal Dis. 2013 Jan;28(1):1-7. doi: 10.1007/s00384-012-1591-7. Epub 2012 Oct 9.
PubMed 23053681Hirata I, Nakagawa Y, Ohkubo M, Yahagi N, Yao K. Usefulness of magnifying narrow-band imaging endoscopy for the diagnosis of gastric and colorectal lesions. Digestion. 2012;85(2):74-9. doi: 10.1159/000334642. Epub 2012 Jan 19.
PubMed 22269282Gheonea DI, Cartana T, Ciurea T, Popescu C, Badarau A, Saftoiu A. Confocal laser endomicroscopy and immunoendoscopy for real-time assessment of vascularization in gastrointestinal malignancies. World J Gastroenterol. 2011 Jan 7;17(1):21-7. doi: 10.3748/wjg.v17.i1.21.
PubMed 21218080Sanduleanu S, Driessen A, Gomez-Garcia E, Hameeteman W, de Bruine A, Masclee A. In vivo diagnosis and classification of colorectal neoplasia by chromoendoscopy-guided confocal laser endomicroscopy. Clin Gastroenterol Hepatol. 2010 Apr;8(4):371-8. doi: 10.1016/j.cgh.2009.08.006. Epub 2009 Aug 13.
PubMed 19683597Bok GH, Jeon SR, Cho JY, Cho JH, Lee WC, Jin SY, Choi IH, Kim HG, Lee TH, Park EJ. The accuracy of probe-based confocal endomicroscopy versus conventional endoscopic biopsies for the diagnosis of superficial gastric neoplasia (with videos). Gastrointest Endosc. 2013 Jun;77(6):899-908. doi: 10.1016/j.gie.2013.01.018. Epub 2013 Mar 6.
PubMed 23473002Wang SF, Yang YS, Wei LX, Lu ZS, Guo MZ, Huang J, Peng LH, Sun G, Ling-Hu EQ, Meng JY. Diagnosis of gastric intraepithelial neoplasia by narrow-band imaging and confocal laser endomicroscopy. World J Gastroenterol. 2012 Sep 14;18(34):4771-80. doi: 10.3748/wjg.v18.i34.4771.
PubMed 23002348
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Minimally Invasive Endoscopic IMaging Methods for the Evaluation of neoANGiogenesis in Gastrointestinal Cancers
- ClinicalTrials.gov ID
- NCT02672774
- Acronym / sponsor ID
- IM-ANG / PN-II-RU-TE-2014-4-2289
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy CraiovaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 3 Feb 2016 (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.
The aim of the project is to study the role of minimally invasive imaging methods, such as magnification endoscopy with narrow-band imaging (M-NBI) combined with confocal laser endomicroscopy (CLE), in correlation with immunohistochemical analysis, for assessing the angiogenesis status of patients with gastrointestinal tumors, in particular with colorectal and gastric cancer. Angiogenesis, i.e. the process of forming new blood vessels, represents an essential event for tumor growth and metastasis and the importance of its understanding stems from potential applications for diagnosis, prognosis stratification and mainly from the possibility of developing and improving targeted therapies. While current methods for evaluating tumor vascularity are based on immunohistochemistry techniques with microvascular density (MVD) calculations, these imply repeated tissue sampling and are not feasible in the context of clinical practice. Imaging techniques might overcome limitations associated with MDV measuring, obtaining both functional and morphological information and enabling repeated evaluations that are necessary for the assessment of a dynamic process as angiogenesis during follow-up of targeted therapies.
NBI is a digitally enhanced endoscopic imaging technique that uses optical filters to illuminate tissue with light at blue and green wavelengths. These are selectively absorbed by hemoglobin and, as a result superficial vascular networks are highlighted and morphological changes in capillary patterns can be described for different lesions. CLE represents a revolutionary technology that enables endoscopists to collect real-time in vivo histological images or "virtual biopsies" of the gastrointestinal mucosa during endoscopy, and has raised significant interest for the potential clinical applications and numerous research possibilities. After intravenous administration of fluorescein as a contrast agent, CLE enables real-time visualization of the tumor vasculature, which is structurally and functionally altered compared to the normal vascular networks. Therefore M-NBI will be used for enhanced visualization of morphological changes of the superficial capillaries, while CLE will be directed towards vascular regions of interest for characterization of these changes at the microscopic level. Furthermore, imaging studies will be backed by MVD calculation using immunohistochemical methods, based on tissue samples harvested during endoscopic procedures.
