Novel Endoscopic Imaging Methods for the Evaluation of Blood Vessels in Gastrointestinal Cancers

NCT02672774 | Unknown DMC

• 1 other identifier: PN-II-RU-TE-2014-4-2289
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Gastric Cancer; Colorectal Cancer; Gastrointestinal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  15 months

Secondary Outcomes (1)

• Validation of endoscopic imaging findings from immunohistochemical analysis with MVD calculations

  24 months

Study Arms (2)

Gastric cancer

OTHER

Consecutive patients with gastric cancer will be examined using magnification endoscopy with narrow band imaging and probe based confocal laser endomicroscopy.

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.

Procedure: Magnification endoscopy with narrow band imaging; Device: Probe based confocal laser endomicroscopy

Interventions

Magnification endoscopy with narrow band imaging PROCEDURE

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.

Also known as: M-NBI

Colorectal cancer; Gastric cancer

Probe based confocal laser endomicroscopy DEVICE

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.

Also known as: pCLE

Colorectal cancer; Gastric cancer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Failure to provide informed consent
• Prior or ongoing chemo- and/or radiotherapy
• Patients with a contraindication for GI endoscopic procedures
• Known allergy to fluorescein

Sponsors & Collaborators

• University of Medicine and Pharmacy Craiova: lead

Study Sites (1)

Research Center of Gastroenterology and Hepatology, University of Medicine and Pharmacy

Craiova, 200349, Romania

RECRUITING

Related Publications (7)

• 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.

  PMID: 15563306 BACKGROUND

• Aihara 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.

  PMID: 23053681 BACKGROUND

• Hirata 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.

  PMID: 22269282 BACKGROUND

• Gheonea 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.

  PMID: 21218080 BACKGROUND

• Sanduleanu 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.

  PMID: 19683597 BACKGROUND

• Bok 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.

  PMID: 23473002 BACKGROUND

• Wang 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.

  PMID: 23002348 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms; Colorectal Neoplasms; Gastrointestinal Neoplasms

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Dan I. Gheonea, Assoc. Prof.

  University of Medicine and Pharmacy Craiova

  STUDY DIRECTOR

Central Study Contacts

Dan I. Gheonea, Assoc. Prof.

CONTACT

+4 0751 268731; digheonea@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 3, 2016
• Study Start: October 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 3, 2016

Record last verified: 2016-01

Locations

RO (1)