Neoplasms

Nervous System Diseases

All Conditions

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Endomicroscopic images are taken at several positions on the tumor.

Endomicroscope

Peter Nakaji, MD

The purpose of the study is to test the feasibility of obtaining interpretable in vivo endomicroscopy images which can be compared with traditional histopathology.

Hypothesis: That a rigid confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables differentiation of tumour tissue from normal adjacent brain tissue.

Confocal endomicroscopy is a medical imaging modality that allows real-time microscopy to be performed on living tissue in vivo. It is already in clinical use in the fields of gastroenterological endoscopy, laparoscopy, dermatology, gynecology and respiratory medicine. This study represents the first time that confocal endomicroscopy will be evaluated for intraoperative imaging in neurosurgery.

The procedure involves a small endoscope which is placed gently into contact with the brain, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. The captured confocal images will be compared with corresponding histology (tissue that is being removed as part of the indicated neurosurgical procedure). The images will be visually compared among each other and with histology images to detect possible clinically relevant information.

In Vivo Confocal Endomicroscopy of the Brain

Carl Zeiss Surgical GmbH

Dr. Gerhard Gaida / Clinical Affairs

Endomicroscopic images and biopsies are taken at several positions on the tumor.

Robert F Spetzler, MD

Kris Smith, MD

Jennifer Eschbacher, MD

This study aims to create an atlas based on the preliminary experience of the first feasibility study in neurosurgery. Hypothesis: That a confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables documentation of neurological pathology across a range of tumor ypes and grades, suitable for comparison with traditional histopathology from site-matched biopsies.

Confocal endomicroscopy is a medical imaging modality that allows real-time microscopy to be performed on living tissue in vivo. The procedure involves a small endoscope which is placed gently into contact with the tissue, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. It is already in clinical use in the field of gastroenterological endoscopy, and investigational use in laparoscopy, dermatology and gynecology. Further, in recent pilot studies endomicroscopy has also been shown to be feasible in bronchoscopy, robot assisted prostatectomy and neurosurgery.The study will use both endomicroscopy and biopsy to document the histological appearance of a range of neurological tumour types and grades.

In subsequent analysis, the confocal image data and corresponding histology data and images will be used to document reliably observable features in the confocal images that are relevant to histopathology interpretation. Relevant images will be selected and discussed by comparison to frozen or permanent section histology for compilation into an atlas documenting comparison for the tumors seen in the study.

In Vivo Confocal Microscopy Tumor Atlas Study

Digestive System Diseases

Symptoms and General Pathology

Colitis

Colitis, Ulcerative

Ulcer

Carcinoma

Carcinoma in Situ

Gastroenteritis

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Inflammatory Bowel Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Peter R. Galle, MD PhD

Timely diagnosis of intraepithelial neoplasias (premalignant condition)is of crucial importance for clinical management of ulcerative colitis. We assessed the value of combined chromoscopy and endomicroscopy for diagnosis of intraepithelial neoplasias in a randomised controlled trial.

Endomicroscopy is a new device which enables microscopy of the mucosal layer during ongoing colonoscopy. Chromoscopy means topical staining of mucosal surface to unmask areas of interest, which are subsequently examined with the endomicroscopic system.

Ulcerative colitis (UC) is an immune cell-mediated inflammatory bowel disease characterized by mucosal ulcerations, rectal bleeding, diarrhea, and abdominal pain. Patients with long standing UC face an increased risk for development of colitis associated colorectal cancer. Factors associated with increased risk for cancer development include the duration of the disease, extensive colonic involvement (pancolitis, backwash ileitis), primary sclerosing cholangitis and severe chronic active inflammation. Based on these observations, colonoscopic surveillance in patients with long-standing UC is highly recommended.

The main objective of surveillance colonoscopy in UC is to detect neoplasia at a surgically curative and preferably pre-invasive stage. However, in contrast to sporadic colorectal cancer, the growing pattern of neoplastic tissue in UC is often flat and multifocal. Therefore, significant lesions during conventional colonoscopy in UC are frequently overlooked. Chromoscopy with topically applied dyes such as methylene blue or indigo carmine facilitates the endoscopic detection of flat, circumscribed colitis associated neoplastic changes in UC. In fact, five controlled studies showed that the diagnostic yield for the detection of intraepithelial neoplasia (IN) using chromoscopy is higher as compared to conventional colonoscopy with random biopsies. Based on the above studies, chromoscopy has recently been considered for incorporation into US guidelines for surveillance of patients with long-standing UC. However, although this technique does allow identification of mucosal lesions, it is not suitable for accurate endoscopic diagnosis of intraepithelial neoplasias in UC due to the lack of cellular resolution and subsurface imaging. For endoscopy, novel techniques allowing accurate diagnoses during ongoing examination are highly desirable and may allow appropriate and immediate therapeutic manoeuvres (e.g. resection versus biopsy). Recently, a miniaturized confocal microscope has been developed integrated in the distal tip of a conventional colonoscope . This new diagnostic technology for gastrointestinal endoscopy, denoted confocal endomicroscopy, enables histological evaluation of the mucosal layer during ongoing colonoscopy. Furthermore, in patients screened for sporadic colorectal cancer, surface and subsurface analysis at cellular and subcellular resolution can be used to predict intraepithelial neoplasias (INs) with high accuracy. However, due to the time required for examination of large surface areas, this technique is not suitable for screening of the entire colonic surface in UC to detect neoplasias in flat mucosa.

In the present study, we employ chromoscopy to identify potential neoplastic lesions and combine this for the first time with endomicroscopy for the endoscopic diagnosis of colitis associated intraepithelial neoplasias in UC. Using such chromoscopy guided endomicroscopy we will ecaluate whether the diagnostic yield diagnosing IN can be significantly increased.

Chromoscopic Guided Endomicroscpy to Diagnose Colitis Associated Dysplasia

Diagnosis of Intraepithelial Neoplasia in Patients With Long Standing Ulcerative Colitis With Chromoscopic Guided Endomicroscopy

Johannes Gutenberg University Mainz

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
In Vivo Confocal Endomicroscopy of the Brain	NCT00949793	Brain Neoplasms	Endomicroscope	18 Years -	Carl Zeiss Surgical GmbH
In Vivo Confocal Microscopy Tumor Atlas Study	NCT01012154	Brain Neoplasms	Endomicroscope	18 Years -	Carl Zeiss Surgical GmbH
In Vivo Confocal Microscopy Tumor Atlas Study	NCT01012154	Brain Neoplasms	Endomicroscope	18 Years -	Carl Zeiss Surgical GmbH
In Vivo Confocal Endomicroscopy of the Brain	NCT00949793	Brain Neoplasms	Endomicroscope	18 Years -	Carl Zeiss Surgical GmbH
Chromoscopic Guided Endomicroscpy to Diagnose Colitis Associated Dysplasia	NCT00352404	Ulcerative Coli... Intraepithelial... Cancer	Endomicroscope	18 Years - 80 Years	Johannes Gutenberg University Mainz
Chromoscopic Guided Endomicroscpy to Diagnose Colitis Associated Dysplasia	NCT00352404	Ulcerative Coli... Intraepithelial... Cancer	Endomicroscope	18 Years - 80 Years	Johannes Gutenberg University Mainz

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