Detailed description
The key objectives of the project are:
- Real-time imaging of angiogenesis in GI tumors by using minimally invasive methods:
- Endoscopic magnification with narrow-band imaging (M-NBI) for macroscopic assessment of the vascular pattern
- In vivo probe-based confocal laser endomicroscopy (pCLE) for characterization of the microvascular pattern
- Offline analysis of M-NBI and pCLE sequences with additional image processing software
- Immunohistochemical evaluation of angiogenesis in GI cancers based on MVD calculation
- Comparing imaging (M-NBI and pCLE) and pathological (immunohistochemistry) data using computer aided diagnosis (CAD) The study will include patients with gastric (n=20) and colorectal (n=30) cancers that will be prospectively evaluated according to the predefined protocols.
Magnification endoscopy with narrow band imaging (M-NBI) will be performed for each patient after the identification of the lesion with conventional white light endoscopy. With only a push of a button optical filters are applied to reduce the illuminating light to 415 nm (blue) and 540 nm (green) wavelengths for enhanced visualization of capillary changes. Classification of the vascular pattern will be made on-site by the examiner (DIR) and multiple images will be saved for off-site later analysis. While interpretation of endoscopic images can be subjective and operator-dependent we will also perform an objective evaluation with computer-aided analysis based on image processing software. A vascular region of interest will be selected in NBI mode for targeted microscopic examination with pCLE and tissue sampling for pathology and IHC assessment. M-NBI examination will also be performed for normal mucosa for comparative analysis of the vascular pattern.
Confocal laser endomicroscopy (CLE) will be performed for visualization and characterization of vascular changes inside the tumor, using the probe-based CLE system (pCLE). The faster image acquisition rate of the pCLE system (12 frames per second) enables direct in vivo visualization of blood flow. The main advantage of the pCLE system is that it can be easily integrated into the imaging protocol as its flexible catheter probes can be passed through the working channels of the endoscopes once the vascular area of interest is selected with M-NBI. For pCLE examinations we will use fluorescein as a contrast agent which is already approved for in vivo human examinations. Fluorescein is administered intravenously, highlighting the vessels and surrounding epithelial structures. The vascular pattern will be assessed in real-time as well as off-site based on objective measurements of the stored sequences that will include different vascular parameters (vessel diameter, vascular density). These will be determined for both tumor tissue and normal adjacent mucosa as control, using dedicated software.
Immunohistochemistry (IHC) analysis with MVD calculations will be assessed and correlated to the imaging findings. Paired biopsies of tumors and normal GI mucosa obtained during endoscopic procedures (ensuring co-registration with M-NBI and pCLE examined regions) will be processed for fixation in 10% neutral buffered formalin (NBF), paraffin embedding and sectioning. For MVD analysis, the blocks will be completely cut in serial sections 4-25 μm-thick, with one thick section for every 10 thin sections. In order to assess the total vascular architecture we will utilize non-selective endothelial cell markers, such as anti-CD31 and anti-CD34 antibodies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer | Other | Procedure: Magnification endoscopy with narrow band imaging, Device: Probe based confocal laser endomicroscopyConsecutive patients with gastric cancer will be examined using magnification endoscopy with narrow band imaging and probe based confocal laser endomicroscopy. |
| Colorectal cancer | Other | Procedure: Magnification endoscopy with narrow band imaging, Device: Probe based confocal laser endomicroscopyConsecutive patients with colorectal cancer will be examined using magnification endoscopy with narrow band imaging and probe based confocal laser endomicroscopy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with gastric and colorectal cancer
- Age 18 to 90 years old, men or women
- Signed informed consent for M-NBI and pCLE examinations with tissue sampling.
Key exclusion criteria (4 listed)
- Failure to provide informed consent
- Prior or ongoing chemo- and/or radiotherapy
- Patients with a contraindication for GI endoscopic procedures
- Known allergy to fluorescein
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 |
|---|---|---|
| Magnification endoscopy with narrow band imagingAlso: M-NBIMagnification endoscopy with narrow band imaging is an optically enhanced endoscopic imaging technique used for better characterization of lesions as compared to white light endoscopy alone. With only a push of a button optical filters are applied to reduce the illuminating light to 415 nm (blue) and 540 nm (green) wavelengths, which are selectively absorbed by haemoglobin. As a result the superficial vascular networks are highlighted and morphological changes in capillary patterns can be described for different gastrointestinal lesions. | Procedure or surgery | Colorectal cancer, Gastric cancer |
| Probe based confocal laser endomicroscopyAlso: pCLEConfocal laser endomicroscopy enables in vivo microscopic analysis during ongoing endoscopy and has shown good accuracy for predicting the histopathological diagnosis in lesions of both the upper and lower GI tract. During the examination fluorescein is administered intravenously as a contrast agent, highlighting the vessels and surrounding epithelial structures. The probe based confocal laser endomicroscopy system can be easily integrated into the imaging protocol as it uses flexible catheter probes that can be passed through the working channels of the endoscopes once the area of interest has been identified. | Device | Colorectal cancer, Gastric cancer |
Primary outcome
Real-time imaging of angiogenesis in gastric and colorectal tumors by using M-NBI and pCLE examinations
Time frame: 15 months
After identification of the lesion with conventional white light endoscopy, endoscopic magnification with narrow-band imaging (M-NBI) will be performed for enhanced visualization of the capillary changes. A vascular region of interest will be selected in the M-NBI mode for targeted microscopic examination with probe based confocal laser endomicroscopy (pCLE) and tissue sampling for pathology and immunohistochemistry assessment. The vascular pattern will be assessed in real-time by the examiner as well as off-site based on objective measurements of the stored sequences that will include different vascular parameters (vessel diameter, vascular density). These will be determined for both tumors and normal adjacent mucosa as control, using dedicated image processing software.
1 secondary outcome
Validation of endoscopic imaging findings from immunohistochemical analysis with MVD calculations
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Background: PubMed 15563306Fox SB, Harris AL. Histological quantitation of tumour angiogenesis. APMIS. 2004 Jul-Aug;112(7-8):413-30. doi: 10.1111/j.1600-0463.2004.apm11207-0803.x.
- Background: PubMed 23053681Aihara H, Saito S, Tajiri H. Rationale for and clinical benefits of colonoscopy with narrow band imaging: pathological prediction and colorectal screening. Int J Colorectal Dis. 2013 Jan;28(1):1-7. doi: 10.1007/s00384-012-1591-7. Epub 2012 Oct 9.
- Background: PubMed 22269282Hirata I, Nakagawa Y, Ohkubo M, Yahagi N, Yao K. Usefulness of magnifying narrow-band imaging endoscopy for the diagnosis of gastric and colorectal lesions. Digestion. 2012;85(2):74-9. doi: 10.1159/000334642. Epub 2012 Jan 19.
- Background: PubMed 21218080Gheonea DI, Cartana T, Ciurea T, Popescu C, Badarau A, Saftoiu A. Confocal laser endomicroscopy and immunoendoscopy for real-time assessment of vascularization in gastrointestinal malignancies. World J Gastroenterol. 2011 Jan 7;17(1):21-7. doi: 10.3748/wjg.v17.i1.21.
- Background: PubMed 19683597Sanduleanu S, Driessen A, Gomez-Garcia E, Hameeteman W, de Bruine A, Masclee A. In vivo diagnosis and classification of colorectal neoplasia by chromoendoscopy-guided confocal laser endomicroscopy. Clin Gastroenterol Hepatol. 2010 Apr;8(4):371-8. doi: 10.1016/j.cgh.2009.08.006. Epub 2009 Aug 13.
- Background: PubMed 23473002Bok GH, Jeon SR, Cho JY, Cho JH, Lee WC, Jin SY, Choi IH, Kim HG, Lee TH, Park EJ. The accuracy of probe-based confocal endomicroscopy versus conventional endoscopic biopsies for the diagnosis of superficial gastric neoplasia (with videos). Gastrointest Endosc. 2013 Jun;77(6):899-908. doi: 10.1016/j.gie.2013.01.018. Epub 2013 Mar 6.
- Background: PubMed 23002348Wang SF, Yang YS, Wei LX, Lu ZS, Guo MZ, Huang J, Peng LH, Sun G, Ling-Hu EQ, Meng JY. Diagnosis of gastric intraepithelial neoplasia by narrow-band imaging and confocal laser endomicroscopy. World J Gastroenterol. 2012 Sep 14;18(34):4771-80. doi: 10.3748/wjg.v18.i34.4771.
- 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.
Dan I. Gheonea, Assoc. Prof. study director
University of Medicine and Pharmacy Craiova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnification endoscopy with narrow band imaging and Probe based confocal laser endomicroscopy in people with Gastric Cancer and Colorectal Cancer, run by University of Medicine and Pharmacy Craiova at 1 site in Romania.
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 3 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: status not confirmed, as of the sponsor's last update on 3 Feb 2016. 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 Romania. 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?
Contact Dan I. Gheonea, Assoc. Prof. (+4 0751 268731, digheonea@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-time imaging of angiogenesis in gastric and colorectal tumors by using M-NBI and pCLE examinations (time frame: 15 months). 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 NCT02672774, which also lists 7 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 3 Feb 2016.